Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
Conditions
Keywords
Absorb™ BVS, Angioplasty, Bioabsorbable, BVS, Bioresorbable, 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
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
Interventions
DEVICEXIENCE V EECSS
Subjects receiving XIENCE V
DEVICEAbsorb BVS System
Subjects receiving Absorb BVS System
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be at least 18 years of age at the time of signing the informed consent form. 2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure. 3. Subject must have evidence of myocardial ischemia (e.g., stable angina, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and \< 70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia. 4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. 5. Female subject of childbearing potential 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 14 days (≤14 days) prior to the index procedure per site standard test. 6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure. 7. Subject agrees to not participate in any other investigational clinical studies for a period of 1 year following the index procedure.
Exclusion criteria
1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or P2Y12 inhibitor is planned within 12 months after the index procedure. 2. Subject has a known hypersensitivity or contraindication to device material (cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers) and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid). Subject has a known contrast sensitivity that cannot be adequately pre-medicated. 3. Subject has a known allergic reaction, hypersensitivity or contraindication to: 1. Aspirin; or 2. All P2Y12 inhibitors (including clopidogrel and ticlopidine, and prasugrel and ticagrelor when they become available); or 3. Heparin and bivalirudin. 4. Subject had an acute myocardial infarction (AMI) within 7 days of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure. 5. Subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes. 6. Subject has a cardiac arrhythmia as identified at the time of screening which at least one of the following criteria is met: 1. Subject requires coumadin or any other agent for chronic oral anticoagulation. 2. Subject likely to become hemodynamically unstable due to their arrhythmia. 3. Subject has poor survival prognosis due to their arrhythmia. 7. Subject has a known left ventricular ejection fraction (LVEF) \< 30% assessed by any quantitative method. LVEF may be obtained within 6 months prior to the procedure for subjects with stable coronary artery disease (CAD). For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility. 8. Subject has received CABG at any time in the past. 9. Subject has undergone prior PCI within the target vessel during the last 12 months or undergone prior PCI within the non-target vessel within 30 days before the index procedure. 10. Subject requires future staged PCI either in target or non-target vessels. 11. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants. 12. At the time of screening, the subject has a malignancy that is not in remission. 13. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy. 14. Subject has previously received or is scheduled to receive radiotherapy to coronary artery (vascular brachytherapy), or chest/mediastinum. 15. Subject is receiving or will receive chronic anticoagulation therapy (e.g., coumadin or any other anticoagulation agents). 16. Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3. 17. Subject has a known or documented hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B. 18. Subject has known renal insufficiency as defined as an estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 or dialysis at the time of screening. 19. Subject is high risk of bleeding; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months; will refuse blood transfusions. 20. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months or any prior intracranial bleed, any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.). 21. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the subject if radial or brachial access can be used. 22. Subject has life expectancy \< 2 years for any non-cardiac cause or cardiac cause. 23. 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. 24. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint or protocol-required medications or invasive procedures. Angiographic Inclusion Criteria Assessment of angiographic eligibility is per visual assessment by an investigator both for qualitative and quantitative variables. On-line QCA is recommended to be used for appropriately sizing of the vessel. If on-line QCA cannot be used, visual estimation is required. 1. One or two de novo target lesions: 1. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion. 2. If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria. 3. The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch. 2. Target lesion 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, stress test), unstable angina or post-infarct angina. 3. Target lesion must have a Dmax (by on-line QCA) or reference vessel diameter (RVD) (by visual estimation) ≥ 2.50 mm and ≤ 3.75 mm (on-line QCA assessment is recommended). 4. Target lesion must have a lesion length ≤ 24 mm based on either visual estimation or on-line QCA. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-segment Late Loss (LL) - Per Subject Analysis | 1 year | In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography. |
| In-segment Late Loss (LL) - Per Lesion Analysis | 1 year | In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-Device Late Loss (LL) | 1 year | In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup). |
| Acute Device Success | < or = 1 day | Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by 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. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only. |
| Number of Participants With Acute Procedural Success | At time of procedure up to 7 days in hospital | 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 assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only. |
| Number of Death (Cardiac, Vascular, Non-cardiovascular) | ≤ 7 days post index procedure (In-hospital ) | 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. |
| Number of Participants With Myocardial Infarction | ≤ 7 days post index procedure (In-hospital ) | MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study. |
| Number of Participants With Target Lesion Revascularization (TLR) | ≤ 7 days post index procedure (In-hospital ) | * Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR) |
| Number of Participants With Target Vessel Revascularization (TVR) | ≤ 7 days post index procedure (In-hospital ) | * Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR) |
| Number of Participants With All Coronary Revascularization (PCI and CABG) | ≤ 7 days post index procedure (In-hospital ) | All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) |
| Number of Death/All MI | ≤ 7 days post index procedure (In-hospital ) | 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 Cardiac Death/All MI | ≤ 7 days post index procedure (In-hospital ) | 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. |
| Number of Participants With All Death/All MI/All Revascularization (DMR) | ≤ 7 days post index procedure (In-hospital ) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
| Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | ≤ 7 days post index procedure (In-hospital ) | Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR)) |
| Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | ≤ 7 days post index procedure (In-hospital) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
| Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | ≤ 7 days post index procedure (In-hospital ) | 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 With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition) | < or = 1 day | 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 Stent/Scaffold Thrombosis (Per ARC Definition) | >1 to 30 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 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 Stent/Scaffold Thrombosis (Per ARC Definition) | 31 to 365 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 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 Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition) | 366 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 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 Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) | 731 to 1095 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 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 Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) | 366-1095 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 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 Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition) | 1096-1460 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 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 Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) | 1461-1825 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 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 Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) | 1096-1825 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 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). |
| Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis | 0-1825 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 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). |
| In-Device Minimum Lumen Diameter (MLD) | 1 year | Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. |
| In-Segment Minimum Lumen Diameter (MLD) | 1 year | Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent. |
| Proximal Minimum Lumen Diameter (MLD) | 1 year | Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. |
| Distal Minimum Lumen Diameter (MLD) | 1 year | Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. |
| In-Segment Percent Diameter Stenosis (%DS) | 1 year | The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method. |
| In-Device Percent Diameter Stenosis (%DS) | 1 year | The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method. |
| Proximal Percent Diameter Stenosis (%DS) | 1 year | The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method. |
| Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR) | 1 year | Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. |
| Distal Percent Diameter Stenosis (%DS) | 1 year | The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method. |
| In-Segment Late Loss (LL) | 1 year | In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup). |
| Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR) | 1 year | Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. |
| Proximal Late Loss (LL) | 1 year | Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup. Proximal is defined as within 5 mm of healthy tissue proximal to the device placement. |
| Distal Late Loss (LL) | 1 year | Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup. Distal is defined as within 5 mm of healthy tissue distal to the device placement. |
| Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR) | 1 year | Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent. |
| Percentage of Participants With Distal Angiographic Binary Restenosis (ABR) | 1 year | Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. |
Countries
United States
Participant flow
Recruitment details
The enrollment of the ABSORB China RCT began on July 31, 2013 & completed on March 13, 2014 with the first subject randomized on 2 August 2013. A total of 480 subjects (Intent-to-treat (ITT) population) were randomized (Absorb BVS:241&XIENCE:239) at 24 clinical sites in mainland China. Last subject completed the 5 year follow-up on March 7, 2019.
Pre-assignment details
Of the 480 ITT subjects, 21 were excluded from the PTE population due to pre-specified protocol/treatment deviations or due to subject withdrawal prior to any study device attempts during the index procedure. Thus, of the 459 subjects in the PTE population, 227 were randomized to the Absorb BVS arm and 232 were randomized to the XIENCE V arm
Participants by arm
| Arm | Count |
|---|---|
| Absorb BVS System Absorb BVS System: Subjects receiving Absorb BVS System | 227 |
| XIENCE V EECSS XIENCE V EECSS: Subjects receiving XIENCE V | 232 |
| Total | 459 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 9 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Absorb BVS System | XIENCE V EECSS | Total |
|---|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 11.4 | 57.7 years STANDARD_DEVIATION 9.6 | 57.4 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment China | 227 Participants | 232 Participants | 459 Participants |
| Sex: Female, Male Female | 66 Participants | 61 Participants | 127 Participants |
| Sex: Female, Male Male | 161 Participants | 171 Participants | 332 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 227 | 7 / 232 |
| other Total, other adverse events | 151 / 227 | 135 / 232 |
| serious Total, serious adverse events | 94 / 227 | 81 / 232 |
Outcome results
Primary
In-segment Late Loss (LL) - Per Lesion Analysis
In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | In-segment Late Loss (LL) - Per Lesion Analysis | 0.19 Millimeter | Standard Deviation 0.4 |
| XIENCE V EECSS | In-segment Late Loss (LL) - Per Lesion Analysis | 0.13 Millimeter | Standard Deviation 0.37 |
Primary
In-segment Late Loss (LL) - Per Subject Analysis
In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | In-segment Late Loss (LL) - Per Subject Analysis | 0.19 Millimeter | Standard Deviation 0.38 |
| XIENCE V EECSS | In-segment Late Loss (LL) - Per Subject Analysis | 0.13 Millimeter | Standard Deviation 0.38 |
Secondary
Acute Device Success
Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by 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. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.
Time frame: < or = 1 day
Population: Intent to treat set (ITT). Four subjects (1 in the Absorb BVS arm and 3 in the XIENCE V arm) were excluded from the data analysis for acute success.~During the index procedure, 5 subjects withdrew consent following randomization and before any device attempts,3 in the Absorb BVS arm and 2 in the XIENCE V arm were excluded from all data analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb BVS System | Acute Device Success | 98.0 Percentage of target lesions |
| XIENCE V EECSS | Acute Device Success | 99.6 Percentage of target lesions |
Secondary
Distal Late Loss (LL)
Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup. Distal is defined as within 5 mm of healthy tissue distal to the device placement.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | Distal Late Loss (LL) | 0.08 Millimeter | Standard Deviation 0.31 |
| XIENCE V EECSS | Distal Late Loss (LL) | 0.03 Millimeter | Standard Deviation 0.33 |
Secondary
Distal Minimum Lumen Diameter (MLD)
Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | Distal Minimum Lumen Diameter (MLD) | 2.39 Millimeter | Standard Deviation 0.45 |
| XIENCE V EECSS | Distal Minimum Lumen Diameter (MLD) | 2.37 Millimeter | Standard Deviation 0.5 |
Secondary
Distal Percent Diameter Stenosis (%DS)
The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | Distal Percent Diameter Stenosis (%DS) | 8.53 Percent Diameter stenosis | Standard Deviation 8.15 |
| XIENCE V EECSS | Distal Percent Diameter Stenosis (%DS) | 8.14 Percent Diameter stenosis | Standard Deviation 11.86 |
Secondary
In-Device Late Loss (LL)
In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | In-Device Late Loss (LL) | 0.24 Millimeter | Standard Deviation 0.39 |
| XIENCE V EECSS | In-Device Late Loss (LL) | 0.10 Millimeter | Standard Deviation 0.32 |
Secondary
In-Device Minimum Lumen Diameter (MLD)
Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | In-Device Minimum Lumen Diameter (MLD) | 2.24 Millimeter | Standard Deviation 0.48 |
| XIENCE V EECSS | In-Device Minimum Lumen Diameter (MLD) | 2.50 Millimeter | Standard Deviation 0.46 |
Secondary
In-Device Percent Diameter Stenosis (%DS)
The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | In-Device Percent Diameter Stenosis (%DS) | 19.16 Percent Diameter stenosis | Standard Deviation 14.36 |
| XIENCE V EECSS | In-Device Percent Diameter Stenosis (%DS) | 11.15 Percent Diameter stenosis | Standard Deviation 11.38 |
Secondary
In-Segment Late Loss (LL)
In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | In-Segment Late Loss (LL) | 0.19 Millimeter | Standard Deviation 0.4 |
| XIENCE V EECSS | In-Segment Late Loss (LL) | 0.13 Millimeter | Standard Deviation 0.37 |
Secondary
In-Segment Minimum Lumen Diameter (MLD)
Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | In-Segment Minimum Lumen Diameter (MLD) | 2.11 Millimeter | Standard Deviation 0.47 |
| XIENCE V EECSS | In-Segment Minimum Lumen Diameter (MLD) | 2.17 Millimeter | Standard Deviation 0.49 |
Secondary
In-Segment Percent Diameter Stenosis (%DS)
The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | In-Segment Percent Diameter Stenosis (%DS) | 24.02 Percent Diameter stenosis | Standard Deviation 13.23 |
| XIENCE V EECSS | In-Segment Percent Diameter Stenosis (%DS) | 22.96 Percent Diameter stenosis | Standard Deviation 13.18 |
Secondary
Number of 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Cardiac Death/All MI | 7 Participants |
| XIENCE V EECSS | Number of Cardiac Death/All MI | 5 Participants |
Secondary
Number of 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 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Cardiac Death/All MI | 6 Participants |
| XIENCE V EECSS | Number of Cardiac Death/All MI | 5 Participants |
Secondary
Number of 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Cardiac Death/All MI | 3 Participants |
| XIENCE V EECSS | Number of Cardiac Death/All MI | 4 Participants |
Secondary
Number of 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: 0 to 298 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Cardiac Death/All MI | 2 Participants |
| XIENCE V EECSS | Number of Cardiac Death/All MI | 4 Participants |
Secondary
Number of 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: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Cardiac Death/All MI | 2 Participants |
| XIENCE V EECSS | Number of Cardiac Death/All MI | 4 Participants |
Secondary
Number of 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: 0 to 37 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Cardiac Death/All MI | 2 Participants |
| XIENCE V EECSS | Number of Cardiac Death/All MI | 3 Participants |
Secondary
Number of 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Cardiac Death/All MI | 9 Participants |
| XIENCE V EECSS | Number of Cardiac Death/All MI | 6 Participants |
Secondary
Number of 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: ≤ 7 days post index procedure (In-hospital )
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Cardiac Death/All MI | 1 Participants |
| XIENCE V EECSS | Number of Cardiac Death/All MI | 2 Participants |
Secondary
Number of 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Cardiac Death/All MI | 10 Participants |
| XIENCE V EECSS | Number of Cardiac Death/All MI | 6 Participants |
Secondary
Number of 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 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death/All MI | 6 Participants |
| XIENCE V EECSS | Number of Death/All MI | 8 Participants |
Secondary
Number of 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death/All MI | 13 Participants |
| XIENCE V EECSS | Number of Death/All MI | 10 Participants |
Secondary
Number of 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death/All MI | 11 Participants |
| XIENCE V EECSS | Number of Death/All MI | 10 Participants |
Secondary
Number of 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: ≤ 7 days post index procedure (In-hospital )
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death/All MI | 1 Participants |
| XIENCE V EECSS | Number of Death/All MI | 2 Participants |
Secondary
Number of 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: 0 to 37 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death/All MI | 2 Participants |
| XIENCE V EECSS | Number of Death/All MI | 3 Participants |
Secondary
Number of 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: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death/All MI | 2 Participants |
| XIENCE V EECSS | Number of Death/All MI | 6 Participants |
Secondary
Number of 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: 0 to 298 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death/All MI | 2 Participants |
| XIENCE V EECSS | Number of Death/All MI | 6 Participants |
Secondary
Number of 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death/All MI | 3 Participants |
| XIENCE V EECSS | Number of Death/All MI | 6 Participants |
Secondary
Number of 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death/All MI | 8 Participants |
| XIENCE V EECSS | Number of Death/All MI | 8 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. 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.
Time frame: 2 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 1 Participants |
| XIENCE V EECSS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 5 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. 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.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 0 Participants |
| XIENCE V EECSS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 4 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. 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.
Time frame: 0 to 298 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 0 Participants |
| XIENCE V EECSS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 4 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. 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.
Time frame: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 0 Participants |
| XIENCE V EECSS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 3 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. 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.
Time frame: 0 to 37days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 0 Participants |
| XIENCE V EECSS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 0 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. 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.
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 0 Participants |
| XIENCE V EECSS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 0 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. 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
Time frame: 5 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 6 Participants |
| XIENCE V EECSS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 7 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. 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.
Time frame: 4 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 4 Participants |
| XIENCE V EECSS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 7 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. 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.
Time frame: 3 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 2 Participants |
| XIENCE V EECSS | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 5 Participants |
Secondary
Number of Participants With Acute Procedural Success
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 assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.
Time frame: At time of procedure up to 7 days in hospital
Population: ITT set. Four subjects (Absorb BVS (1) arm and XIENCE V arm (3)) were excluded from the data analysis for acute success. During the index procedure, 5 subjects withdrew consent following randomization and before any device attempts. Data from these 5 subjects (3 in the Absorb BVS arm and 2 in the XIENCE V arm) were excluded from all data analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Acute Procedural Success | 230 Participants |
| XIENCE V EECSS | Number of Participants With Acute Procedural Success | 230 Participants |
Secondary
Number of Participants With Acute Stent/Scaffold 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: < or = 1 day
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS System | Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition) | Definite | 0 Participants |
| Absorb BVS System | Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition) | Probable | 0 Participants |
| XIENCE V EECSS | Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition) | Definite | 0 Participants |
| XIENCE V EECSS | Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition) | Probable | 0 Participants |
Secondary
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Coronary Revascularization (PCI and CABG) | 2 Participants |
| XIENCE V EECSS | Number of Participants With All Coronary Revascularization (PCI and CABG) | 1 Participants |
Secondary
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 0 to 298 Days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Coronary Revascularization (PCI and CABG) | 2 Participants |
| XIENCE V EECSS | Number of Participants With All Coronary Revascularization (PCI and CABG) | 2 Participants |
Secondary
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Coronary Revascularization (PCI and CABG) | 16 Participants |
| XIENCE V EECSS | Number of Participants With All Coronary Revascularization (PCI and CABG) | 17 Participants |
Secondary
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 2 year
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 System | Number of Participants With All Coronary Revascularization (PCI and CABG) | 21 Participants |
| XIENCE V EECSS | Number of Participants With All Coronary Revascularization (PCI and CABG) | 20 Participants |
Secondary
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 3 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Coronary Revascularization (PCI and CABG) | 24 Participants |
| XIENCE V EECSS | Number of Participants With All Coronary Revascularization (PCI and CABG) | 21 Participants |
Secondary
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 4 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Coronary Revascularization (PCI and CABG) | 27 Participants |
| XIENCE V EECSS | Number of Participants With All Coronary Revascularization (PCI and CABG) | 26 Participants |
Secondary
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Coronary Revascularization (PCI and CABG) | 1 Participants |
| XIENCE V EECSS | Number of Participants With All Coronary Revascularization (PCI and CABG) | 0 Participants |
Secondary
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 5 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Coronary Revascularization (PCI and CABG) | 28 Participants |
| XIENCE V EECSS | Number of Participants With All Coronary Revascularization (PCI and CABG) | 26 Participants |
Secondary
Number of Participants With All Coronary Revascularization (PCI and CABG)
All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Time frame: 0 to 37days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Coronary Revascularization (PCI and CABG) | 1 Participants |
| XIENCE V EECSS | Number of Participants With All Coronary Revascularization (PCI and CABG) | 0 Participants |
Secondary
Number of Participants With All 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Death/All MI/All Revascularization (DMR) | 26 Participants |
| XIENCE V EECSS | Number of Participants With All Death/All MI/All Revascularization (DMR) | 27 Participants |
Secondary
Number of Participants With All 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Death/All MI/All Revascularization (DMR) | 17 Participants |
| XIENCE V EECSS | Number of Participants With All Death/All MI/All Revascularization (DMR) | 22 Participants |
Secondary
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 2 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Death/All MI/All Revascularization (DMR) | 22 Participants |
| XIENCE V EECSS | Number of Participants With All Death/All MI/All Revascularization (DMR) | 26 Participants |
Secondary
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Death/All MI/All Revascularization (DMR) | 1 Participants |
| XIENCE V EECSS | Number of Participants With All Death/All MI/All Revascularization (DMR) | 2 Participants |
Secondary
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 0 to 298 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Death/All MI/All Revascularization (DMR) | 3 Participants |
| XIENCE V EECSS | Number of Participants With All Death/All MI/All Revascularization (DMR) | 8 Participants |
Secondary
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Death/All MI/All Revascularization (DMR) | 3 Participants |
| XIENCE V EECSS | Number of Participants With All Death/All MI/All Revascularization (DMR) | 7 Participants |
Secondary
Number of Participants With All Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 0 to 37 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Death/All MI/All Revascularization (DMR) | 2 Participants |
| XIENCE V EECSS | Number of Participants With All Death/All MI/All Revascularization (DMR) | 3 Participants |
Secondary
Number of Participants With All 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Death/All MI/All Revascularization (DMR) | 34 Participants |
| XIENCE V EECSS | Number of Participants With All Death/All MI/All Revascularization (DMR) | 34 Participants |
Secondary
Number of Participants With All 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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With All Death/All MI/All Revascularization (DMR) | 31 Participants |
| XIENCE V EECSS | Number of Participants With All Death/All MI/All Revascularization (DMR) | 34 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 3 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 5 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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: ≤ 7 days post index procedure (In-hospital )
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 1 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 2 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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: 0 to 37 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 2 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 3 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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: 0 to 298 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 3 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 5 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 7 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 9 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 10 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 11 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 13 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 11 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 16 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 13 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [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: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 17 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) | 13 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TVR [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: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 3 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 5 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TVR [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: 0 to 298 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 3 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 5 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TVR [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: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 8 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 13 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TVR [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: 2 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 11 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 15 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TVR [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: 3 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 14 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 15 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TVR [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: 4 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 18 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 19 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TVR [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: 5 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 19 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 19 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TVR [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: ≤ 7 days post index procedure (In-hospital)
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 1 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 2 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TVR [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: 0 to 37 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 2 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] | 3 Participants |
Secondary
Number of Participants With Cardiac Death/TV-MI/ID-TLR [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: 0 to 37 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 2 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 2 Participants |
Secondary
Number of Participants With Cardiac Death/TV-MI/ID-TLR [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: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 3 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 4 Participants |
Secondary
Number of Participants With Cardiac Death/TV-MI/ID-TLR [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: 0 to 298 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 3 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 5 Participants |
Secondary
Number of Participants With Cardiac Death/TV-MI/ID-TLR [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: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 7 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 9 Participants |
Secondary
Number of Participants With Cardiac Death/TV-MI/ID-TLR [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: 2 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 9 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 10 Participants |
Secondary
Number of Participants With Cardiac Death/TV-MI/ID-TLR [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: 3 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 12 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 10 Participants |
Secondary
Number of Participants With Cardiac Death/TV-MI/ID-TLR [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: 4 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 15 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 12 Participants |
Secondary
Number of Participants With Cardiac Death/TV-MI/ID-TLR [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: ≤ 7 days post index procedure (In-hospital )
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 1 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 2 Participants |
Secondary
Number of Participants With Cardiac Death/TV-MI/ID-TLR [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: 5 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 16 Participants |
| XIENCE V EECSS | Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] | 12 Participants |
Secondary
Number of Participants With Late Stent/Scaffold 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: 31 to 365 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS System | Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| Absorb BVS System | Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
| XIENCE V EECSS | Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| XIENCE V EECSS | Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
Secondary
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 0 to 298 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Myocardial Infarction | 2 Participants |
| XIENCE V EECSS | Number of Participants With Myocardial Infarction | 4 Participants |
Secondary
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 3 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Myocardial Infarction | 6 Participants |
| XIENCE V EECSS | Number of Participants With Myocardial Infarction | 5 Participants |
Secondary
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 4 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Myocardial Infarction | 7 Participants |
| XIENCE V EECSS | Number of Participants With Myocardial Infarction | 6 Participants |
Secondary
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 0 to 37 days
Population: Per-Treatment-Evaluable Population. Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Myocardial Infarction | 2 Participants |
| XIENCE V EECSS | Number of Participants With Myocardial Infarction | 3 Participants |
Secondary
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 5 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Myocardial Infarction | 7 Participants |
| XIENCE V EECSS | Number of Participants With Myocardial Infarction | 6 Participants |
Secondary
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Myocardial Infarction | 1 Participants |
| XIENCE V EECSS | Number of Participants With Myocardial Infarction | 2 Participants |
Secondary
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Myocardial Infarction | 2 Participants |
| XIENCE V EECSS | Number of Participants With Myocardial Infarction | 4 Participants |
Secondary
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Myocardial Infarction | 3 Participants |
| XIENCE V EECSS | Number of Participants With Myocardial Infarction | 4 Participants |
Secondary
Number of Participants With Myocardial Infarction
MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.
Time frame: 2 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Myocardial Infarction | 5 Participants |
| XIENCE V EECSS | Number of Participants With Myocardial Infarction | 5 Participants |
Secondary
Number of Participants With Subacute Stent/Scaffold 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: >1 to 30 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS System | Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| Absorb BVS System | Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 1 Participants |
| XIENCE V EECSS | Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| XIENCE V EECSS | Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 0 to 298 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Lesion Revascularization (TLR) | 2 Participants |
| XIENCE V EECSS | Number of Participants With Target Lesion Revascularization (TLR) | 1 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 5 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Lesion Revascularization (TLR) | 12 Participants |
| XIENCE V EECSS | Number of Participants With Target Lesion Revascularization (TLR) | 9 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 4 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Lesion Revascularization (TLR) | 12 Participants |
| XIENCE V EECSS | Number of Participants With Target Lesion Revascularization (TLR) | 9 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 3 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Lesion Revascularization (TLR) | 11 Participants |
| XIENCE V EECSS | Number of Participants With Target Lesion Revascularization (TLR) | 8 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 2 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Lesion Revascularization (TLR) | 9 Participants |
| XIENCE V EECSS | Number of Participants With Target Lesion Revascularization (TLR) | 8 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Lesion Revascularization (TLR) | 7 Participants |
| XIENCE V EECSS | Number of Participants With Target Lesion Revascularization (TLR) | 7 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Lesion Revascularization (TLR) | 2 Participants |
| XIENCE V EECSS | Number of Participants With Target Lesion Revascularization (TLR) | 4 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: 0 to 37 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Lesion Revascularization (TLR) | 1 Participants |
| XIENCE V EECSS | Number of Participants With Target Lesion Revascularization (TLR) | 0 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Lesion Revascularization (TLR) | 1 Participants |
| XIENCE V EECSS | Number of Participants With Target Lesion Revascularization (TLR) | 0 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 0 to 37 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Vessel Revascularization (TVR) | 1 Participants |
| XIENCE V EECSS | Number of Participants With Target Vessel Revascularization (TVR) | 0 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 0 to 208 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Vessel Revascularization (TVR) | 2 Participants |
| XIENCE V EECSS | Number of Participants With Target Vessel Revascularization (TVR) | 1 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 0 to 298 days
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Vessel Revascularization (TVR) | 2 Participants |
| XIENCE V EECSS | Number of Participants With Target Vessel Revascularization (TVR) | 1 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Vessel Revascularization (TVR) | 9 Participants |
| XIENCE V EECSS | Number of Participants With Target Vessel Revascularization (TVR) | 12 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 2 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Vessel Revascularization (TVR) | 11 Participants |
| XIENCE V EECSS | Number of Participants With Target Vessel Revascularization (TVR) | 13 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Vessel Revascularization (TVR) | 1 Participants |
| XIENCE V EECSS | Number of Participants With Target Vessel Revascularization (TVR) | 0 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 3 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Vessel Revascularization (TVR) | 14 Participants |
| XIENCE V EECSS | Number of Participants With Target Vessel Revascularization (TVR) | 13 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 4 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Vessel Revascularization (TVR) | 16 Participants |
| XIENCE V EECSS | Number of Participants With Target Vessel Revascularization (TVR) | 16 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)
Time frame: 5 years
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS System | Number of Participants With Target Vessel Revascularization (TVR) | 16 Participants |
| XIENCE V EECSS | Number of Participants With Target Vessel Revascularization (TVR) | 16 Participants |
Secondary
Number of Participants With Very Late 1 to 2 Year Stent/Scaffold 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: 366 to 730 days
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 System | Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 1 Participants |
| Absorb BVS System | Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
Secondary
Number of Participants With Very Late 1 to 3 Year Stent/Scaffold 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: 366-1095 days
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 System | Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 1 Participants |
| Absorb BVS System | Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
Secondary
Number of Participants With Very Late 2 to 3 Year Stent/Scaffold 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: 731 to 1095 days
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 System | Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| Absorb BVS System | Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
Secondary
Number of Participants With Very Late 3 to 4 Year Stent/Scaffold 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: 1096-1460 days
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 System | Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| Absorb BVS System | Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 1 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 1 Participants |
Secondary
Number of Participants With Very Late 3 to 5 Year Stent/Scaffold 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: 1096-1825 days
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 System | Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| Absorb BVS System | Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 1 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 1 Participants |
Secondary
Number of Participants With Very Late 4 to 5 Year Stent/Scaffold 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: 1461-1825 days
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 System | Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| Absorb BVS System | Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Definite | 0 Participants |
| XIENCE V EECSS | Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) | Probable | 0 Participants |
Secondary
Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis
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: 0-1825 days
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 System | Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis | Definite | 1 Participants |
| Absorb BVS System | Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis | Probable | 2 Participants |
| XIENCE V EECSS | Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis | Definite | 0 Participants |
| XIENCE V EECSS | Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis | Probable | 1 Participants |
Secondary
Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)
Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb BVS System | Percentage of Participants With Distal Angiographic Binary Restenosis (ABR) | 0.0 Percentage of participants |
| XIENCE V EECSS | Percentage of Participants With Distal Angiographic Binary Restenosis (ABR) | 1.0 Percentage of participants |
Secondary
Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)
Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb BVS System | Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR) | 3.3 Percentage of participants |
| XIENCE V EECSS | Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR) | 1.0 Percentage of participants |
Secondary
Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)
Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb BVS System | Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR) | 4.2 percentage of participants |
| XIENCE V EECSS | Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR) | 2.9 percentage of participants |
Secondary
Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)
Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb BVS System | Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR) | 1.0 Percentage of participants |
| XIENCE V EECSS | Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR) | 1.5 Percentage of participants |
Secondary
Proximal Late Loss (LL)
Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup. Proximal is defined as within 5 mm of healthy tissue proximal to the device placement.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | Proximal Late Loss (LL) | 0.19 Millimeter | Standard Deviation 0.39 |
| XIENCE V EECSS | Proximal Late Loss (LL) | 0.13 Millimeter | Standard Deviation 0.42 |
Secondary
Proximal Minimum Lumen Diameter (MLD)
Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.
Time frame: 1 year
Population: Per-Treatment-Evaluable Population (PTE) Population. Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | Proximal Minimum Lumen Diameter (MLD) | 2.64 Millimeter | Standard Deviation 0.48 |
| XIENCE V EECSS | Proximal Minimum Lumen Diameter (MLD) | 2.68 Millimeter | Standard Deviation 0.56 |
Secondary
Proximal Percent Diameter Stenosis (%DS)
The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.
Time frame: 1 year
Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS System | Proximal Percent Diameter Stenosis (%DS) | 11.09 Percent Diameter stenosis | Standard Deviation 10.13 |
| XIENCE V EECSS | Proximal Percent Diameter Stenosis (%DS) | 12.12 Percent Diameter stenosis | Standard Deviation 11.63 |