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ABSORB II Randomized Controlled Trial

ABSORB II RANDOMIZED CONTROLLED TRIAL A Clinical Evaluation to Compare the Safety, Efficacy and Performance of ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System Against XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by de Novo Native Coronary Artery Lesions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01425281
Acronym
ABSORB II
Enrollment
501
Registered
2011-08-30
Start date
2011-11-30
Completion date
2018-05-23
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

DEVICEAbbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System

ABSORB BVS implantation in the treatment of coronary artery disease.

Sponsors

Abbott Medical Devices
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)3 yearsIn-scaffold:Within the margins of the scaffold.
Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter3 yearsIn-scaffold:Within the margins of the scaffold.

Secondary

MeasureTime frameDescription
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 yearsNon Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.
Number of Participants With All RevascularizationIn-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 MIIn-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 daysTarget Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Device SuccessFrom the start of index procedure to end of index procedureSuccessful 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 MIIn-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 dayScaffold/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 daysScaffold/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 Thrombosis0-30 daysScaffold/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 Thrombosis31-365 daysScaffold/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 daysScaffold/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 Thrombosis0-1853 daysScaffold/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 daysTarget 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 SuccessFrom the start of index procedure to end of index procedureAchievement 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

ArmCount
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
Total501

Withdrawals & dropouts

PeriodReasonFG000FG001
At 180-day Clinical Follow-upDeath01
At 180-day Clinical Follow-upWithdrawal by Subject30
At 1-year Clinical Follow-upWithdrawal by Physician/Site10
At 1-year Clinical Follow-upWithdrawal by Subject11
At 2-year Clinical Follow-upDeath20
At 2-year Clinical Follow-upLost to Follow-up10
At 2-year Clinical Follow-upPatient did not want to participate in t10
At 2-year Clinical Follow-upWithdrawal by Subject21
At 30-day Clinical Follow-upWithdrawal by Subject10
At 3-year Clinical Follow-upDeath23
At 3-year Clinical Follow-upWithdrawal by Subject33
At 4-year Clinical Follow-upDeath73
At 4-year Clinical Follow-upDid not consent for follow-up after 3 ye1010
At 4-year Clinical Follow-upLost to Follow-up41
At 4-year Clinical Follow-upTerminated by Polish Ethics Committee65
At 4-year Clinical Follow-upWithdrawal by Subject32
At 5-year Clinical Follow-upDeath20
At 5-year Clinical Follow-upLost to Follow-up21
At 5-year Clinical Follow-upRefused/terminated93
At 5-year Clinical Follow-upTerminated by Polish Ethics Committee197

Baseline characteristics

CharacteristicAbsorb BVS™XIENCE™Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
133 Participants64 Participants197 Participants
Age, Categorical
Between 18 and 65 years
202 Participants102 Participants304 Participants
Age, Continuous61.5 years
STANDARD_DEVIATION 10
60.9 years
STANDARD_DEVIATION 10
61.3 years
STANDARD_DEVIATION 10
Region of Enrollment
Austria
4 Participants4 Participants8 Participants
Region of Enrollment
Belgium
6 Participants0 Participants6 Participants
Region of Enrollment
Denmark
11 Participants5 Participants16 Participants
Region of Enrollment
France
51 Participants25 Participants76 Participants
Region of Enrollment
Germany
14 Participants6 Participants20 Participants
Region of Enrollment
Israel
8 Participants4 Participants12 Participants
Region of Enrollment
Italy
33 Participants13 Participants46 Participants
Region of Enrollment
Netherlands
48 Participants34 Participants82 Participants
Region of Enrollment
New Zealand
15 Participants8 Participants23 Participants
Region of Enrollment
Poland
26 Participants16 Participants42 Participants
Region of Enrollment
Portugal
11 Participants2 Participants13 Participants
Region of Enrollment
Spain
63 Participants28 Participants91 Participants
Region of Enrollment
Switzerland
8 Participants4 Participants12 Participants
Region of Enrollment
United Kingdom
37 Participants17 Participants54 Participants
Sex: Female, Male
Female
82 Participants34 Participants116 Participants
Sex: Female, Male
Male
253 Participants132 Participants385 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
7 / 13813 / 285
other
Total, other adverse events
151 / 159296 / 318
serious
Total, serious adverse events
84 / 159165 / 318

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Absorb BVS™Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)0.05 mmStandard Deviation 0.11
XIENCE™Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)0.06 mmStandard Deviation 0.12
Comparison: Angiographic vasomotion reactivity following nitrate administration, the test was analyzable for 388 paired lesions (Absorb arm \[258 lesions\] vs Xience arm \[130 lesions\]).p-value: 0.49t-test, 2 sided
Primary

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

ArmMeasureValue (MEAN)Dispersion
Absorb BVS™Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter-0.37 mmStandard Deviation 0.45
XIENCE™Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter-0.25 mmStandard Deviation 0.25
Comparison: Follow-up angiographic analysis was available for 298 lesions in the Absorb arm and 151 lesions in the Xience arm.p-value: 0.78t-test, 2 sided
Secondary

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.

ArmMeasureValue (NUMBER)
Absorb BVS™Device Success99.5 Percentage of lesions
XIENCE™Device Success100 Percentage of lesions
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing All Death/All MI37 Participants
XIENCE™Number of Participants Experiencing All Death/All MI13 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing All Death/All MI13 Participants
XIENCE™Number of Participants Experiencing All Death/All MI2 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing All Death/All MI14 Participants
XIENCE™Number of Participants Experiencing All Death/All MI2 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing All Death/All MI14 Participants
XIENCE™Number of Participants Experiencing All Death/All MI3 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing All Death/All MI15 Participants
XIENCE™Number of Participants Experiencing All Death/All MI3 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing All Death/All MI22 Participants
XIENCE™Number of Participants Experiencing All Death/All MI5 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing All Death/All MI33 Participants
XIENCE™Number of Participants Experiencing All Death/All MI11 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing All Death/All MI35 Participants
XIENCE™Number of Participants Experiencing All Death/All MI12 Participants
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing Cardiac Death/All MI14 Participants
XIENCE™Number of Participants Experiencing Cardiac Death/All MI2 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing Cardiac Death/All MI29 Participants
XIENCE™Number of Participants Experiencing Cardiac Death/All MI10 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing Cardiac Death/All MI29 Participants
XIENCE™Number of Participants Experiencing Cardiac Death/All MI9 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing Cardiac Death/All MI28 Participants
XIENCE™Number of Participants Experiencing Cardiac Death/All MI8 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing Cardiac Death/All MI20 Participants
XIENCE™Number of Participants Experiencing Cardiac Death/All MI4 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing Cardiac Death/All MI15 Participants
XIENCE™Number of Participants Experiencing Cardiac Death/All MI2 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing Cardiac Death/All MI14 Participants
XIENCE™Number of Participants Experiencing Cardiac Death/All MI2 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants Experiencing Cardiac Death/All MI13 Participants
XIENCE™Number of Participants Experiencing Cardiac Death/All MI2 Participants
Secondary

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. .

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With Acute Stent/Scaffold ThrombosisDefinite1 Participants
Absorb BVS™Number of Participants With Acute Stent/Scaffold ThrombosisProbable0 Participants
XIENCE™Number of Participants With Acute Stent/Scaffold ThrombosisDefinite0 Participants
XIENCE™Number of Participants With Acute Stent/Scaffold ThrombosisProbable0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With Acute/Subacute Stent/Scaffold ThrombosisDefinite2 Participants
Absorb BVS™Number of Participants With Acute/Subacute Stent/Scaffold ThrombosisProbable0 Participants
XIENCE™Number of Participants With Acute/Subacute Stent/Scaffold ThrombosisDefinite0 Participants
XIENCE™Number of Participants With Acute/Subacute Stent/Scaffold ThrombosisProbable0 Participants
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With All Revascularization12 Participants
XIENCE™Number of Participants With All Revascularization12 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With All Revascularization7 Participants
XIENCE™Number of Participants With All Revascularization6 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With All Revascularization2 Participants
XIENCE™Number of Participants With All Revascularization2 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With All Revascularization59 Participants
XIENCE™Number of Participants With All Revascularization34 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With All Revascularization57 Participants
XIENCE™Number of Participants With All Revascularization34 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With All Revascularization49 Participants
XIENCE™Number of Participants With All Revascularization33 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With All Revascularization22 Participants
XIENCE™Number of Participants With All Revascularization18 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With All Revascularization1 Participants
XIENCE™Number of Participants With All Revascularization0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With Cumulative Stent/Scaffold ThrombosisDefinite8 Participants
Absorb BVS™Number of Participants With Cumulative Stent/Scaffold ThrombosisProbable1 Participants
XIENCE™Number of Participants With Cumulative Stent/Scaffold ThrombosisDefinite0 Participants
XIENCE™Number of Participants With Cumulative Stent/Scaffold ThrombosisProbable0 Participants
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With Late Stent/Scaffold ThrombosisDefinite0 Participants
Absorb BVS™Number of Participants With Late Stent/Scaffold ThrombosisProbable1 Participants
XIENCE™Number of Participants With Late Stent/Scaffold ThrombosisDefinite0 Participants
XIENCE™Number of Participants With Late Stent/Scaffold ThrombosisProbable0 Participants
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With Procedural Success322 Participants
XIENCE™Number of Participants With Procedural Success164 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With Subacute Stent/Scaffold ThrombosisDefinite1 Participants
Absorb BVS™Number of Participants With Subacute Stent/Scaffold ThrombosisProbable0 Participants
XIENCE™Number of Participants With Subacute Stent/Scaffold ThrombosisDefinite0 Participants
XIENCE™Number of Participants With Subacute Stent/Scaffold ThrombosisProbable0 Participants
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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

ArmMeasureValue (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
Secondary

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.

ArmMeasureValue (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
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Absorb BVS™Number of Participants With Very Late Stent/Scaffold ThrombosisDefinite6 Participants
Absorb BVS™Number of Participants With Very Late Stent/Scaffold ThrombosisProbable0 Participants
XIENCE™Number of Participants With Very Late Stent/Scaffold ThrombosisDefinite0 Participants
XIENCE™Number of Participants With Very Late Stent/Scaffold ThrombosisProbable0 Participants

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026