Acute Coronary Syndrome, Angina Pectoris, Atherosclerosis, Coronary, Coronary Artery Disease, Ischemic Heart Disease, Myocardial Ischemia
Conditions
Keywords
Drug eluting coronary stents, Sirolimus, Bioabsorbable polymer, DES
Brief summary
The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system.
Detailed description
The BIOTRONIK BIOFLOW-V clinical trial is a prospective, multicenter, randomized, controlled trial combining data on the randomized subjects with data from two historical studies by employing a Bayesian approach. Subjects with CAD that qualify for PCI with stenting will be screened per the protocol inclusion and exclusion criteria to achieve a total of up to 1,400 randomized subjects. Eligible subjects will be randomized in a 2:1 ratio, stratified by study center, to undergo percutaneous coronary revascularization with either the Orsiro Sirolimus Eluting Stent System (treatment group) or the Xience Everolimus Eluting Stent System (control group). Subjects may receive treatment of up to three target lesions, one or two target lesions per target vessel, for a maximum of two target vessels. The target lesion(s) must be de novo or restenotic lesion(s) of ≤ 36 mm in length in native coronary artery(ies), with a reference vessel diameter of 2.25-4.0 mm. Treatment of restenotic lesions is allowed provided that the target lesion was previously treated with PTCA only. All treatment with study stents is to be performed during a single index procedure. Note: Concurrent treatment of non-target lesions during the index procedure is not allowed. Randomized subjects will have clinical follow-up at 1 month, 6 months, 12 months and at 2, 3, 4 and 5 years following the index procedure. To assess the non-inferiority of the Orsiro stent compared to the Xience stent, BIOFLOW-V randomized subjects will be combined with historical subjects from the BIOFLOW-II and BIOFLOW-IV randomized trials employing a Bayesian approach. Only subjects who meet all clinical and angiographic eligibility criteria of the BIOFLOW-V trial will be included in the analysis.
Interventions
DEVICEOrsiro DES
Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
DEVICEXience DES
Sponsors
Biotronik AG
Baim Institute for Clinical Research
Medstar Health Research Institute
Biotronik, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥18 years or the minimum age required for legal adult consent in the country of enrollment. 2. Subject is an acceptable candidate for PCI. 3. Subject is an acceptable candidate for CABG. 4. Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia. 5. Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either, clopidogrel, prasugrel, ticagrelor or ticlopidine. 6. Subject has provided written informed consent. 7. Subject is willing to comply with study follow-up requirements. Each target lesion/vessel must meet all of the following angiographic criteria for the subject to be eligible for the trial: 1. Subject has up to three target lesions in up to two separate target vessels (two target lesions in one vessel and one target lesion in a separate vessel). 2. Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only. 3. Target lesion must be in major coronary artery or branch (target vessel). 4. Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate). If the target lesion is \< 70% stenosed, clinical evidence of ischemia by positive functional study, CT, electrocardiography, FFR, or post infarct angina. 5. TIMI flow \> 1. 6. Target lesion must be ≤ 36 mm in length by operator visual estimate. 7. Target vessel RVD of 2.25-4.0 mm by operator visual estimate. 8. Target lesion must be treatable with a maximum of two overlapping stents.
Exclusion criteria
1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment. 2. Subject is hemodynamically unstable. 3. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study. 4. Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA, sirolimus or everolimus. 5. Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure. 6. Planned treatment of a lesion not meeting angiographic inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation | 12-Months | TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions With Lesion Success | Hospital Discharge (6-24 hours post-index procedure) | Defined as attainment of \< 30% residual stenosis of the target lesion using any percutaneous method. |
| Number of Participants With Procedure Success | Hospital Discharge (6-24 hours post-index procedure) | Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR). |
| Number of Participants With Myocardial Infarction | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | — |
| Number of Participants With Myocardial Infarction or Cardiac Death | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | — |
| Number of Lesions With Device Success | Hospital Discharge (6-24 hours post-index procedure) | Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only. |
| Number of Participants With TLF and Individual TLF Components | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | TLF events are defined as cardiac death, target vessel Q-wave or non-Q-wave MI, or any clinically-driven TLR. The number of participants with any TLF event is provided, as well as number of participants with each of the individual components. |
| Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | TVF events are defined as cardiac death, target vessel Q-wave or non-Q-wave MI, or any clinically-driven TVR. The number of participants with any TVF event is provided, as well as number of participants with each of the individual components. |
| Number of Participants With Stent Thrombosis | 24 hours, 30 days, 1 year, and 5 years post-index procedure | Stent thrombosis according to the Academic Research Consortium criteria. |
| Number of Participants With MACE and Individual MACE Components | Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years | MACE events are defined as all-cause death, Q-wave or non-Q-wave MI, or any clinically-driven TLR. The number of participants with any MACE event is provided, as well as number of participants with each of the individual components. |
Countries
Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, Netherlands, New Zealand, South Korea, Spain, Switzerland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Orsiro Sirolimus Coronary Stent System Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating. | 884 |
| Xience Everolimus Coronary Stent System Intervention with a Xience DES.
Xience DES | 450 |
| Total | 1,334 |
Baseline characteristics
| Characteristic | Xience Everolimus Coronary Stent System | Total | Orsiro Sirolimus Coronary Stent System |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 10.67 | 64.5 years STANDARD_DEVIATION 10.44 | 64.5 years STANDARD_DEVIATION 10.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 48 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 417 Participants | 1229 Participants | 812 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 57 Participants | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 42 Participants | 29 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 37 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 12 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 42 Participants | 27 Participants |
| Race (NIH/OMB) White | 406 Participants | 1198 Participants | 792 Participants |
| Sex: Female, Male Female | 122 Participants | 346 Participants | 224 Participants |
| Sex: Female, Male Male | 328 Participants | 988 Participants | 660 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 56 / 884 | 27 / 450 |
| other Total, other adverse events | 291 / 884 | 165 / 450 |
| serious Total, serious adverse events | 548 / 884 | 293 / 450 |
Outcome results
Primary
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation
TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Time frame: 12-Months
Population: Pre-specified Bayesian analysis: BIOFLOW-V intent-to-treat subjects who experienced the primary endpoint or had at least 330 days of follow-up and BIOFLOW-II (NCT01356888) and BIOFLOW-IV (NCT01939249) subjects who satisfied the BIOFLOW-V inclusion/exclusion criteria and experienced the primary endpoint or had at least 330 days of follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation | 6.32 Percentage of participants | Standard Deviation 0.75 |
| Xience Everolimus Coronary Stent System | Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation | 8.90 Percentage of participants | Standard Deviation 1.22 |
Comparison: Bayesian calculation using a hierarchical model to incorporate data from previous BIOFLOW-II and BIOFLOW-IV trials.
Secondary
Number of Lesions With Device Success
Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only.
Time frame: Hospital Discharge (6-24 hours post-index procedure)
Population: Device Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Lesions With Device Success | 1082 Lesions |
| Xience Everolimus Coronary Stent System | Number of Lesions With Device Success | 566 Lesions |
p-value: 0.415Fisher Exact
Secondary
Number of Lesions With Lesion Success
Defined as attainment of \< 30% residual stenosis of the target lesion using any percutaneous method.
Time frame: Hospital Discharge (6-24 hours post-index procedure)
Population: Lesion Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Lesions With Lesion Success | 1102 Lesions |
| Xience Everolimus Coronary Stent System | Number of Lesions With Lesion Success | 579 Lesions |
Secondary
Number of Participants With MACE and Individual MACE Components
MACE events are defined as all-cause death, Q-wave or non-Q-wave MI, or any clinically-driven TLR. The number of participants with any MACE event is provided, as well as number of participants with each of the individual components.
Time frame: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-24 hours post-index MACE Component: Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-month MACE Component: Clinically-driven TLR | 13 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-24 hours post-index MACE Component: Clinically-driven TLR | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 12-month MACE Total | 59 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 2-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 56 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 12-month MACE Component: Death | 7 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 1-month MACE Total | 39 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 12-month MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 41 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 4-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 66 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 12-month MACE Component: Clinically-driven TLR | 17 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 1-month MACE Component: Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 2-year MACE Total | 85 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 4-year MACE Component: Clinically-driven TLR | 38 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 2-year MACE Component: Death | 16 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 2-year MACE Component: Clinically-driven TLR | 21 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 1-month MACE Component: Protocol defined Q-Wave or non-Q-wave MI | 38 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 3-year MACE Total | 102 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 3-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 60 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 5-year MACE Total | 155 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 3-year MACE Component: Clinically-driven TLR | 27 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 1-month MACE Component: Clinically-driven TLR | 4 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 4-year MACE Total | 133 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 3-year MACE Component: Death | 27 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 4-year MACE Component: Death | 45 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-month MACE Total | 53 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-24 hours post-index MACE Total | 35 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 5-year MACE Component: Death | 56 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-month MACE Component: Death | 6 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 5-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 76 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-24 hours post-index MACE Component: Protocol defined Q-Wave or non-Q-wave MI | 34 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 5-year MACE Clinically-driven TLR | 48 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-month MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 40 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 5-year MACE Clinically-driven TLR | 32 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-24 hours post-index MACE Component: Protocol defined Q-Wave or non-Q-wave MI | 30 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 2-year MACE Component: Death | 9 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 2-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 42 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 3-year MACE Total | 73 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 3-year MACE Component: Death | 17 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 4-year MACE Component: Death | 22 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 5-year MACE Total | 92 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-24 hours post-index MACE Total | 31 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-24 hours post-index MACE Component: Clinically-driven TLR | 2 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 1-month MACE Total | 32 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 1-month MACE Component: Death | 1 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 1-month MACE Component: Protocol defined Q-Wave or non-Q-wave MI | 31 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 1-month MACE Component: Clinically-driven TLR | 3 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-month MACE Total | 42 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-month MACE Component: Death | 4 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-month MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 36 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-month MACE Component: Clinically-driven TLR | 8 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 12-month MACE Total | 44 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 12-month MACE Component: Death | 6 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 12-month MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 37 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 12-month MACE Component: Clinically-driven TLR | 10 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 2-year MACE Total | 56 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 2-year MACE Component: Clinically-driven TLR | 19 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 3-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 49 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 3-year MACE Component: Clinically-driven TLR | 25 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 4-year MACE Total | 81 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 4-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 52 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 4-year MACE Component: Clinically-driven TLR | 28 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 5-year MACE Component: Death | 27 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 5-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI | 58 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With MACE and Individual MACE Components | 6-24 hours post-index MACE Component: Death | 1 Participants |
Secondary
Number of Participants With Myocardial Infarction
Time frame: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 6-24 hours post-index procedure | 34 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 1-month post-index procedure | 38 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 6-month | 40 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 12-month | 41 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 2-year | 56 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 3-year | 60 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 4-year | 66 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 5-year | 76 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 5-year | 58 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 6-24 hours post-index procedure | 30 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 2-year | 42 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 1-month post-index procedure | 31 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 4-year | 52 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 6-month | 36 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 3-year | 49 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction | 12-month | 37 Participants |
Secondary
Number of Participants With Myocardial Infarction or Cardiac Death
Time frame: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 12-month | 42 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 2-year | 61 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 3-year | 68 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | Hospital Discharge (6-24 hours post-index procedure) | 35 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 1-month | 39 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 6-month | 41 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 4-year | 82 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 5-year | 94 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 3-year | 51 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 12-month | 39 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 1-month | 31 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 2-year | 43 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 5-year | 61 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 4-year | 54 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | 6-month | 37 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Myocardial Infarction or Cardiac Death | Hospital Discharge (6-24 hours post-index procedure) | 30 Participants |
Secondary
Number of Participants With Procedure Success
Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR).
Time frame: Hospital Discharge (6-24 hours post-index procedure)
Population: Procedure success was analyzed per subject: for a subject to be considered a procedure success, all of the subject's target lesions had to be considered device success. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Procedure Success | 827 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Procedure Success | 401 Participants |
Secondary
Number of Participants With Stent Thrombosis
Stent thrombosis according to the Academic Research Consortium criteria.
Time frame: 24 hours, 30 days, 1 year, and 5 years post-index procedure
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Definite/Probable ARC Stent Thrombosis Total | 5 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Possible ARC Stent Thrombosis Acute (<=24 hours) | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Definite/Probable ARC Stent Thrombosis Acute (<=24 hours) | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Possible ARC Stent Thrombosis Late (>30 days and <=1 year) | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Definite/Probable ARC Stent Thrombosis Sub-acute (>24 hours and <=30 days) | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Possible ARC Stent Thrombosis Total | 11 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Definite/Probable ARC Stent Thrombosis Late (>30 days and <=1 year) | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Possible ARC Stent Thrombosis Very Late (>1 year) | 11 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Definite/Probable ARC Stent Thrombosis Very Late (>1 year) | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Possible ARC Stent Thrombosis Sub-acute (>24 hours and <=30 days) | 0 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Definite/Probable ARC Stent Thrombosis Very Late (>1 year) | 4 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Possible ARC Stent Thrombosis Acute (<=24 hours) | 0 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Possible ARC Stent Thrombosis Sub-acute (>24 hours and <=30 days) | 0 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Possible ARC Stent Thrombosis Late (>30 days and <=1 year) | 1 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Possible ARC Stent Thrombosis Very Late (>1 year) | 5 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Definite/Probable ARC Stent Thrombosis Total | 7 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Definite/Probable ARC Stent Thrombosis Acute (<=24 hours) | 0 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Definite/Probable ARC Stent Thrombosis Sub-acute (>24 hours and <=30 days) | 1 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Definite/Probable ARC Stent Thrombosis Late (>30 days and <=1 year) | 2 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Stent Thrombosis | Possible ARC Stent Thrombosis Total | 6 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
TVF events are defined as cardiac death, target vessel Q-wave or non-Q-wave MI, or any clinically-driven TVR. The number of participants with any TVF event is provided, as well as number of participants with each of the individual components.
Time frame: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-month TVF Total | 51 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-24 hours post-index TVF Component: Cardiac Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-24 hours post-index TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 34 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-24 hours post-index TVF Component: Clinically-driven TVR | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 1-month TVF Total | 38 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 1-month TVF Component: Cardiac Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 1-month TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 36 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 1-month TVF Component: Clinically-driven TVR | 5 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-24 hours post-index TVF Total | 35 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-month TVF Component: Cardiac Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-month TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 38 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-month TVF Component: Clinically-driven TVR | 18 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 12-month TVF Total | 60 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 12-month TVF Component: Cardiac Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 12-month TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 39 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 12-month TVF Component: Clinically-driven TVR | 27 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 2-year TVF Total | 74 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 2-year TVF Component: Cardiac Death | 5 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 2-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 45 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 2-year TVF Component: Clinically-driven TVR | 37 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 3-year TVF Total | 84 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 3-year TVF Component: Cardiac Death | 9 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 3-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 46 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 3-year TVF Component: Clinically-driven TVR | 45 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 4-year TVF Total | 110 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 4-year TVF Component: Cardiac Death | 17 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 4-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 49 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 4-year TVF Component: Clinically-driven TVR | 63 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 5-year TVF Total | 127 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 5-year TVF Component: Cardiac Death | 21 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 5-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 56 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 5-year TVF Component: Clinically-driven TVR | 78 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 5-year TVF Component: Clinically-driven TVR | 51 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-24 hours post-index TVF Total | 31 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 2-year TVF Total | 56 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-24 hours post-index TVF Component: Cardiac Death | 1 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 4-year TVF Total | 74 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-24 hours post-index TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 29 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 2-year TVF Component: Cardiac Death | 2 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-24 hours post-index TVF Component: Clinically-driven TVR | 2 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 5-year TVF Total | 81 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 1-month TVF Total | 32 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 2-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 39 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 1-month TVF Component: Cardiac Death | 1 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 4-year TVF Component: Cardiac Death | 5 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 1-month TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 30 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 2-year TVF Component: Clinically-driven TVR | 30 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 1-month TVF Component: Clinically-driven TVR | 4 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 5-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 45 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-month TVF Total | 40 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 3-year TVF Total | 68 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-month TVF Component: Cardiac Death | 2 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 4-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 44 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-month TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 34 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 3-year TVF Component: Cardiac Death | 5 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 6-month TVF Component: Clinically-driven TVR | 10 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 5-year TVF Component: Cardiac Death | 8 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 12-month TVF Total | 45 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 3-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 41 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 12-month TVF Component: Cardiac Death | 3 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 4-year TVF Component: Clinically-driven TVR | 46 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 12-month TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 35 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 3-year TVF Component: Clinically-driven TVR | 40 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components | 12-month TVF Component: Clinically-driven TVR | 15 Participants |
Secondary
Number of Participants With TLF and Individual TLF Components
TLF events are defined as cardiac death, target vessel Q-wave or non-Q-wave MI, or any clinically-driven TLR. The number of participants with any TLF event is provided, as well as number of participants with each of the individual components.
Time frame: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-24 hours post-index TLF Component: Clinically-driven TLR | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-month TLF Component: Cardiac Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-month TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 38 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 2-year TLF Total | 64 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 2-year TLF Component: Cardiac Death | 5 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 3-year TLF Component: Cardiac Death | 9 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 3-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 46 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-24 hours post-index TLF Total | 35 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-24 hours post-index TLF Component: Cardiac Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-24 hours post-index TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 34 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 1-month TLF Total | 37 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 1-month TLF Component: Cardiac Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 1-month TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 36 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 1-month TLF Component: Clinically-driven TLR | 4 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-month TLF Total | 47 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-month TLF Component: Clinically-driven TLR | 13 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 12-month TLF Total | 52 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 12-month TLF Component: Cardiac Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 12-month TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 39 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 12-month TLF Component: Clinically-driven TLR | 17 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 2-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 45 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 2-year TLF Component: Clinically-driven TLR | 21 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 3-year TLF Total | 72 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 3-year TLF Component: Clinically-driven TLR | 27 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 4-year TLF Total | 91 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 4-year TLF Component: Cardiac Death | 17 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 4-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 49 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 4-year TLF Component: Clinically-driven TLR | 38 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 5-year TLF Total | 104 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 5-year TLF Component: Cardiac Death | 21 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 5-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 56 Participants |
| Orsiro Sirolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 5-year TLF Component: Clinically-driven TLR | 48 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 12-month TLF Total | 41 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 4-year TLF Total | 60 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-month TLF Component: Cardiac Death | 2 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 12-month TLF Component: Cardiac Death | 3 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 5-year TLF Total | 66 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 2-year TLF Total | 48 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 12-month TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 35 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 3-year TLF Total | 56 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 4-year TLF Component: Cardiac Death | 5 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 3-year TLF Component: Cardiac Death | 5 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 12-month TLF Component: Clinically-driven TLR | 10 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 2-year TLF Component: Cardiac Death | 2 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-24 hours post-index TLF Total | 31 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 5-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 45 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-24 hours post-index TLF Component: Cardiac Death | 1 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 2-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 39 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-24 hours post-index TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 29 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-24 hours post-index TLF Component: Clinically-driven TLR | 2 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 4-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 44 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 1-month TLF Total | 32 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 2-year TLF Component: Clinically-driven TLR | 19 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 1-month TLF Component: Cardiac Death | 1 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 5-year TLF Component: Cardiac Death | 8 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 1-month TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 30 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 3-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 41 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 1-month TLF Component: Clinically-driven TLR | 3 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 4-year TLF Component: Clinically-driven TLR | 28 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-month TLF Total | 39 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-month TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI | 34 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 3-year TLF Component: Clinically-driven TLR | 25 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 6-month TLF Component: Clinically-driven TLR | 8 Participants |
| Xience Everolimus Coronary Stent System | Number of Participants With TLF and Individual TLF Components | 5-year TLF Component: Clinically-driven TLR | 32 Participants |