Coronary Artery Disease
Conditions
Keywords
Bioabsorbable, Coronary scaffold, Coronary Stent, Everolimus, Drug eluting stents, Angioplasty, Coronary artery disease, Total coronary occlusion, Coronary artery restenosis, Stent thrombosis, Myocardial ischemia, Coronary artery stenosis
Brief summary
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)
Detailed description
In the USA, ABSORB BVS is currently in development at Abbott Vascular. Not available for sale in the US.
Interventions
XIENCE implantation in the treatment of coronary artery disease.
ABSORB BVS implantation in the treatment of coronary artery disease.
Sponsors
Study design
Eligibility
Inclusion criteria
General Inclusion Criteria * Subject must be at least 18 years of age and less than 85 years of age. * Subject must agree not to participate in any other clinical investigation for a period of three years following the index procedure. This includes clinical trials of medication and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed. * Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS system and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee. * Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia). * Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery * Subject must agree to undergo all clinical investigation plan-required follow-up visits, exercise testing, blood draw as well as adherence to European Society of Cardiology Guidelines and completion of quality of life questionnaires and of a subject diary to collect information including but not limited to tobacco usage, food intake, daily exercise and body weight Angiographic Inclusion Criteria * One or two de novo native lesions each located in a different epicardial vessel. * If two treatable lesions meet the eligibility criteria, they must be in separate major epicardial vessels (left anterior descending (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches). * Lesion(s) must have a visually estimated diameter stenosis of ≥50% and \<100% with a TIMI flow of ≥1. * Lesion(s) must be located in a native coronary artery with Dmax by on-line quantitative coronary angiography (QCA) of ≥2.25 mm and ≤3.8 mm. * Lesion(s) must be located in a native coronary artery with lesion(s) length by on-line QCA of ≤48 mm. * Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥30 days prior to or if planned to be done 2 years after the index procedure. * Percutaneous intervention for lesions in the target vessel are allowed if done \>6 months prior to or if planned to be done 2 years after the index procedure.
Exclusion criteria
* Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and prasugrel and ticlopidine, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. * Subject has a known diagnosis of acute myocardial infarction (AMI) at any time preceding the index procedure and relevant cardiac enzymes (according to local standard hospital practice) have not returned within normal limits at the time of procedure. * Evidence of ongoing acute myocardial infarction in ECG prior to procedure * Subject has current unstable arrhythmias. * Left ventricular ejection fraction (LVEF) \< 30%. * Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant. * Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure. * Subject is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.). * Subject is receiving chronic anticoagulation therapy that can not be stopped and restarted according to local hospital standard procedures. * Elective surgery is planned within 2 years after the procedure that will require discontinuing either aspirin, clopidogrel, prasugrel or ticlopidine. * Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, a white blood cell count of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) * Known renal insufficiency (e.g., estimated glomerular filtration rate \<60 ml/kg/1.73m² or serum creatinine level of \>2.5 mg/dL, or subject on dialysis). * History of bleeding diathesis or coagulopathy or will refuse blood transfusions. * Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past 6 months. * Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial) * Other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy. * Subject is already participating in another clinical investigation that has not yet reached its primary endpoint. * Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD) | 3 years | In-scaffold:Within the margins of the scaffold. |
| Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter | 3 years | In-scaffold:Within the margins of the scaffold. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | In-hospital (≤ 7 days of post index procedure) | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * 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 All Myocardial Infarction (Per Protocol Definition) | In-hospital (≤ 7 days of post index procedure) | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves. |
| Number of Participants With Target Lesion Revascularization (TLR) | In-hospital (≤ 7 days of post index procedure) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. |
| Number of Participants With Target Vessel Revascularization (TVR) | In-hospital (≤ 7 days of post index procedure) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. |
| Number of Participants With Non Target Vessel Revascularization (Non-TVR) | In-hospital (≤ 7 days of post index procedure) | Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel. |
| Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | 5 years | Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel. |
| Number of Participants With All Revascularization | In-hospital (≤ 7 days of post index procedure) | Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel. |
| Number of Participants Experiencing All Death/All MI | In-hospital (≤ 7 days of post index procedure) | All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. |
| Number of Participants With Target Lesion Failure (TLF) (Cardiac Death,(Target Vessel Myocardial Infarction(TV-MI), ID-TLR) | In-hospital (≤ 7 days of post index procedure) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), ID-TLR) | 30 days | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Device Success | From the start of index procedure to end of index procedure | Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA). |
| Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | In-hospital (≤ 7 days of post index procedure) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
| Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | In-hospital (≤ 7 days of post index procedure) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
| Number of Participants With DMR (All Death, All MI, All Revascularization) | In-hospital (≤ 7 days of post index procedure) | DMR is the composite of All Death, All MI, All Revascularization |
| Number of Participants Experiencing Cardiac Death/All MI | In-hospital (≤ 7 days of post index procedure) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves |
| Number of Participants With Acute Stent/Scaffold Thrombosis | <=1 day | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause. |
| Number of Participants With Subacute Stent/Scaffold Thrombosis | > 1-30 days | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause. |
| Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis | 0-30 days | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause. |
| Number of Participants With Late Stent/Scaffold Thrombosis | 31-365 days | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause. |
| Number of Participants With Very Late Stent/Scaffold Thrombosis | > 365 days | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause. |
| Number of Participants With Cumulative Stent/Scaffold Thrombosis | 0-1853 days | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause. |
| Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 180 days | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Number of Participants With Procedural Success | From the start of index procedure to end of index procedure | Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay. |
Countries
Belgium
Participant flow
Recruitment details
A total of 501 patients (335 participants in the Absorb arm and 166 subjects in the XIENCE arm) were randomized into the ABSORB II Randomized controlled trial (RCT) at 46 international outside the United States (OUS) sites study sites. First subject was randomized on 28 November 2011 and the last subject randomized on 04 June 2013.
Pre-assignment details
Early termination by 5-year affected 120 patients due to subject withdrew consent (n=20), withdrawn by the site (n=1), lost to follow-up (n=9), death (n=20),early termination due to a lapse in the protocol renewal by the Polish Ethics Committee (n=37) and early terminations due to 'other' reasons (n=33).
Participants by arm
| Arm | Count |
|---|---|
| Absorb BVS™ Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease. | 335 |
| XIENCE™ Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease. | 166 |
| Total | 501 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| At 180-day Clinical Follow-up | Death | 0 | 1 |
| At 180-day Clinical Follow-up | Withdrawal by Subject | 3 | 0 |
| At 1-year Clinical Follow-up | Withdrawal by Physician/Site | 1 | 0 |
| At 1-year Clinical Follow-up | Withdrawal by Subject | 1 | 1 |
| At 2-year Clinical Follow-up | Death | 2 | 0 |
| At 2-year Clinical Follow-up | Lost to Follow-up | 1 | 0 |
| At 2-year Clinical Follow-up | Patient did not want to participate in t | 1 | 0 |
| At 2-year Clinical Follow-up | Withdrawal by Subject | 2 | 1 |
| At 30-day Clinical Follow-up | Withdrawal by Subject | 1 | 0 |
| At 3-year Clinical Follow-up | Death | 2 | 3 |
| At 3-year Clinical Follow-up | Withdrawal by Subject | 3 | 3 |
| At 4-year Clinical Follow-up | Death | 7 | 3 |
| At 4-year Clinical Follow-up | Did not consent for follow-up after 3 ye | 10 | 10 |
| At 4-year Clinical Follow-up | Lost to Follow-up | 4 | 1 |
| At 4-year Clinical Follow-up | Terminated by Polish Ethics Committee | 6 | 5 |
| At 4-year Clinical Follow-up | Withdrawal by Subject | 3 | 2 |
| At 5-year Clinical Follow-up | Death | 2 | 0 |
| At 5-year Clinical Follow-up | Lost to Follow-up | 2 | 1 |
| At 5-year Clinical Follow-up | Refused/terminated | 9 | 3 |
| At 5-year Clinical Follow-up | Terminated by Polish Ethics Committee | 19 | 7 |
Baseline characteristics
| Characteristic | Absorb BVS™ | XIENCE™ | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 133 Participants | 64 Participants | 197 Participants |
| Age, Categorical Between 18 and 65 years | 202 Participants | 102 Participants | 304 Participants |
| Age, Continuous | 61.5 years STANDARD_DEVIATION 10 | 60.9 years STANDARD_DEVIATION 10 | 61.3 years STANDARD_DEVIATION 10 |
| Region of Enrollment Austria | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment Belgium | 6 Participants | 0 Participants | 6 Participants |
| Region of Enrollment Denmark | 11 Participants | 5 Participants | 16 Participants |
| Region of Enrollment France | 51 Participants | 25 Participants | 76 Participants |
| Region of Enrollment Germany | 14 Participants | 6 Participants | 20 Participants |
| Region of Enrollment Israel | 8 Participants | 4 Participants | 12 Participants |
| Region of Enrollment Italy | 33 Participants | 13 Participants | 46 Participants |
| Region of Enrollment Netherlands | 48 Participants | 34 Participants | 82 Participants |
| Region of Enrollment New Zealand | 15 Participants | 8 Participants | 23 Participants |
| Region of Enrollment Poland | 26 Participants | 16 Participants | 42 Participants |
| Region of Enrollment Portugal | 11 Participants | 2 Participants | 13 Participants |
| Region of Enrollment Spain | 63 Participants | 28 Participants | 91 Participants |
| Region of Enrollment Switzerland | 8 Participants | 4 Participants | 12 Participants |
| Region of Enrollment United Kingdom | 37 Participants | 17 Participants | 54 Participants |
| Sex: Female, Male Female | 82 Participants | 34 Participants | 116 Participants |
| Sex: Female, Male Male | 253 Participants | 132 Participants | 385 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 138 | 13 / 285 |
| other Total, other adverse events | 151 / 159 | 296 / 318 |
| serious Total, serious adverse events | 84 / 159 | 165 / 318 |
Outcome results
Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)
In-scaffold:Within the margins of the scaffold.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS™ | Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD) | 0.05 mm | Standard Deviation 0.11 |
| XIENCE™ | Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD) | 0.06 mm | Standard Deviation 0.12 |
Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter
In-scaffold:Within the margins of the scaffold.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absorb BVS™ | Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter | -0.37 mm | Standard Deviation 0.45 |
| XIENCE™ | Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter | -0.25 mm | Standard Deviation 0.25 |
Device Success
Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).
Time frame: From the start of index procedure to end of index procedure
Population: Device Success is measured on a per Lesion basis. Some patients had more than one lesion treated so the total number of lesions is larger than the number of patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absorb BVS™ | Device Success | 99.5 Percentage of lesions |
| XIENCE™ | Device Success | 100 Percentage of lesions |
Number of Participants Experiencing All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) * Q wave MI Development of new, pathological Q wave on the ECG. * Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death/All MI | 37 Participants |
| XIENCE™ | Number of Participants Experiencing All Death/All MI | 13 Participants |
Number of Participants Experiencing All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death/All MI | 13 Participants |
| XIENCE™ | Number of Participants Experiencing All Death/All MI | 2 Participants |
Number of Participants Experiencing All Death/All MI
All deaths includes • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) * Q wave MI Development of new, pathological Q wave on the ECG. * Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death/All MI | 14 Participants |
| XIENCE™ | Number of Participants Experiencing All Death/All MI | 2 Participants |
Number of Participants Experiencing All Death/All MI
All deaths includes • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) * Q wave MI Development of new, pathological Q wave on the ECG. * Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death/All MI | 14 Participants |
| XIENCE™ | Number of Participants Experiencing All Death/All MI | 3 Participants |
Number of Participants Experiencing All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death/All MI | 15 Participants |
| XIENCE™ | Number of Participants Experiencing All Death/All MI | 3 Participants |
Number of Participants Experiencing All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed 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: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death/All MI | 22 Participants |
| XIENCE™ | Number of Participants Experiencing All Death/All MI | 5 Participants |
Number of Participants Experiencing All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed 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: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death/All MI | 33 Participants |
| XIENCE™ | Number of Participants Experiencing All Death/All MI | 11 Participants |
Number of Participants Experiencing All Death/All MI
All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed 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: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death/All MI | 35 Participants |
| XIENCE™ | Number of Participants Experiencing All Death/All MI | 12 Participants |
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * 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: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 11 Participants |
| XIENCE™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 7 Participants |
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * 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: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 13 Participants |
| XIENCE™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 7 Participants |
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * 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: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 0 Participants |
| XIENCE™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 0 Participants |
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 0 Participants |
| XIENCE™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 0 Participants |
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: 180 Days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 0 Participants |
| XIENCE™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 1 Participants |
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 0 Participants |
| XIENCE™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 1 Participants |
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 4 Participants |
| XIENCE™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 1 Participants |
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 8 Participants |
| XIENCE™ | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | 6 Participants |
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing Cardiac Death/All MI | 14 Participants |
| XIENCE™ | Number of Participants Experiencing Cardiac Death/All MI | 2 Participants |
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing Cardiac Death/All MI | 29 Participants |
| XIENCE™ | Number of Participants Experiencing Cardiac Death/All MI | 10 Participants |
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing Cardiac Death/All MI | 29 Participants |
| XIENCE™ | Number of Participants Experiencing Cardiac Death/All MI | 9 Participants |
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing Cardiac Death/All MI | 28 Participants |
| XIENCE™ | Number of Participants Experiencing Cardiac Death/All MI | 8 Participants |
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing Cardiac Death/All MI | 20 Participants |
| XIENCE™ | Number of Participants Experiencing Cardiac Death/All MI | 4 Participants |
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing Cardiac Death/All MI | 15 Participants |
| XIENCE™ | Number of Participants Experiencing Cardiac Death/All MI | 2 Participants |
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing Cardiac Death/All MI | 14 Participants |
| XIENCE™ | Number of Participants Experiencing Cardiac Death/All MI | 2 Participants |
Number of Participants Experiencing Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants Experiencing Cardiac Death/All MI | 13 Participants |
| XIENCE™ | Number of Participants Experiencing Cardiac Death/All MI | 2 Participants |
Number of Participants With Acute Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time frame: <=1 day
Population: ITT population. .
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS™ | Number of Participants With Acute Stent/Scaffold Thrombosis | Definite | 1 Participants |
| Absorb BVS™ | Number of Participants With Acute Stent/Scaffold Thrombosis | Probable | 0 Participants |
| XIENCE™ | Number of Participants With Acute Stent/Scaffold Thrombosis | Definite | 0 Participants |
| XIENCE™ | Number of Participants With Acute Stent/Scaffold Thrombosis | Probable | 0 Participants |
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time frame: 0-30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS™ | Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis | Definite | 2 Participants |
| Absorb BVS™ | Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis | Probable | 0 Participants |
| XIENCE™ | Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis | Definite | 0 Participants |
| XIENCE™ | Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis | Probable | 0 Participants |
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 27 Participants |
| XIENCE™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 5 Participants |
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 27 Participants |
| XIENCE™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 5 Participants |
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 19 Participants |
| XIENCE™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 4 Participants |
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 15 Participants |
| XIENCE™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 2 Participants |
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 14 Participants |
| XIENCE™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 2 Participants |
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves.
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 14 Participants |
| XIENCE™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 2 Participants |
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves.
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 13 Participants |
| XIENCE™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 2 Participants |
Number of Participants With All Myocardial Infarction (Per Protocol Definition)
Myocardial Infarction (MI) * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 27 Participants |
| XIENCE™ | Number of Participants With All Myocardial Infarction (Per Protocol Definition) | 6 Participants |
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Revascularization | 12 Participants |
| XIENCE™ | Number of Participants With All Revascularization | 12 Participants |
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Revascularization | 7 Participants |
| XIENCE™ | Number of Participants With All Revascularization | 6 Participants |
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Revascularization | 2 Participants |
| XIENCE™ | Number of Participants With All Revascularization | 2 Participants |
Number of Participants With All Revascularization
Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Revascularization | 59 Participants |
| XIENCE™ | Number of Participants With All Revascularization | 34 Participants |
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Revascularization | 57 Participants |
| XIENCE™ | Number of Participants With All Revascularization | 34 Participants |
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Revascularization | 49 Participants |
| XIENCE™ | Number of Participants With All Revascularization | 33 Participants |
Number of Participants With All Revascularization
Revascularization: * Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Revascularization | 22 Participants |
| XIENCE™ | Number of Participants With All Revascularization | 18 Participants |
Number of Participants With All Revascularization
Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With All Revascularization | 1 Participants |
| XIENCE™ | Number of Participants With All Revascularization | 0 Participants |
Number of Participants With Cumulative Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time frame: 0-1853 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS™ | Number of Participants With Cumulative Stent/Scaffold Thrombosis | Definite | 8 Participants |
| Absorb BVS™ | Number of Participants With Cumulative Stent/Scaffold Thrombosis | Probable | 1 Participants |
| XIENCE™ | Number of Participants With Cumulative Stent/Scaffold Thrombosis | Definite | 0 Participants |
| XIENCE™ | Number of Participants With Cumulative Stent/Scaffold Thrombosis | Probable | 0 Participants |
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 76 Participants |
| XIENCE™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 40 Participants |
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 80 Participants |
| XIENCE™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 41 Participants |
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization.
Time frame: 1 year
Population: Intent-to-Treat Population (ITT).The number of participants analyzed include subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 24 Participants |
| XIENCE™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 15 Participants |
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization.
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 19 Participants |
| XIENCE™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 9 Participants |
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization.
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 14 Participants |
| XIENCE™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 4 Participants |
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 13 Participants |
| XIENCE™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 2 Participants |
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization.
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 38 Participants |
| XIENCE™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 21 Participants |
Number of Participants With DMR (All Death, All MI, All Revascularization)
DMR is the composite of All Death, All MI, All Revascularization.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 68 Participants |
| XIENCE™ | Number of Participants With DMR (All Death, All MI, All Revascularization) | 39 Participants |
Number of Participants With Late Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time frame: 31-365 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS™ | Number of Participants With Late Stent/Scaffold Thrombosis | Definite | 0 Participants |
| Absorb BVS™ | Number of Participants With Late Stent/Scaffold Thrombosis | Probable | 1 Participants |
| XIENCE™ | Number of Participants With Late Stent/Scaffold Thrombosis | Definite | 0 Participants |
| XIENCE™ | Number of Participants With Late Stent/Scaffold Thrombosis | Probable | 0 Participants |
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 38 Participants |
| XIENCE™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 11 Participants |
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 41 Participants |
| XIENCE™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 13 Participants |
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 17 Participants |
| XIENCE™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 5 Participants |
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 13 Participants |
| XIENCE™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 2 Participants |
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 14 Participants |
| XIENCE™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 2 Participants |
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 14 Participants |
| XIENCE™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 3 Participants |
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 25 Participants |
| XIENCE™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 7 Participants |
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 40 Participants |
| XIENCE™ | Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) | 12 Participants |
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 0 Participants |
| XIENCE™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 0 Participants |
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 22 Participants |
| XIENCE™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 19 Participants |
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 10 Participants |
| XIENCE™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 11 Participants |
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 29 Participants |
| XIENCE™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 20 Participants |
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 1 Participants |
| XIENCE™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 0 Participants |
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 6 Participants |
| XIENCE™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 6 Participants |
Number of Participants With Non Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 4 Participants |
| XIENCE™ | Number of Participants With Non Target Vessel Revascularization (Non-TVR) | 3 Participants |
Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | 30 Participants |
| XIENCE™ | Number of Participants With Non-Target Vessel Revascularization (Non-TVR) | 20 Participants |
Number of Participants With Procedural Success
Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay.
Time frame: From the start of index procedure to end of index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Procedural Success | 322 Participants |
| XIENCE™ | Number of Participants With Procedural Success | 164 Participants |
Number of Participants With Subacute Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time frame: > 1-30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS™ | Number of Participants With Subacute Stent/Scaffold Thrombosis | Definite | 1 Participants |
| Absorb BVS™ | Number of Participants With Subacute Stent/Scaffold Thrombosis | Probable | 0 Participants |
| XIENCE™ | Number of Participants With Subacute Stent/Scaffold Thrombosis | Definite | 0 Participants |
| XIENCE™ | Number of Participants With Subacute Stent/Scaffold Thrombosis | Probable | 0 Participants |
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), ID-TLR) | 13 Participants |
| XIENCE™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), ID-TLR) | 2 Participants |
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death,(Target Vessel Myocardial Infarction(TV-MI), ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death,(Target Vessel Myocardial Infarction(TV-MI), ID-TLR) | 12 Participants |
| XIENCE™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death,(Target Vessel Myocardial Infarction(TV-MI), ID-TLR) | 2 Participants |
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 38 Participants |
| XIENCE™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 9 Participants |
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 13 Participants |
| XIENCE™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 3 Participants |
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 16 Participants |
| XIENCE™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 5 Participants |
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 23 Participants |
| XIENCE™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 5 Participants |
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 34 Participants |
| XIENCE™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 8 Participants |
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 37 Participants |
| XIENCE™ | Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) | 9 Participants |
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Revascularization (TLR) | 2 Participants |
| XIENCE™ | Number of Participants With Target Lesion Revascularization (TLR) | 0 Participants |
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Revascularization (TLR) | 2 Participants |
| XIENCE™ | Number of Participants With Target Lesion Revascularization (TLR) | 1 Participants |
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Revascularization (TLR) | 4 Participants |
| XIENCE™ | Number of Participants With Target Lesion Revascularization (TLR) | 3 Participants |
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Revascularization (TLR) | 9 Participants |
| XIENCE™ | Number of Participants With Target Lesion Revascularization (TLR) | 3 Participants |
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Revascularization (TLR) | 28 Participants |
| XIENCE™ | Number of Participants With Target Lesion Revascularization (TLR) | 8 Participants |
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Revascularization (TLR) | 27 Participants |
| XIENCE™ | Number of Participants With Target Lesion Revascularization (TLR) | 8 Participants |
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Revascularization (TLR) | 24 Participants |
| XIENCE™ | Number of Participants With Target Lesion Revascularization (TLR) | 8 Participants |
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Lesion Revascularization (TLR) | 1 Participants |
| XIENCE™ | Number of Participants With Target Lesion Revascularization (TLR) | 0 Participants |
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 47 Participants |
| XIENCE™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 22 Participants |
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 41 Participants |
| XIENCE™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 20 Participants |
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 45 Participants |
| XIENCE™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 21 Participants |
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 18 Participants |
| XIENCE™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 8 Participants |
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 15 Participants |
| XIENCE™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 5 Participants |
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 14 Participants |
| XIENCE™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 3 Participants |
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 13 Participants |
| XIENCE™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 2 Participants |
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 28 Participants |
| XIENCE™ | Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) | 11 Participants |
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: In-hospital (≤ 7 days of post index procedure)
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Revascularization (TVR) | 1 Participants |
| XIENCE™ | Number of Participants With Target Vessel Revascularization (TVR) | 0 Participants |
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 1 year
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Revascularization (TVR) | 8 Participants |
| XIENCE™ | Number of Participants With Target Vessel Revascularization (TVR) | 8 Participants |
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 180 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Revascularization (TVR) | 4 Participants |
| XIENCE™ | Number of Participants With Target Vessel Revascularization (TVR) | 4 Participants |
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Revascularization (TVR) | 2 Participants |
| XIENCE™ | Number of Participants With Target Vessel Revascularization (TVR) | 2 Participants |
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Revascularization (TVR) | 33 Participants |
| XIENCE™ | Number of Participants With Target Vessel Revascularization (TVR) | 19 Participants |
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 4 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Revascularization (TVR) | 38 Participants |
| XIENCE™ | Number of Participants With Target Vessel Revascularization (TVR) | 19 Participants |
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 5 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Revascularization (TVR) | 41 Participants |
| XIENCE™ | Number of Participants With Target Vessel Revascularization (TVR) | 19 Participants |
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Absorb BVS™ | Number of Participants With Target Vessel Revascularization (TVR) | 15 Participants |
| XIENCE™ | Number of Participants With Target Vessel Revascularization (TVR) | 9 Participants |
Number of Participants With Very Late Stent/Scaffold Thrombosis
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points. Timings: Acute:0-24 hours;Subacute:\>24 hours-30 days;Late:30 days-1 year;Very late:\>1 year. Definite stent thrombosis occurred by either angiographic/pathologic confirmation. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus Pathological confirmation:Evidence of recent thrombus. Probable stent thrombosis may occur after intracoronary stenting due to: * Unexplained death within first 30 days * Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time frame: > 365 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Absorb BVS™ | Number of Participants With Very Late Stent/Scaffold Thrombosis | Definite | 6 Participants |
| Absorb BVS™ | Number of Participants With Very Late Stent/Scaffold Thrombosis | Probable | 0 Participants |
| XIENCE™ | Number of Participants With Very Late Stent/Scaffold Thrombosis | Definite | 0 Participants |
| XIENCE™ | Number of Participants With Very Late Stent/Scaffold Thrombosis | Probable | 0 Participants |