Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
Conditions
Keywords
Absorb™ BVS, Angioplasty, Bioabsorbable, BVS, Coronary Artery Disease, Coronary Artery Endothelial Responsiveness, Coronary artery restenosis, Coronary artery stenosis, Coronary scaffold, Coronary Stent, Drug eluting stents, Everolimus, Myocardial ischemia, Stent thrombosis, Stents
Brief summary
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS. The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.
Detailed description
ABSORB IV: A. Primary Objective: * To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. * To evaluate long-term clinical outcomes of Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three denovo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. B. Secondary Objectives: * To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. * To evaluate the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE. The enrollment of the 2610 subjects in ABSORB IV will start after enrollment completion of the 2000 primary analysis subjects in ABSORB III. All registered subjects will have clinical follow-up at 30, 90, 180, 270 days and 1, 2, 3, 4 and 5 years. Note: All registered subjects in ABSORB IV will be followed up to 5 years via telephone contact/office visit if it is necessary as determined by the Sponsor. In addition, all 2610 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, 1 year, 3 years and 5 years.
Interventions
DEVICEAbsorb BVS
* Scaffold diameters: 2.5, 3.0 and 3.5 mm * Scaffold lengths: 8, 12, 18, and 28 mm. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. * Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm. * The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
DEVICEXIENCE
Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). * Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm. The 3.25 mm is only available for XIENCE Xpedition * Stent lengths: 8, 12, 15, 18, 23, and 28 mm * For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Subject must be at least 18 years of age. 2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements. 3. Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions: 1. Unstable angina or NSTEMI within 2 weeks of the index procedure. 2. STEMI \> 72 hours ≤ 2 weeks prior to the index procedure. Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring \> 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class. 4. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and \< 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR). (Note: subject with silent ischemia must have a prior history of typical angina, angina-equivalent symptoms, or atypical angina within the past year to be included in the trial.) 5. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. 6. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard. 7. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for at least 1 year following the index procedure. 8. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 5 years following the index procedure. Angiographic Inclusion Criteria: Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion treatment can occur only in a non-target vessel. If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion for lesion (and stent) length determination and must be treated with a single study device. 1\. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥50% and \< 100%, with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1, and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve ≤0.80 AND/OR a positive stress test), or presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of index procedure, or STEMI \>72 hours but ≤ 2 weeks prior to the index procedure). 1. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm. 2. Target lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm. Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring \> 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class. Note: To exclude enrollment of excessively small vessels, if the operator believes that based on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). This measurement may be performed before or after pre-dilatation, but before randomization. If the distal RVD measures \<2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such a lesion may be treated as a non-target lesion. General
Exclusion criteria
1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 receptor inhibitor is planned within 12 months after the procedure. 2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated. 3. Subject has known allergic reaction, hypersensitivity or contraindication to any of the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and bivalirudin, and therefore cannot be adequately treated with study medications. 4. Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) within 72 hours of the index procedure. 5. Subject has a cardiac arrhythmia identified at the time of screening for which at least one of the following criteria is met: 1. Subject requires coumadin or any other agent for chronic oral anticoagulation. 2. Subject is likely to become hemodynamically unstable due to their arrhythmia. 3. Subject has poor survival prognosis due to their arrhythmia. 6. Subject has a left ventricular ejection fraction (LVEF) \< 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, multiple-gated acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left ventriculography during the index procedure but prior to randomization in order to confirm the subject's eligibility. 7. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime \>30 days before the index procedure, or between a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated. 8. Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular interventions \< 30 days after the index procedure. 9. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants. 10. At the time of screening, the subject has a malignancy that is not in remission. 11. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy. 12. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum. 13. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for any reason). 14. Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3. 15. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B. 16. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) \< 30 ml/min/1.73m2 or dialysis at the time of screening. 17. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastrointestinal or significant urinary bleed within the past six months. 18. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.). 19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used. 20. Subject has a life expectancy \<5 years for any non-cardiac or cardiac cause. 21. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments. 22. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 23. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Lesion Failure (TLF) | 30 days | Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angina at 1-year, Non-inferiority Against the Control | 1 year | * Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC). * This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first. |
| Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) | In-hospital (≤ 7days) | Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success. |
| Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) | In-hospital (≤ 7days) | Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). |
| Number of Death (Cardiac, Vascular, Non-cardiovascular) | In-hospital (≤ 7 days post index procedure) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
| Number of Participants With Myocardial Infarction (MI) | In-hospital (≤ 7 days post index procedure) | * Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI) |
| Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | In-hospital (≤ 7 days post index procedure) | Myocardial infarction attributed to target vessel myocardial infarction (TV-MI) |
| Number of Participants With Target Lesion Revascularization (TLR) | In-hospital (≤ 7 days post index procedure) | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
| Number of Participants withTarget Lesion Revascularization (TLR) | 90 days | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography. |
| Number of Participants With Ischemia Driven TLR (ID-TLR) | In-hospital (≤ 7 days post index procedure) | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography |
| Number of Participants With Target Vessel Revascularization (TVR) | In-hospital (≤ 7 days post index procedure) | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR |
| Number of Participants With ID-TVR Excluding TLR | In-hospital (≤ 7 days post index procedure) | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR |
| Number of Participants With All Coronary Revascularization | In-hospital (≤ 7 days post index procedure) | Revascularization includes TLR, TVR excluding TLR, and non TVR. |
| Number of Participants Experienced All Death/All MI | In-hospital (≤ 7 days post index procedure) | All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
| Number of Participants Experienced Cardiac Death/All MI | In-hospital (≤ 7 days post index procedure) | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
| TLF at 1-year, Non-inferiority Against the Control | 1 year | One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025. |
| Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | In-hospital (≤ 7 days post index procedure) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
| Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE) | 30 days | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
| Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 90 days | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
| Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF) | In-hospital (≤ 7 days post index procedure) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
| Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 30 days | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
| Number of Participants Experienced Death/All MI/All Revascularization (DMR) | In-hospital (≤ 7 days post index procedure) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
| Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) | 0 - 24 hours post stent implantation | Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation). |
| Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) | >24 hours - 30 days post stent implantation | Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation). |
| Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) | 30 days - 1 year post stent implantation | Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation). |
| Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) | 0 to 730 Days | Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained |
| Number of Participants With Rehospitalization | 30 days | * Coronary artery disease (CAD) related * Cardiovascular, non-CAD related * Non-cardiovascular related |
| Number of Participants With Repeat Coronary Arteriography | In-hospital (≤ 7 days post index procedure) | — |
| Number of Participants With Target Lesion Failure (TLF) | 1 year | The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV) |
| Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | In-hospital (≤ 7 days post index procedure) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
Countries
Australia, Canada, Germany, Singapore, United States
Participant flow
Recruitment details
A total of 2604 subjects were randomized at 147 sites between August 15, 2014 and March 31, 2017. The last 5-year follow-up visit occurred on April 06, 2022. The database was then cleaned, and data extraction for the 5-year analysis occurred on July 29, 2022.
Pre-assignment details
The number of All-Cause Mortality will differ from that reported in the Participant Flow module. This is due to the follow-up window 'treatment' of the data. Only deaths that occurred prior to the beginning of the 5-year visit window (Day 1797=1825-28) are counted in the Participant Flow; whereas in the AE table, participants who died within the follow-up window are counted.
Participants by arm
| Arm | Count |
|---|---|
| Absorb BVS Subjects receiving public) Absorb Bioresorbable Vascular Scaffold (BVS), and the Absorb GT1™ BVS System | 1,296 |
| XIENCE Subjects receiving XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) or XIENCE ProX (outside of the US only) | 1,308 |
| Total | 2,604 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 75 | 72 |
| Overall Study | Lost to Follow-up | 89 | 81 |
| Overall Study | Other Reason | 1 | 0 |
| Overall Study | Physician Decision | 8 | 8 |
| Overall Study | Withdrawal by Subject | 24 | 29 |
Baseline characteristics
| Characteristic | Total | XIENCE | Absorb BVS |
|---|---|---|---|
| Age, Continuous | 62.65 years STANDARD_DEVIATION 10.2 | 62.2 years STANDARD_DEVIATION 10.3 | 63.1 years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 69 Participants | 29 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2535 Participants | 1279 Participants | 1256 Participants |
| Prior Coronary Intervention | 825 Participants | 435 Participants | 390 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 66 Participants | 36 Participants | 30 Participants |
| Race (NIH/OMB) Black or African American | 132 Participants | 61 Participants | 71 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 15 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 84 Participants | 39 Participants | 45 Participants |
| Race (NIH/OMB) White | 2295 Participants | 1160 Participants | 1135 Participants |
| Region of Enrollment Australia | 148 participants | 68 participants | 80 participants |
| Region of Enrollment Canada | 54 participants | 26 participants | 28 participants |
| Region of Enrollment Germany | 335 participants | 171 participants | 164 participants |
| Region of Enrollment Singapore | 5 participants | 2 participants | 3 participants |
| Region of Enrollment United States | 2062 participants | 1041 participants | 1021 participants |
| Sex: Female, Male Female | 730 Participants | 361 Participants | 369 Participants |
| Sex: Female, Male Male | 1874 Participants | 947 Participants | 927 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 77 / 1,296 | 72 / 1,308 |
| other Total, other adverse events | 1,012 / 1,296 | 1,034 / 1,308 |
| serious Total, serious adverse events | 827 / 1,296 | 774 / 1,308 |
Outcome results
Primary
Number of Participants With Target Lesion Failure (TLF)
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Failure (TLF) | 64 Participants |
| XIENCE | Number of Participants With Target Lesion Failure (TLF) | 48 Participants |
Comparison: The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the primary endpoint with a one-sided alpha of 0.025. The null (H0) and alternative (HA) hypotheses are:~H0: TLFAbsorb - TLFXIENCE ≥ ∆TLF HA: TLFAbsorb - TLFXIENCE \< ∆TLF.p-value: 0.0244Farrington-Manning
Secondary
Angina at 1-year, Non-inferiority Against the Control
* Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC). * This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Angina at 1-year, Non-inferiority Against the Control | 459 Participants |
| XIENCE | Angina at 1-year, Non-inferiority Against the Control | 494 Participants |
Secondary
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 1 Participants |
| XIENCE | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 1 Participants |
Secondary
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 5 Participants |
| XIENCE | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 5 Participants |
Secondary
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 7 Participants |
| XIENCE | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 8 Participants |
Secondary
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 10 Participants |
| XIENCE | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 11 Participants |
Secondary
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 16 Participants |
| XIENCE | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 15 Participants |
Secondary
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 22 Participants |
| XIENCE | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 22 Participants |
Secondary
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 39 Participants |
| XIENCE | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 32 Participants |
Secondary
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 54 Participants |
| XIENCE | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 49 Participants |
Secondary
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. For the All-Cause Mortality data, the denominator excludes participants who are lost-to-follow-up or withdrawn (by subject or physician) through a given timepoint without any DMR event (all death, MI and revascularization, respectively). If these participants were included in the denominator in each arm, that would equate to assuming that these participants are alive, potentially underestimating the death rate by inflating the denominator.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 77 Participants |
| XIENCE | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 72 Participants |
Secondary
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 1 Participants |
| XIENCE | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 0 Participants |
Secondary
Number of Participants Experienced All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced All Death/All MI | 209 Participants |
| XIENCE | Number of Participants Experienced All Death/All MI | 188 Participants |
Secondary
Number of Participants Experienced All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced All Death/All MI | 150 Participants |
| XIENCE | Number of Participants Experienced All Death/All MI | 132 Participants |
Secondary
Number of Participants Experienced All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced All Death/All MI | 116 Participants |
| XIENCE | Number of Participants Experienced All Death/All MI | 106 Participants |
Secondary
Number of Participants Experienced All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced All Death/All MI | 89 Participants |
| XIENCE | Number of Participants Experienced All Death/All MI | 79 Participants |
Secondary
Number of Participants Experienced All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced All Death/All MI | 80 Participants |
| XIENCE | Number of Participants Experienced All Death/All MI | 72 Participants |
Secondary
Number of Participants Experienced All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced All Death/All MI | 74 Participants |
| XIENCE | Number of Participants Experienced All Death/All MI | 64 Participants |
Secondary
Number of Participants Experienced All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced All Death/All MI | 69 Participants |
| XIENCE | Number of Participants Experienced All Death/All MI | 55 Participants |
Secondary
Number of Participants Experienced All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced All Death/All MI | 59 Participants |
| XIENCE | Number of Participants Experienced All Death/All MI | 48 Participants |
Secondary
Number of Participants Experienced All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced All Death/All MI | 51 Participants |
| XIENCE | Number of Participants Experienced All Death/All MI | 43 Participants |
Secondary
Number of Participants Experienced All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced All Death/All MI | 181 Participants |
| XIENCE | Number of Participants Experienced All Death/All MI | 159 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI | 171 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI | 155 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI | 67 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI | 53 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI | 51 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI | 43 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI | 59 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI | 47 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI | 71 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI | 61 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI | 77 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI | 68 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI | 83 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI | 73 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI | 107 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI | 96 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI | 133 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI | 118 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI | 157 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI | 137 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF) | 57 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF) | 44 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 163 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 139 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 111 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 101 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 101 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 86 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 86 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 75 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 77 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 59 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 66 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 48 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 246 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 203 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 262 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 240 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 211 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) | 171 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 233 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 207 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 183 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 152 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 146 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 121 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 102 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 89 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 93 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 77 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 80 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 67 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 74 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 55 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 217 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) | 178 Participants |
Secondary
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | 57 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | 44 Participants |
Secondary
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 57 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 44 Participants |
Secondary
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 98 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 83 Participants |
Secondary
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 138 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 107 Participants |
Secondary
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 171 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 134 Participants |
Secondary
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 200 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 153 Participants |
Secondary
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 216 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 180 Participants |
Secondary
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 64 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 48 Participants |
Secondary
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 71 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 53 Participants |
Secondary
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 90 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 71 Participants |
Secondary
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 77 Participants |
| XIENCE | Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | 64 Participants |
Secondary
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 185 Participants |
| XIENCE | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 161 Participants |
Secondary
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 125 Participants |
| XIENCE | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 114 Participants |
Secondary
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 110 Participants |
| XIENCE | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 97 Participants |
Secondary
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 94 Participants |
| XIENCE | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 82 Participants |
Secondary
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 81 Participants |
| XIENCE | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 65 Participants |
Secondary
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 57 Participants |
| XIENCE | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 46 Participants |
Secondary
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 67 Participants |
| XIENCE | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 53 Participants |
Secondary
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 310 Participants |
| XIENCE | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 284 Participants |
Secondary
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 281 Participants |
| XIENCE | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 239 Participants |
Secondary
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 241 Participants |
| XIENCE | Number of Participants Experienced Death/All MI/All Revascularization (DMR) | 198 Participants |
Secondary
Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE) | 65 Participants |
| XIENCE | Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE) | 48 Participants |
Secondary
Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: 0 - 24 hours post stent implantation
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS | Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) | Definite | 3 Participants |
| Absorb BVS | Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) | Definite/Probable | 4 Participants |
| Absorb BVS | Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) | Probable | 1 Participants |
| XIENCE | Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) | Definite | 0 Participants |
| XIENCE | Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) | Definite/Probable | 0 Participants |
| XIENCE | Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) | Probable | 0 Participants |
Secondary
Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)
Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
Time frame: In-hospital (≤ 7days)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) | 1194 Participants |
| XIENCE | Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) | 1246 Participants |
Secondary
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With All Coronary Revascularization | 198 Participants |
| XIENCE | Number of Participants With All Coronary Revascularization | 167 Participants |
Secondary
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With All Coronary Revascularization | 64 Participants |
| XIENCE | Number of Participants With All Coronary Revascularization | 51 Participants |
Secondary
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With All Coronary Revascularization | 41 Participants |
| XIENCE | Number of Participants With All Coronary Revascularization | 30 Participants |
Secondary
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With All Coronary Revascularization | 54 Participants |
| XIENCE | Number of Participants With All Coronary Revascularization | 39 Participants |
Secondary
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With All Coronary Revascularization | 117 Participants |
| XIENCE | Number of Participants With All Coronary Revascularization | 89 Participants |
Secondary
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With All Coronary Revascularization | 10 Participants |
| XIENCE | Number of Participants With All Coronary Revascularization | 4 Participants |
Secondary
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With All Coronary Revascularization | 19 Participants |
| XIENCE | Number of Participants With All Coronary Revascularization | 8 Participants |
Secondary
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With All Coronary Revascularization | 28 Participants |
| XIENCE | Number of Participants With All Coronary Revascularization | 15 Participants |
Secondary
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With All Coronary Revascularization | 157 Participants |
| XIENCE | Number of Participants With All Coronary Revascularization | 113 Participants |
Secondary
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With All Coronary Revascularization | 185 Participants |
| XIENCE | Number of Participants With All Coronary Revascularization | 141 Participants |
Secondary
Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained
Time frame: 0 to 730 Days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS | Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) | Definite | 11 Participants |
| Absorb BVS | Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) | Definite/Probable | 12 Participants |
| Absorb BVS | Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) | Probable | 1 Participants |
| XIENCE | Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) | Definite | 6 Participants |
| XIENCE | Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) | Definite/Probable | 6 Participants |
| XIENCE | Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) | Probable | 0 Participants |
Secondary
Number of Participants With ID-TVR Excluding TLR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With ID-TVR Excluding TLR | 10 Participants |
| XIENCE | Number of Participants With ID-TVR Excluding TLR | 6 Participants |
Secondary
Number of Participants With ID-TVR Excluding TLR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With ID-TVR Excluding TLR | 14 Participants |
| XIENCE | Number of Participants With ID-TVR Excluding TLR | 14 Participants |
Secondary
Number of Participants With ID-TVR Excluding TLR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With ID-TVR Excluding TLR | 19 Participants |
| XIENCE | Number of Participants With ID-TVR Excluding TLR | 16 Participants |
Secondary
Number of Participants With ID-TVR Excluding TLR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With ID-TVR Excluding TLR | 22 Participants |
| XIENCE | Number of Participants With ID-TVR Excluding TLR | 20 Participants |
Secondary
Number of Participants With ID-TVR Excluding TLR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With ID-TVR Excluding TLR | 42 Participants |
| XIENCE | Number of Participants With ID-TVR Excluding TLR | 38 Participants |
Secondary
Number of Participants With ID-TVR Excluding TLR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With ID-TVR Excluding TLR | 65 Participants |
| XIENCE | Number of Participants With ID-TVR Excluding TLR | 48 Participants |
Secondary
Number of Participants With ID-TVR Excluding TLR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With ID-TVR Excluding TLR | 80 Participants |
| XIENCE | Number of Participants With ID-TVR Excluding TLR | 65 Participants |
Secondary
Number of Participants With ID-TVR Excluding TLR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With ID-TVR Excluding TLR | 89 Participants |
| XIENCE | Number of Participants With ID-TVR Excluding TLR | 80 Participants |
Secondary
Number of Participants With ID-TVR Excluding TLR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With ID-TVR Excluding TLR | 3 Participants |
| XIENCE | Number of Participants With ID-TVR Excluding TLR | 0 Participants |
Secondary
Number of Participants With ID-TVR Excluding TLR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With ID-TVR Excluding TLR | 5 Participants |
| XIENCE | Number of Participants With ID-TVR Excluding TLR | 1 Participants |
Secondary
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Ischemia Driven TLR (ID-TLR) | 13 Participants |
| XIENCE | Number of Participants With Ischemia Driven TLR (ID-TLR) | 3 Participants |
Secondary
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Ischemia Driven TLR (ID-TLR) | 22 Participants |
| XIENCE | Number of Participants With Ischemia Driven TLR (ID-TLR) | 11 Participants |
Secondary
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Ischemia Driven TLR (ID-TLR) | 32 Participants |
| XIENCE | Number of Participants With Ischemia Driven TLR (ID-TLR) | 15 Participants |
Secondary
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Ischemia Driven TLR (ID-TLR) | 8 Participants |
| XIENCE | Number of Participants With Ischemia Driven TLR (ID-TLR) | 1 Participants |
Secondary
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Ischemia Driven TLR (ID-TLR) | 37 Participants |
| XIENCE | Number of Participants With Ischemia Driven TLR (ID-TLR) | 24 Participants |
Secondary
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Ischemia Driven TLR (ID-TLR) | 67 Participants |
| XIENCE | Number of Participants With Ischemia Driven TLR (ID-TLR) | 38 Participants |
Secondary
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Ischemia Driven TLR (ID-TLR) | 87 Participants |
| XIENCE | Number of Participants With Ischemia Driven TLR (ID-TLR) | 50 Participants |
Secondary
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Ischemia Driven TLR (ID-TLR) | 104 Participants |
| XIENCE | Number of Participants With Ischemia Driven TLR (ID-TLR) | 65 Participants |
Secondary
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Ischemia Driven TLR (ID-TLR) | 111 Participants |
| XIENCE | Number of Participants With Ischemia Driven TLR (ID-TLR) | 82 Participants |
Secondary
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Ischemia Driven TLR (ID-TLR) | 15 Participants |
| XIENCE | Number of Participants With Ischemia Driven TLR (ID-TLR) | 4 Participants |
Secondary
Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: 30 days - 1 year post stent implantation
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS | Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) | Definite | 1 Participants |
| Absorb BVS | Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) | Definite/Probable | 1 Participants |
| Absorb BVS | Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) | Probable | 0 Participants |
| XIENCE | Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) | Definite | 2 Participants |
| XIENCE | Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) | Definite/Probable | 2 Participants |
| XIENCE | Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) | Probable | 0 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI)
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Myocardial Infarction (MI) | 126 Participants |
| XIENCE | Number of Participants With Myocardial Infarction (MI) | 104 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI)
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Myocardial Infarction (MI) | 145 Participants |
| XIENCE | Number of Participants With Myocardial Infarction (MI) | 119 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI)
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Myocardial Infarction (MI) | 154 Participants |
| XIENCE | Number of Participants With Myocardial Infarction (MI) | 134 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI)
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Myocardial Infarction (MI) | 104 Participants |
| XIENCE | Number of Participants With Myocardial Infarction (MI) | 86 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI)
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Myocardial Infarction (MI) | 50 Participants |
| XIENCE | Number of Participants With Myocardial Infarction (MI) | 43 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI)
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Myocardial Infarction (MI) | 58 Participants |
| XIENCE | Number of Participants With Myocardial Infarction (MI) | 47 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI)
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Myocardial Infarction (MI) | 66 Participants |
| XIENCE | Number of Participants With Myocardial Infarction (MI) | 50 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI)
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Myocardial Infarction (MI) | 70 Participants |
| XIENCE | Number of Participants With Myocardial Infarction (MI) | 56 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI)
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Myocardial Infarction (MI) | 75 Participants |
| XIENCE | Number of Participants With Myocardial Infarction (MI) | 62 Participants |
Secondary
Number of Participants With Myocardial Infarction (MI)
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Myocardial Infarction (MI) | 80 Participants |
| XIENCE | Number of Participants With Myocardial Infarction (MI) | 65 Participants |
Secondary
Number of Participants With Rehospitalization
* CAD related * Cardiovascular, non-CAD related * Non-cardiovascular related
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Rehospitalization | 612 Participants |
| XIENCE | Number of Participants With Rehospitalization | 578 Participants |
Secondary
Number of Participants With Rehospitalization
* CAD related * Cardiovascular, non-CAD related * Non-cardiovascular related
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Rehospitalization | 544 Participants |
| XIENCE | Number of Participants With Rehospitalization | 525 Participants |
Secondary
Number of Participants With Rehospitalization
* Coronary artery disease (CAD) related * Cardiovascular, non-CAD related * Non-cardiovascular related
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Rehospitalization | 66 Participants |
| XIENCE | Number of Participants With Rehospitalization | 59 Participants |
Secondary
Number of Participants With Rehospitalization
* CAD related * Cardiovascular, non-CAD related * Non-cardiovascular related
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Rehospitalization | 443 Participants |
| XIENCE | Number of Participants With Rehospitalization | 446 Participants |
Secondary
Number of Participants With Rehospitalization
* CAD related * Cardiovascular, non-CAD related * Non-cardiovascular related
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Rehospitalization | 277 Participants |
| XIENCE | Number of Participants With Rehospitalization | 289 Participants |
Secondary
Number of Participants With Rehospitalization
* CAD related * Cardiovascular, non-CAD related * Non-cardiovascular related
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Rehospitalization | 227 Participants |
| XIENCE | Number of Participants With Rehospitalization | 237 Participants |
Secondary
Number of Participants With Rehospitalization
* CAD related * Cardiovascular, non-CAD related * Non-cardiovascular related
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Rehospitalization | 654 Participants |
| XIENCE | Number of Participants With Rehospitalization | 621 Participants |
Secondary
Number of Participants With Rehospitalization
* CAD related * Cardiovascular, non-CAD related * Non-cardiovascular related
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Rehospitalization | 178 Participants |
| XIENCE | Number of Participants With Rehospitalization | 178 Participants |
Secondary
Number of Participants With Rehospitalization
* CAD related * Cardiovascular, non-CAD related * Non-cardiovascular related
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Rehospitalization | 111 Participants |
| XIENCE | Number of Participants With Rehospitalization | 122 Participants |
Secondary
Number of Participants With Repeat Coronary Arteriography
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Repeat Coronary Arteriography | 4 Participants |
| XIENCE | Number of Participants With Repeat Coronary Arteriography | 7 Participants |
Secondary
Number of Participants With Repeat Coronary Arteriography
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Repeat Coronary Arteriography | 57 Participants |
| XIENCE | Number of Participants With Repeat Coronary Arteriography | 64 Participants |
Secondary
Number of Participants With Repeat Coronary Arteriography
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Repeat Coronary Arteriography | 33 Participants |
| XIENCE | Number of Participants With Repeat Coronary Arteriography | 40 Participants |
Secondary
Number of Participants With Repeat Coronary Arteriography
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Repeat Coronary Arteriography | 84 Participants |
| XIENCE | Number of Participants With Repeat Coronary Arteriography | 103 Participants |
Secondary
Number of Participants With Repeat Coronary Arteriography
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Repeat Coronary Arteriography | 71 Participants |
| XIENCE | Number of Participants With Repeat Coronary Arteriography | 87 Participants |
Secondary
Number of Participants With Repeat Coronary Arteriography
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Repeat Coronary Arteriography | 18 Participants |
| XIENCE | Number of Participants With Repeat Coronary Arteriography | 21 Participants |
Secondary
Number of Participants With Repeat Coronary Arteriography
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Repeat Coronary Arteriography | 225 Participants |
| XIENCE | Number of Participants With Repeat Coronary Arteriography | 237 Participants |
Secondary
Number of Participants With Repeat Coronary Arteriography
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Repeat Coronary Arteriography | 209 Participants |
| XIENCE | Number of Participants With Repeat Coronary Arteriography | 220 Participants |
Secondary
Number of Participants With Repeat Coronary Arteriography
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Repeat Coronary Arteriography | 186 Participants |
| XIENCE | Number of Participants With Repeat Coronary Arteriography | 188 Participants |
Secondary
Number of Participants With Repeat Coronary Arteriography
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Repeat Coronary Arteriography | 140 Participants |
| XIENCE | Number of Participants With Repeat Coronary Arteriography | 161 Participants |
Secondary
Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Time frame: >24 hours - 30 days post stent implantation
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS | Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) | Definite | 4 Participants |
| Absorb BVS | Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) | Definite/Probable | 4 Participants |
| Absorb BVS | Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) | Probable | 0 Participants |
| XIENCE | Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) | Definite | 2 Participants |
| XIENCE | Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) | Definite/Probable | 2 Participants |
| XIENCE | Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) | Probable | 0 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Failure (TLF) | 98 Participants |
| XIENCE | Number of Participants With Target Lesion Failure (TLF) | 83 Participants |
Secondary
Number of Participants withTarget Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants withTarget Lesion Revascularization (TLR) | 16 Participants |
| XIENCE | Number of Participants withTarget Lesion Revascularization (TLR) | 4 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Revascularization (TLR) | 8 Participants |
| XIENCE | Number of Participants With Target Lesion Revascularization (TLR) | 1 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Revascularization (TLR) | 114 Participants |
| XIENCE | Number of Participants With Target Lesion Revascularization (TLR) | 82 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Revascularization (TLR) | 107 Participants |
| XIENCE | Number of Participants With Target Lesion Revascularization (TLR) | 65 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Revascularization (TLR) | 90 Participants |
| XIENCE | Number of Participants With Target Lesion Revascularization (TLR) | 50 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Revascularization (TLR) | 70 Participants |
| XIENCE | Number of Participants With Target Lesion Revascularization (TLR) | 38 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Revascularization (TLR) | 38 Participants |
| XIENCE | Number of Participants With Target Lesion Revascularization (TLR) | 24 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Revascularization (TLR) | 33 Participants |
| XIENCE | Number of Participants With Target Lesion Revascularization (TLR) | 15 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Revascularization (TLR) | 23 Participants |
| XIENCE | Number of Participants With Target Lesion Revascularization (TLR) | 11 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Lesion Revascularization (TLR) | 14 Participants |
| XIENCE | Number of Participants With Target Lesion Revascularization (TLR) | 3 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time frame: 4 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 126 Participants |
| XIENCE | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 94 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 57 Participants |
| XIENCE | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 47 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 63 Participants |
| XIENCE | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 48 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time frame: 5 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 134 Participants |
| XIENCE | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 106 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 50 Participants |
| XIENCE | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 43 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 67 Participants |
| XIENCE | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 53 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 71 Participants |
| XIENCE | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 56 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 75 Participants |
| XIENCE | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 58 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time frame: 2 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 94 Participants |
| XIENCE | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 72 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time frame: 3 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 112 Participants |
| XIENCE | Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | 86 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Revascularization (TVR) | 82 Participants |
| XIENCE | Number of Participants With Target Vessel Revascularization (TVR) | 66 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Revascularization (TVR) | 44 Participants |
| XIENCE | Number of Participants With Target Vessel Revascularization (TVR) | 39 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Revascularization (TVR) | 67 Participants |
| XIENCE | Number of Participants With Target Vessel Revascularization (TVR) | 49 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Revascularization (TVR) | 91 Participants |
| XIENCE | Number of Participants With Target Vessel Revascularization (TVR) | 81 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: In-hospital (≤ 7 days post index procedure)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Revascularization (TVR) | 3 Participants |
| XIENCE | Number of Participants With Target Vessel Revascularization (TVR) | 0 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 30 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Revascularization (TVR) | 5 Participants |
| XIENCE | Number of Participants With Target Vessel Revascularization (TVR) | 1 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 90 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Revascularization (TVR) | 10 Participants |
| XIENCE | Number of Participants With Target Vessel Revascularization (TVR) | 6 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR. -TVR includes all TVR, excluding TLR
Time frame: 180 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Revascularization (TVR) | 14 Participants |
| XIENCE | Number of Participants With Target Vessel Revascularization (TVR) | 14 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 270 days
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Revascularization (TVR) | 19 Participants |
| XIENCE | Number of Participants With Target Vessel Revascularization (TVR) | 16 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | Number of Participants With Target Vessel Revascularization (TVR) | 22 Participants |
| XIENCE | Number of Participants With Target Vessel Revascularization (TVR) | 20 Participants |
Secondary
Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)
Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Time frame: In-hospital (≤ 7days)
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb BVS | Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) | 94.6 Percentage of target lesions |
| XIENCE | Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) | 99.0 Percentage of target lesions |
Secondary
TLF at 1-year, Non-inferiority Against the Control
One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.
Time frame: 1 year
Population: ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS | TLF at 1-year, Non-inferiority Against the Control | 98 Participants |
| XIENCE | TLF at 1-year, Non-inferiority Against the Control | 82 Participants |
p-value: 0.0006Farrington-Manning