XIENCE 28 USA Study

Coronary Artery Disease Clinical Trial

Official title:

XIENCE 28 USA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815175
• Other study ID #: ABT-CIP-10402
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: February 4, 2021

Study information

• Verified date: April 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS and XIENCE Sierra EECSS) of coronary drug-eluting stents.

Description:

The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be registered from approximately 50 sites in the United States and Canada. Subject registration is capped at 75 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting AND have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor as early as 28 days and continued with aspirin monotherapy through 12-month follow-up. All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 USA Study will be pooled with the data from the XIENCE 28 Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA Study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1605
• Est. completion date: February 4, 2021
• Est. primary completion date: August 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Subject is considered at high risk for bleeding (HBR), defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the

benefit:

1. = 75 years of age.

2. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy

3. History of major bleeding which required medical attention within 12 months of the index procedure.

4. History of stroke (ischemic or hemorrhagic).

5. Renal insufficiency (creatinine = 2.0 mg/dl) or failure (dialysis dependent).

6. Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count <100,000/mm3, or any known coagulation disorder associated with increased bleeding risk).

7. Anemia with hemoglobin < 11g/dl.

2. Subject must be at least 18 years of age.

3. Subject must provide written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site prior to any trial related procedure.

4. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.

5. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure, except for cases where subject is transferred to the XIENCE 90 study after the 1-month visit assessment Angiographic Inclusion Criteria

1. Up to three target lesions with a maximum of two target lesions per epicardial vessel.

Note:

• The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have >2 lesions requiring treatment within both the LAD and a diagonal branch in total.
• 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.

2. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.

3. Exclusive use of XIENCE family of stent systems during the index procedure.

4. Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final TIMI-3 flow assessed by online quantitative angiography or visual estimation, with no residual dissection NHLBI grade = type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.

Exclusion Criteria:

1. Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).

2. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.

3. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.

4. Subject has a known left ventricular ejection fraction (LVEF) <30%.

5. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.

6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.

7. Subject with a current medical condition with a life expectancy of less than 12 months.

8. Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure. Transferring to the XIENCE 90 study will not be an exclusion criterion.

9. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

10. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

11. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. Angiographic Exclusion Criteria

1. Target lesion is in a left main location.

2. Target lesion is located within an arterial or saphenous vein graft.

3. Target lesion is restenotic from a previous stent implantation.

4. Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).

5. Target lesion is implanted with overlapping stents, whether planned or for bailout.

Related Conditions & MeSH terms

• Anemia
• Bleeding Disorder
• Blood Coagulation Disorders
• Coagulation Disorder
• Coronary Artery Disease
• Coronary Disease
• Disease
• Hematologic Diseases
• Hematological Diseases
• Hemorrhagic Stroke
• Hemostatic Disorders
• Ischemic Stroke
• Myocardial Ischemia
• Renal Insufficiency
• Stroke
• Thrombocytopenia

Intervention

Device:
• XIENCE
Subjects who received XIENCE family stent systems will be included.

Drug:
• DAPT (aspirin and/or P2Y12 receptor inhibitor)
"1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.

Locations

Country	Name	City	State
Austria	Kepler Universitätsklinikum GmbH	Linz	Upr Aus
Belgium	Onze-Lieve-Vrouwziekenhuis Campus Aalst	Aalst	Eflndrs
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg
Belgium	UZ Gent	Gent	Flemish
Belgium	Jesse Ziekenhuis Campus Virga Jesse	Limbourg
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Hopital du Sacre-Coeur de	Montréal	Quebec
Canada	Institute de Cardiologie de Montreal (Montreal Heart Inst.)	Montréal	Quebec
Canada	Saint John Regional Hospital - New Brunswick Heart Centre	Saint John	New Brunswick
Canada	Royal Jubilee Hospital	Victoria	British Columbia
China	Beijing AnZhen Hospital	Beijing	Beijing
China	The Second Hospital of Jilin University	Changchun	N China
Germany	Universitäts-Herzzentrum Freiburg - Bad Krozingen	Bad Krozingen	Bad-Wur
Germany	Segeberger Kliniken GmbH Am Kurpark 1	Bad Segeberg	Schlesw
Germany	Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)	Berlin
Germany	Elisabeth-Krankenhaus Essen GmbH	Essen	N. Rhin
Germany	UKE Hamburg (Universitatsklinik Eppendorf)	Hamburg
Germany	Herzzentrum Leipzig GmbH04289	Leipzig	Saxony
Germany	UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität MainzLangenbeckstrasse	Mainz	Rhinela
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Elizabeth Hospital	Hong Kong
Hong Kong	The University of Hong Kong (Queen Mary Hospital)	Hong Kong
Italy	Az.Osp. Universitaria di Ferrara	Cona	Emi-rom
Italy	Centro Cardiologico Monzino	Milano	Lombard
Italy	AOU Federico II - Università degli Studi di Napoli	Napoli	Campani
Italy	Clinica Mediterranea	Napoli	Campani
Italy	AOU di Parma	Parma	Emi-rom
Italy	Policlinico Universitario A. Gemelli	Roma	Latium
Italy	Azienda Ospedaliero Universitaria Policlinico Umberto I	Rome	Latium
Italy	Istituto Clinico Humanitas	Rozzano	Lombard
Netherlands	Albert Schweitzer Ziekenhuis Albert Schweitzerplaats	Dordrecht	Zuid
Netherlands	Scheperziekenhuis Boermarkeweg	Emmen	Drenthe
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesld
Portugal	Hospital de Santa Cruz	Carnaxide	Lisbon
Portugal	Santa Maria Hospital	Lisboa	Lisbon
Singapore	National Heart Centre	Singapore	Central Singapore
Singapore	Tan Tock Seng Hospital	Singapore	Singapore Central
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona	Catalon
Spain	Hospital del Mar Passeig Maritim de la Barceloneta	Barcelona	Catalon
Spain	Hospital Universitario Doce de Octubre	Madrid
Spain	HCU Virgen de la Victoria Campus Universitario de Teatinos	Málaga	Andalu
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabr
Spain	Hospital Clinico Universitario de Valladolid	Valladolid	Cstleon
Spain	Hospital Alvaro Cunqueiro	Vigo	Pontev
Switzerland	Kantonsspital Aarau	Aarau	Basel
Switzerland	Center Inselspital Bern	Bern
Switzerland	Luzerner Kantonsspital	Luzern
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung	STailwan
Taiwan	Chang Gung Memorial Hospital	Linkou	NTaiwan
Taiwan	National Taiwan University Hospital	Taipei	NTaiwan
Taiwan	Taipei Veterans General Hospital (VGH)	Taipei	Ntaiwan
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Sowest
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Royal Devon & Exeter Hospital	Exeter	Sowest
United Kingdom	Freeman Hospital	High Heaton	Newcastle Upon Tyne
United Kingdom	Craigavon Area Hospital	Portadown	Nirelnd
United Kingdom	Southampton University Hospital	Southampton	Soeast
United States	Anmed Health	Anderson	South Carolina
United States	McLaren Health Care Corporation	Auburn Hills	Michigan
United States	Austin Heart	Austin	Texas
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Beth Isreal Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Novant Health Heart and Vascular Research Institute	Charlotte	North Carolina
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Morton Plant Hospital	Clearwater	Florida
United States	Missouri Heart Center	Columbia	Missouri
United States	Baylor Scott and White Heart and Vascular Hospital	Dallas	Texas
United States	UPMC Hamot	Erie	Pennsylvania
United States	Mary Washington Hospital	Fredericksburg	Virginia
United States	Mission Cardiovascular Research Institute	Fremont	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Cone Health Medical Group Heartcare	Greensboro	North Carolina
United States	Pinnacle Health System	Harrisburg	Pennsylvania
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	Kettering Medical Center	Kettering	Ohio
United States	East Tennessee Heart Consultants	Knoxville	Tennessee
United States	Scripps Memorial Hospital - La Jolla	La Jolla	California
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Centennial Medical Center	Nashville	Tennessee
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Mission Research Institute	New Braunfels	Texas
United States	Lenox Hill Hospital	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Cardiology Associates of Fairfield County, PC	Norwalk	Connecticut
United States	Huntington Memorial Hospital	Pasadena	California
United States	Presbyterian Medical Center (PA)	Philadelphia	Pennsylvania
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	NC Heart & Vascular Research	Raleigh	North Carolina
United States	St. Joseph Medical Center	Reading	Pennsylvania
United States	HeartPlace Methodist Richardson	Richardson	Texas
United States	Redmond Regional Medical Center	Rome	Georgia
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Kaiser Permanente - Santa Clara	Santa Clara	California
United States	Scottsdale Healthcare Shea	Scottsdale	Arizona
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	St. Joseph's Hospital Health Center	Syracuse	New York
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Munson Medical Center	Traverse City	Michigan
United States	East Texas Medical Center	Tyler	Texas
United States	Washington Hospital Center	Washington	District of Columbia
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Via Christi Regional Medical Center - St. Francis Campus	Wichita	Kansas
United States	Wake Forest University Medical Center Clinical Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  China,  Germany,  Hong Kong,  Italy,  Netherlands,  Portugal,  Singapore,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.; MI Definition (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality; AND confirmed with elevated cardiac biomarkers per ARC criteria: Peripheral MI; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL	From 1 to 6 months
Primary	Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.; MI Definition (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality; AND confirmed with elevated cardiac biomarkers per ARC criteria: Peripheral MI; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL	From 6 to 12 months
Primary	Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.; MI Definition (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality; AND confirmed with elevated cardiac biomarkers per ARC criteria: Peripheral MI; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL	From 1 to 12 months
Secondary	Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles	Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions: Type 2: Any overt, actionable sign of hemorrhage; Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding; Type 3b: Overt bleeding plus Hb drop = 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents; Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision; Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of = 5 U whole blood/packed red blood cells within a 48h period;Chest tube output = 2L within 24-h period; Type 5: Fatal bleeding; Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious; Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation	From 1 to 6 months
Secondary	Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles	Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions: Type 2: Any overt, actionable sign of hemorrhage; Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding; Type 3b: Overt bleeding plus Hb drop = 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents; Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision; Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of = 5 U whole blood/packed red blood cells within a 48h period;Chest tube output = 2L within 24-h period; Type 5: Fatal bleeding; Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious; Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation	From 6 to 12 months
Secondary	Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles	Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions: Type 2: Any overt, actionable sign of hemorrhage; Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding; Type 3b: Overt bleeding plus Hb drop = 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents; Type 3c: Intracranial hemorrhage; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision; Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of = 5 U whole blood/packed red blood cells within a 48h period;Chest tube output = 2L within 24-h period; Type 5: Fatal bleeding; Type 5a: Probable fatal bleeding;no autopsy/imaging confirmation but clinically suspicious; Type 5b: Definite fatal bleeding;overt bleeding/autopsy/imaging confirmation	From 1 to 12 months
Secondary	Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)	Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause	From 1 to 6 months
Secondary	Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)	Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause	From 6 to 12 months
Secondary	Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)	Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.; Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause	From 1 to 12 months
Secondary	Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)	All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	From 1 to 6 months
Secondary	Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)	All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	From 6 to 12 months
Secondary	Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death)	All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients with coexisting potentially fatal non-cardiac disease (e.g. cancer,infection) should be classified as cardiac.; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure,fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	From 1 to 12 months
Secondary	Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)	All Myocardial Infarction (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality); AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL; Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL; TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.	From 1 to 6 months
Secondary	Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)	All Myocardial Infarction (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality); AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL; Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL; TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.	From 6 to 12 months
Secondary	Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC)	All Myocardial Infarction (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality); AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL; Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL; TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.	From 1 to 12 months
Secondary	Number of Participants With Composite of Cardiac Death or MI (Modified ARC)	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.; MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality; AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL; Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL	From 1 to 6 months
Secondary	Number of Participants With Composite of Cardiac Death or MI (Modified ARC)	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.; MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality; AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL; Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL	From 6 to 12 months
Secondary	Number of Participants With Composite of Cardiac Death or MI (Modified ARC)	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.; MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality; AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URLwith baseline value < URL; Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL	From 1 to 12 months
Secondary	Number of Participants With Composite of All Death or All MI (Modified ARC)	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.; MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality); AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL	From 1 to 6 months
Secondary	Number of Participants With Composite of All Death or All MI (Modified ARC)	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.; MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality); AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL	From 6 to 12 months
Secondary	Number of Participants With Composite of All Death or All MI (Modified ARC)	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g.cancer, infection) should be classified as cardiac.; MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality); AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI; Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL	From 1 to 12 months
Secondary	Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)	An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.; Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.; Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.; Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.; Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)	From 1 to 6 months
Secondary	Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)	An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.; Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.; Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.; Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.; Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)	From 6 to 12 months
Secondary	Number of Participants With All Stroke (Ischemic Stroke and Hemorrhagic Stroke)	An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.; Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.; Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.; Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.; Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)	From 1 to 12 months
Secondary	Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)	Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.; Clinically Indicated [CI] Revascularization: A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis = 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test; A TLR/TVR with a diameter stenosis =70% in the absence of the above mentioned ischemic signs or symptoms.	From 1 to 6 months
Secondary	Number of Participants With CI-TLR	Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.; Clinically Indicated [CI] Revascularization: A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis = 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test; A TLR/TVR with a diameter stenosis =70% in the absence of the above mentioned ischemic signs or symptoms.	From 6 to 12 months
Secondary	Number of Participants With CI-TLR	Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.; Clinically Indicated [CI] Revascularization: A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis = 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test; A TLR/TVR with a diameter stenosis =70% in the absence of the above mentioned ischemic signs or symptoms.	From 1 to 12 months
Secondary	Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)	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.; A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis = 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis =70% in the absence of the above mentioned ischemic signs or symptoms.	From 1 to 6 months
Secondary	Number of Participants With CI-TVR	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.; A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis = 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis =70% in the absence of the above mentioned ischemic signs or symptoms.	From 6 to 12 months
Secondary	Number of Participants With CI-TVR	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.; A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis = 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g.,Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis =70% in the absence of the above mentioned ischemic signs or symptoms.	From 1 to 12 months
Secondary	Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)	TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.	From 1 to 6 months
Secondary	Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)	TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.	From 6 to 12 months
Secondary	Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)	TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.	From 1 to 12 months
Secondary	Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)	TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.	From 1 to 6 months
Secondary	Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)	TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.	From 6 to 12 months
Secondary	Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)	TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.	From 1 to 12 months
Secondary	Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5	Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows: Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding; Type 3b: Overt bleeding plus Hb drop = 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents; Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision; Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of = 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output = 2L within a 24-h period; Type 5: Fatal bleeding; Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious; Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation	From 1 to 6 months
Secondary	Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5	Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows: Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding; Type 3b: Overt bleeding plus Hb drop = 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents; Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision; Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of = 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output = 2L within a 24-h period; Type 5: Fatal bleeding; Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious; Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation	From 6 to 12 months
Secondary	Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5	Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows: Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding; Type 3b: Overt bleeding plus Hb drop = 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents; Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision; Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of = 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output = 2L within a 24-h period; Type 5: Fatal bleeding; Type 5a: Probable fatal bleeding; no autopsy/imaging confirmation but clinically suspicious; Type 5b: Definite fatal bleeding;overt bleeding/autopsy or imaging confirmation	From 1 to 12 months