Absorb IV Randomized Controlled Trial

Not Applicable

Completed

Conditions: Coronary Artery Stenosis
Coronary Stenosis
Coronary Artery Disease
Coronary Disease

Interventions: Device: Absorb BVS
Device: XIENCE

Registration Number: NCT02173379

Lead Sponsor: Abbott Medical Devices

Brief Summary: ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.

Detailed Description: ABSORB IV:

A. Primary Objective:

* To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.

* To evaluate long-term clinical outcomes of Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three denovo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.

B. Secondary Objectives:

* To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.

* To evaluate the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE.

The enrollment of the 2610 subjects in ABSORB IV will start after enrollment completion of the 2000 primary analysis subjects in ABSORB III. All registered subjects will have clinical follow-up at 30, 90, 180, 270 days and 1, 2, 3, 4 and 5 years.

Note: All registered subjects in ABSORB IV will be followed up to 5 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

In addition, all 2610 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, 1 year, 3 years and 5 years.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2604

Inclusion Criteria

Subject must be at least 18 years of age.
Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:
1. Unstable angina or NSTEMI within 2 weeks of the index procedure.
2. STEMI > 72 hours ≤ 2 weeks prior to the index procedure.
Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.
Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR).

(Note: subject with silent ischemia must have a prior history of typical angina, angina-equivalent symptoms, or atypical angina within the past year to be included in the trial.)
Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for at least 1 year following the index procedure.
Subject agrees to not participate in any other investigational or invasive clinical study for a period of 5 years following the index procedure.

Angiographic Inclusion Criteria:

Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion treatment can occur only in a non-target vessel.

If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion for lesion (and stent) length determination and must be treated with a single study device.

Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥50% and < 100%, with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1, and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve ≤0.80 AND/OR a positive stress test), or presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of index procedure, or STEMI >72 hours but ≤ 2 weeks prior to the index procedure).
Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
Target lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

Note: To exclude enrollment of excessively small vessels, if the operator believes that based on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). This measurement may be performed before or after pre-dilatation, but before randomization. If the distal RVD measures <2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such a lesion may be treated as a non-target lesion.

General

Exclusion Criteria

Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 receptor inhibitor is planned within 12 months after the procedure.
Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
Subject has known allergic reaction, hypersensitivity or contraindication to any of the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) within 72 hours of the index procedure.
Subject has a cardiac arrhythmia identified at the time of screening for which at least one of the following criteria is met:
1. Subject requires coumadin or any other agent for chronic oral anticoagulation.
2. Subject is likely to become hemodynamically unstable due to their arrhythmia.
3. Subject has poor survival prognosis due to their arrhythmia.
Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, multiple-gated acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left ventriculography during the index procedure but prior to randomization in order to confirm the subject's eligibility.
Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated.
Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular interventions < 30 days after the index procedure.
Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
At the time of screening, the subject has a malignancy that is not in remission.
Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for any reason).
Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastrointestinal or significant urinary bleed within the past six months.
Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.).
Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
Subject has a life expectancy <5 years for any non-cardiac or cardiac cause.
Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

Unsuccessful pre-dilatation, defined as the presence of one or more of the following (note: successful pre-dilatation of at least one target lesion is required prior to randomization):
1. Residual %diameter stenosis (DS) after pre-dilatation is ≥ 40% (per visual estimation). Note: achieving a %DS ≤ 20% prior to randomization is strongly recommended.
2. TIMI flow grade <3 (per visual estimation).
3. Any angiographic complication (e.g. distal embolization, side branch closure).
4. Any dissection NHLBI grade D-F.
5. Any chest pain lasting > 5 minutes.
6. Any ST-segment depression or elevation lasting > 5 minutes.
Lesion is located in left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft to the LAD and/or LCX arteries is present), and there is no intention to treat the protected left main lesion).
Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
Lesion located within 3 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX).
Lesion involving a bifurcation with a:
1. side branch ≥ 2 mm in diameter, or
2. side branch with either an ostial or non-ostial lesion with diameter stenosis >50%, or
3. side branch requiring dilatation
Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:
1. Extreme angulation (≥ 90°) proximal to or within the target lesion.
2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
3. Moderate or heavy calcification proximal to or within the target lesion. If intravascular ultrasound (IVUS) used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
Lesion or vessel involves a myocardial bridge.
Vessel has been previously treated with a stent and the target lesion is within 5 mm proximal or distal to a previously stented lesion.
Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absorb BVS	Absorb BVS	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
XIENCE	XIENCE	Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) and XIENCE ProX (outside of the US only)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Target Lesion Failure (TLF)	30 days	Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Secondary Outcome Measures

Name	Time	Method
Number of Death (Cardiac, Vascular, Non-cardiovascular)	5 years	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. For the All-Cause Mortality data, the denominator excludes participants who are lost-to-follow-up or withdrawn (by subject or physician) through a given timepoint without any DMR event (all death, MI and revascularization, respectively). If these participants were included in the denominator in each arm, that would equate to assuming that these participants are alive, potentially underestimating the death rate by inflating the denominator.
Number of Participants With Myocardial Infarction (MI)	5 years	* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)	30 days	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)	In-hospital (≤ 7 days post index procedure)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	5 years	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
TLF at 1-year, Non-inferiority Against the Control	1 year	One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.
Angina at 1-year, Non-inferiority Against the Control	1 year	* Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC). * This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	5 years	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants Experienced All Death/All MI	5 years	All deaths includes * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)	In-hospital (≤ 7days)	Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)	In-hospital (≤ 7days)	Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
Number of Participants With Target Vessel Revascularization (TVR)	5 years	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR	5 years	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. * TVR includes both Ischemic driven TVR and Non-ischemic driven TVR. * TVR includes all TVR, excluding TLR
Number of Participants Experienced Cardiac Death/All MI	5 years	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	5 years	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	In-hospital (≤ 7 days post index procedure)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)	5 years	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 Target Lesion Revascularization (TLR)	5 years	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants With Ischemia Driven TLR (ID-TLR)	5 years	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With All Coronary Revascularization	5 years	Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition)	0 to 730 Days	Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained
Number of Participants withTarget Lesion Revascularization (TLR)	90 days	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)	5 years	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 Rehospitalization	5 years	* CAD related * Cardiovascular, non-CAD related * Non-cardiovascular related
Number of Participants With Target Lesion Failure (TLF)	1 year	The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)
Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)	0 - 24 hours post stent implantation	Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition)	>24 hours - 30 days post stent implantation	Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)	30 days - 1 year post stent implantation	Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).
Number of Participants With Repeat Coronary Arteriography	5 years

Trial Locations

Locations (120): Stony Brook University Medical Center
🇺🇸
Stony Brook, New York, United States
Aultman Hospital
🇺🇸
Canton, Ohio, United States
Penn Presbyterian Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Houston Methodist Hospital
🇺🇸
Houston, Texas, United States
The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
Royal Perth Hospital
🇦🇺
Perth, Western Australia, Australia
Integris Baptist Medical Center, Inc.
🇺🇸
Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
St. Patrick Hospital
🇺🇸
Missoula, Montana, United States
Kliniken Oberallgau gGmbH
🇩🇪
Immenstadt, Bavaria, Germany
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
Klinikum Kempten, Klinikverbund Kempten-Oberallgaeu gGmbH
🇩🇪
Kempten-Allgau, Bavaria, Germany
Johannes Gutenberg-Universitaet
🇩🇪
Mainz, Rhineland-Palatinate, Germany
Rochester General Hospital
🇺🇸
Rochester, New York, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Klinikum Oldenburg
🇩🇪
Oldenburg, Lower Saxony, Germany
University Giessen
🇩🇪
Giessen, Hesse, Germany
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
CHI Health Bergan Mercy
🇺🇸
Omaha, Nebraska, United States
Carolinas Medical Center-Northeast
🇺🇸
Charlotte, North Carolina, United States
Mercy Gilbert Medical Center
🇺🇸
Gilbert, Arizona, United States
Univ Of California Davis Med Ctr
🇺🇸
Sacramento, California, United States
John Muir Health Concord
🇺🇸
Concord, California, United States
Sharp Memorial Hospital
🇺🇸
San Diego, California, United States
Washington Hospital
🇺🇸
Fremont, California, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Stanford Hospital and Clinics
🇺🇸
Stanford, California, United States
Medical Center of the Rockies
🇺🇸
Loveland, Colorado, United States
Baptist Medical Center Jacksonville
🇺🇸
Jacksonville, Florida, United States
Morton Plant Hospital
🇺🇸
Clearwater, Florida, United States
Tallahassee Memorial Hospital
🇺🇸
Tallahassee, Florida, United States
UF Health Jacksonville
🇺🇸
Jacksonville, Florida, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Elkhart General Hospital
🇺🇸
Elkhart, Indiana, United States
St. John's Hospital
🇺🇸
Springfield, Illinois, United States
Eastern Maine Medical Center
🇺🇸
Bangor, Maine, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
MedStar Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
Boston Medical Center
🇺🇸
Boston, Massachusetts, United States
St John Hospital & Medical Center
🇺🇸
Detroit, Michigan, United States
North Mississippi Medical Center
🇺🇸
Tupelo, Mississippi, United States
Mercy Hospital Springfield
🇺🇸
Springfield, Missouri, United States
Barnes Jewish Hospital
🇺🇸
Saint Louis, Missouri, United States
Nebraska Heart Institute Heart Hosp.
🇺🇸
Lincoln, Nebraska, United States
Cooper University Hospital
🇺🇸
Camden, New Jersey, United States
Our Lady of Lourdes Medical Center
🇺🇸
Camden, New Jersey, United States
Englewood Hospital and Medical Center
🇺🇸
Englewood, New Jersey, United States
NewYork-Presbyterian/Queens
🇺🇸
Flushing, New York, United States
NYP Weill Cornell Medical Center
🇺🇸
New York, New York, United States
Novant Health Heart & Vascular Institute/Presbyterian Hospital
🇺🇸
Charlotte, North Carolina, United States
Carolinas Medical Center-Pineville
🇺🇸
Charlotte, North Carolina, United States
Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
St. Joseph's Hospital Health Center
🇺🇸
Syracuse, New York, United States
Wake Forest Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Mercy St. Vincent Medical Center
🇺🇸
Toledo, Ohio, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Providence St. Vincent Medical Center
🇺🇸
Portland, Oregon, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
The Miriam Hospital
🇺🇸
Providence, Rhode Island, United States
St. Joseph Medical Center
🇺🇸
Reading, Pennsylvania, United States
Anmed Health Medical Center
🇺🇸
Anderson, South Carolina, United States
Wellmont Holston Valley Medical Center
🇺🇸
Kingsport, Tennessee, United States
Providence Hospital
🇺🇸
Columbia, South Carolina, United States
Baylor Heart and Vascular Hospital
🇺🇸
Dallas, Texas, United States
Carilion Roanoke Memorial Hospital
🇺🇸
Roanoke, Virginia, United States
Liverpool Hospital
🇦🇺
Liverpool, New South Wales, Australia
St. Michael's Hospital
🇨🇦
Toronto, Ontario, Canada
St Vincent's Hospital Melbourne
🇦🇺
Fitzroy, Victoria, Australia
Royal Brisbane and Women's Hospital
🇦🇺
Herston, Queensland, Australia
The Prince Charles Hospital
🇦🇺
Brisbane, Queensland, Australia
Medstar Health Research Institute/ Medstar Washington Hospital Center
🇺🇸
Northwest, Washington, United States
Montreal Heart Institute
🇨🇦
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
🇨🇦
Montreal, Quebec, Canada
CHUM-Hotel Dieu
🇨🇦
Montréal, Quebec, Canada
Universitätsklinikum Ulm
🇩🇪
Ulm, Baden-Württemberg, Germany
Universitatsklinikum Freiburg
🇩🇪
Freiburg, Baden-Württemberg, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
🇩🇪
Bernau, Berlin, Germany
Universitatsklinikum Bonn
🇩🇪
Bonn, North Rhine-Westphalia, Germany
Elisabeth-Krankenhaus
🇩🇪
Essen, North Rhine-Westphalia, Germany
Segeberger Kliniken GmbH - Herzzentrum
🇩🇪
Bad Segeberg, Schleswig-Holstein, Germany
National Heart Centre, Singapore, Pte, Ltd.
🇸🇬
Singapore, Singapore
University Of Kentucky Hospital
🇺🇸
Lexington, Kentucky, United States
Emory University Hospital Midtown
🇺🇸
Atlanta, Georgia, United States
Yale-New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
Seton Medical Center
🇺🇸
Austin, Texas, United States
East Texas Medical Center
🇺🇸
Tyler, Texas, United States
Doylestown Hospital
🇺🇸
Doylestown, Pennsylvania, United States
Forbes Hospital
🇺🇸
Monroeville, Pennsylvania, United States
St. Joseph Mercy Hospital
🇺🇸
Ann Arbor, Michigan, United States
Harper University Hospital
🇺🇸
Detroit, Michigan, United States
Northern Michigan Hospital
🇺🇸
Petoskey, Michigan, United States
Genesis Hospital
🇺🇸
Zanesville, Ohio, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Scripps Memorial Hospital La Jolla
🇺🇸
La Jolla, California, United States
Little Company Of Mary Hospital
🇺🇸
Torrance, California, United States
Scottsdale Healthcare
🇺🇸
Scottsdale, Arizona, United States
Franciscan St Francis Health
🇺🇸
Indianapolis, Indiana, United States
Dartmouth Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Northwest Texas Healthcare System
🇺🇸
Amarillo, Texas, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Upmc Presbyterian
🇺🇸
Pittsburgh, Pennsylvania, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
Chandler Regional Medical Center
🇺🇸
Chandler, Arizona, United States
Tampa General Hospital
🇺🇸
Tampa, Florida, United States
Holy Cross Hospital
🇺🇸
Fort Lauderdale, Florida, United States
Jewish Hospital
🇺🇸
Louisville, Kentucky, United States
Baptist Health Lexington
🇺🇸
Lexington, Kentucky, United States
Boone Hospital Center/ Missouri Cardiovascular Specialists, LLP
🇺🇸
Columbia, Missouri, United States
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
WakeMed
🇺🇸
Raleigh, North Carolina, United States
Rex Hospital, Inc.
🇺🇸
Raleigh, North Carolina, United States
Holy Spirit Hospital
🇺🇸
Camp Hill, Pennsylvania, United States
Pinnacle Health Hospitals
🇺🇸
Harrisburg, Pennsylvania, United States
Winchester Medical Center
🇺🇸
Winchester, Virginia, United States
Providence Reg Med Ctr Everett
🇺🇸
Everett, Washington, United States
Fiona Stanley Hospital
🇦🇺
Murdoch, Western Australia, Australia
Montefiore Medical Center
🇺🇸
Bronx, New York, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States