The Dual Antiplatelet Therapy Study (DAPT Study)

Coronary Artery Disease Clinical Trial

Official title:

A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977938
• Other study ID #: HCRIG080186
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2009
• Last updated: September 18, 2015
• Start date: October 2009
• Est. completion date: June 2014

Study information

• Verified date: September 2015
• Source: Harvard Clinical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.

Description:

Subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention (PCI) with stent placement and no contraindications to prolonged dual antiplatelet therapy are eligible to be enrolled in the study.

All enrolled subjects will undergo PCI with stent placement. All enrolled subjects will be treated with either an FDA-approved drug eluting stent(s) (DES) or an FDA-approved bare metal stent(s) (BMS) (per their respective Instructions for Use) and assigned to 12 months of open label FDA-approved thienopyridine treatment in addition to aspirin. Operators will select the thienopyridine according to the package insert. Thienopyridine treatment dose will be according to the standard of practice and prescribing information for the selected medication. Aspirin treatment will be 75-325 mg for the first 6 months after the procedure and 75-162 mg subsequently, to be continued indefinitely. All DES or BMS subjects who are treated with 12 months of dual antiplatelet therapy post index procedure and who are event free per protocol will be eligible for randomization to either placebo (12 m DAPT Study arm) or an additional 18 months of thienopyridine treatment (30 m DAPT Study arm). Both arms will continue aspirin therapy.

Up to four (4) separate post-market approval studies will be allowed to incorporate the randomized design of the DAPT Study for a subset of subjects who may then be contributed for the DAPT Study analyses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25682
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Enrollment):

1. Subject is > 18 years of age.

2. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).

3. Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.

4. The subject has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form". The informed consent will be valid for the duration of the trial or until the subject withdraws.

Inclusion Criterion (Randomization at 12 months):

1. Subject, at 12 months, is free from death, MI, stroke, repeat coronary revascularization, major bleeding, and stent thrombosis and has been compliant with dual antiplatelet therapy following stent implantation.

Exclusion Criteria (Enrollment):

1. Index procedure stent placement with stent diameter <2.25 mm or >4.0 mm.

2. Pregnant women.

3. Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment.

4. Current medical condition with a life expectancy of less than 3 years.

5. Concurrent enrollment in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a DES or BMS other than those included as DAPT Study devices. The subject may only be enrolled in the DAPT Study once.

6. Subjects on warfarin or similar anticoagulant therapy.

7. Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted.

8. Subjects unable to give informed consent.

9. Subject treated with both DES and BMS during the index procedure.

Exclusion Criteria (Randomization at 12 months):

1. Pregnant women.

2. Subject switched thienopyridine type or dose within 6 months prior to randomization.

3. Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.

4. Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.

5. Current medical condition with a life expectancy of less than 3 years.

6. Subjects on warfarin or similar anticoagulant therapy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Placebo & Aspirin

• Clopidogrel & Aspirin, Prasugrel & Aspirin

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Monash Heart	Clayton
Australia	St. Vincents Hospital Sydney	Darlinghurst	New South Wales
Australia	St Vincents Hospital Melbourne	Fitzroy
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	The Mount Hospital	Nedlands	Western Australia
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	The Alfred Hospital	Prahran	Victoria
Australia	Prince of Wales Eastern Heart	Randwick	New South Wales
Czech Republic	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czech Republic	Krajska karlovarska nemocnice a.s.	Karlovy Vary
Czech Republic	Centrum pro choroby srdce a cev	Kromeriz
Czech Republic	Mestska nemocnice Ostrava	Ostrava
Czech Republic	Krajska nemocnice T. Bati a.s.	Zlin
France	Centre Hospitalier Saint Louis	La Rochelle
France	Hospital Saint Philibert	Lomme
France	Nouvelles Cliniques Nantaises	Nantes
France	Clinique les Franciscaines	Nimes
France	Hopital Bichat	Paris
France	Groupe Hospitalier Sud	Pessac
France	CH Chatiliez Tourcoing	Tourcoing
Germany	Helios Klinikum Emil von Behring	Berlin	BE
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Vivantes-Humboldt Klinikum	Berlin
Germany	Vivantes-Klinikum Neukoelin	Berlin
Germany	Vivantes-Klinikum Neukoelln	Berlin
Germany	Elbe-Kliniken Stade-Buxtehude GmbH	Buxtehude
Germany	Universitaetsklinikum Dresden	Dresden
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Universitaetsklinikum Schleswig-Holstein - PS	Luebeck	SH
Germany	Elbe-Kliniken Stade-Buxtehude GmbH	Stade
Hungary	Gottsegen Gyorgy Orszagos Kardiologiai Intezet	Budapest
Hungary	Josa Andras Oktato Korhaz Nonprofit Kft	Nyiregyhaza
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont	Szeged
Hungary	Zala Megyei Korhaz	Zalaegerszeg
New Zealand	Ascot Hospital	Auckland
New Zealand	Middlemore Hospital	Auckland
New Zealand	North Shore Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Mercy Angiography	Epsom	Auckland
New Zealand	Waikato Hospital	Hamilton
New Zealand	Nelson Hospital	Nelson
New Zealand	Wakefield Hospital	Wellington
New Zealand	Wellington Hospital	Wellington
Poland	Uniwersyteck Szpital Klin. w Bialymstoku	Bialystok
Poland	Wielospecj. Szpital Miejski im.dr.E.Warminskiego-SPZOZ	Bydgoszcz
Poland	NZOZ Centrum Medyczne Beluga-Med	Krakow
Poland	Szpital Uniwersytecki w Krakowie	Krakow
Poland	SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie	Szczecin
Poland	Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S	Ustron
Poland	Instytut Kardiologii im. Kardynala St. Wyszynskiego	Warszawa
Romania	Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei	Bucuresti
Romania	Inst. Urgenta Boli Cardiovasculare Prof. Dr. C.C. Iliescu	Bucuresti
Romania	Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr.	Bucuresti
Romania	Spitalul Clinic de Urgenta Bucuresti	Bucuresti
Romania	Spitalul Clinic Universitar de Urgenta Bucuresti	Bucuresti
Romania	Institutul Inimii Niculae Stancioiu Cluj-Napoca	Cluj-Napoca
Romania	Institutul de Boli Cardiovasculare si Transplant Targu Mures	Targu Mures
United Kingdom	Barnet Hospital	Barnet	Herts
United Kingdom	Basildon University Hospital	Basildon	Essex
United Kingdom	Royal Bournemouth General Hospital	Bournemouth	Dorset
United Kingdom	Papworth Hospital	Cambridge	Cambs
United Kingdom	St Peter's Hospital	Chertsey
United Kingdom	University Hospital of Coventry and Warwickshire	Coventry
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Golden Jubilee National Hospital	Glasgow	Strath
United Kingdom	Wycombe General Hospital	High Wycombe	Bucks
United Kingdom	University Hospital of Leicester Glenfield Hospital	Leicester
United Kingdom	The London Chest Hospital	London
United Kingdom	James Cook Hospital	Middlesborough	N York
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Torbay hospital	Torquay	Devon
United Kingdom	Weston General Hospital	Weston Super Mare	Somerset
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Presbyterian Heart Group	Albuquerque	New Mexico
United States	McFarland Clinic PC	Ames	Iowa
United States	AnMed Health	Anderson	South Carolina
United States	Asheville Cardiology Associates	Asheville	North Carolina
United States	Kings Daughters Medical Center	Ashland	Kentucky
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Piedmont Hospital Research Institute	Atlanta	Georgia
United States	Palm Beach Heart Research Institute	Atlantis	Florida
United States	Medical Center of Aurora	Aurora	Colorado
United States	Austin Heart	Austin	Texas
United States	Capital Cardiovascular Research Institute	Austin	Texas
United States	Texas Cardiovascular	Austin	Texas
United States	Sinai Hospital at Baltimore	Baltimore	Maryland
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Northeast Cardiology Associates	Bangor	Maine
United States	Advocate Good Shephard Hospital	Barrington	Illinois
United States	Bay Regional Medical Center	Bay City	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Bay Area Cardiology Associates/ Brandon Regional Hospital	Brandon	Florida
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Connecticut Clinical Research, LLC	Bridgeport	Connecticut
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	St. Luke's Hospital - Cedar Rapids	Cedar Rapids	Iowa
United States	Chambersburg Hospital	Chambersburg	Pennsylvania
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Chattanooga Heart - East Third Street	Chattanooga	Tennessee
United States	Chattanooga Heart Institute	Chattanooga	Tennessee
United States	Jesse Brown VA Medical Center	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Riverside Methodist	Columbus	Ohio
United States	CRSTI Research	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Veteran's Affairs Medical Center- Dallas	Dallas	Texas
United States	Geisinger Clinic	Danville	Pennsylvania
United States	Harper University Hospital	Detroit	Michigan
United States	Henry Ford Hospital Heart & Vascular Institute	Detroit	Michigan
United States	Good Samaritan Hospital- IL	Downers Grove	Illinois
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Midwest Cardiovascular Research and Education Foundation	Elkhart	Indiana
United States	Elmhurst Memorial Hospital	Elmhurst	Illinois
United States	Elyria Memorial Hospital	Elyria	Ohio
United States	Thomas Hospital	Fairhope	Alabama
United States	MeritCare Medical Center	Fargo	North Dakota
United States	California Cardiovascular Consultants/ Washington Hospital	Fremont	California
United States	Carolina Heart Specialists	Gastonia	North Carolina
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Altru Health System	Grand Forks	North Dakota
United States	Cardiovascular Associates of the Delaware Valley, PA	Haddon Heights	New Jersey
United States	Hamilton Cardiology Associates	Hamilton	New Jersey
United States	Pinnacle Health Hospital	Harrisburg	Pennsylvania
United States	Rockingham Memorial Hospital	Harrisonburg	Virginia
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Valley Hospital	Hawthorne	New Jersey
United States	Carolina Cardiology Associates	High Point	North Carolina
United States	Methodist DeBakey Heart & Vascular Center	Houston	Texas
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	St. Vincent Heart Center of Indiana, LLC	Indianapolis	Indiana
United States	Jacksonville Heart Center	Jacksonville	Florida
United States	Conemaugh Memorial Medical Center	Johnstown	Pennsylvania
United States	Heartland Education and Research Foundation	Joliet	Illinois
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Kansas City Heart Foundation	Kansas City	Missouri
United States	St. Luke's Hospital Mid America Heart Institute	Kansas City	Missouri
United States	The Foundation for Cardiovascular Medicine	La Jolla	California
United States	Watson Clinic Center for Research	Lakeland	Florida
United States	Diagnostic Cardiology Associates	Lauderdale Lakes	Florida
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	University of Arkansas (Central VA) for Medical Science	Little Rock	Arkansas
United States	SJH Cardiology Associates	Liverpool	New York
United States	Lynchburg General Hospital	Lynchburg	Virginia
United States	Medical Center Central Georgia	Macon	Georgia
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Frederick C Smith Clinic dba Smith Clinic	Marion	Ohio
United States	Loyola University Medical Center	Maywood	Illinois
United States	North Dallas Research Associate	McKinney	Texas
United States	North Dallas Research Associates	McKinney	Texas
United States	Melbourne Internal Medicine Assoc	Melbourne	Florida
United States	Baptist Hospital of Miami	Miami	Florida
United States	Midwest Regional Medical Center	Midwest City	Oklahoma
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Heart Care Research Foundation	Mokena	Illinois
United States	Intermountain Medical Center	Murray	Utah
United States	Edward Heart Hospital	Naperville	Illinois
United States	Centennial Heart Medical Center	Nashville	Tennessee
United States	UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Tulane University Medical School	New Orleans	Louisiana
United States	St. Michaels Hospital	Newark	New Jersey
United States	Sentara, Norfolk General Hospital	Norfolk	Virginia
United States	North Kansas City Hospital	North Kansas City	Missouri
United States	Munroe Regional Medical Center	Ocala	Florida
United States	Ocala Regional Medical Center	Ocala	Florida
United States	Oklahoma Foundation for CV Research	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Providence St. Peter Hospital	Olympia	Washington
United States	Alegent Health / Bergan Mercy Hospital	Omaha	Nebraska
United States	Creighton University	Omaha	Nebraska
United States	Florida Hospital	Orlando	Florida
United States	Baptist Hospital	Pensacola	Florida
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Heart & Vascular Center of Arizona	Phoenix	Arizona
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	The Heart Hospital / Baylor Plano	Plano	Texas
United States	St. Joseph Mercy-PTCMI	Pontiac	Michigan
United States	Maine Medical Center	Portland	Maine
United States	Oregon Health & Sciences University Hospital	Portland	Oregon
United States	St. Vincent Hospital/ Providence Heart Hospital	Portland	Oregon
United States	Hudson Valley Heart Center	Poughkeepsie	New York
United States	Shah Associates, LLC	Prince Frederick	Maryland
United States	Miriam Hospital	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Wake Heart Association	Raleigh	North Carolina
United States	Black Hills Research- Rapid City Regional	Rapid City	South Dakota
United States	Carilion Clinic	Roanoke	Virginia
United States	Mayo Clinic - Saint Marys Hospital	Rochester	Minnesota
United States	Redmond Regional Hospital	Rome	Georgia
United States	Scott and White Healthcare - Round Rock	Round Rock	Texas
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	Covenant Medical Center	Saginaw	Michigan
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	TexSan Heart Hospital	San Antonio	Texas
United States	UC San Diego Medical Center	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	Donald Guthrie Foundation for Education and Research	Sayre	Pennsylvania
United States	Scottsdale Health Care	Scottsdale	Arizona
United States	University of Washington	Seattle	Washington
United States	North Central Heart Institute	Sioux Falls	South Dakota
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Inland Cardiology Associates	Spokane	Washington
United States	Sacred Heart Medical Center	Spokane	Washington
United States	St. John's Medical Institute	Springfield	Missouri
United States	Central Minnesota Heart Center at St. Cloud Hospital	St. Cloud	Minnesota
United States	Great Lakes Heart & Vascular Institute, PC	St. Joseph	Michigan
United States	St. John's Mercy Medical Center	St. Louis	Missouri
United States	St. Louis University Hospital	St. Louis	Missouri
United States	Washington University Hospital	St. Louis	Missouri
United States	St. Vincent's Medical Center	Stamford	Connecticut
United States	St. Joseph's Medical Center- CA	Stockton	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Pepin Heart Hospital	Tampa	Florida
United States	Northwest Ohio Cardiology	Toledo	Ohio
United States	Harbor - UCLA Medical Center	Torrance	California
United States	Torrance Memorial Medical Center / Vasek Polak Research Program	Torrance	California
United States	Munson Medical Center	Traverse City	Michigan
United States	Beaumont Hospital Troy	Troy	Michigan
United States	Cardiology Associates Research LLC	Tupelo	Mississippi
United States	Mother Frances Hospital	Tyler	Texas
United States	St. Elizabeth's Medical Center- NY	Utica	New York
United States	Westchester Medical Center	Valhalla	New York
United States	Northwest Indiana Cardiovascular Physicians, P.C.	Valparaiso	Indiana
United States	Cardiovascular Associates, Ltd.	Virginia Beach	Virginia
United States	Providence Healthcare Network	Waco	Texas
United States	Washington Hospital Center	Washington	District of Columbia
United States	CaRE Foundation, Inc.	Wausau	Wisconsin
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Winchester Medical Center	Winchester	Virginia
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina
United States	Winter Haven Hospital	Winter Haven	Florida
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	Berks Cardiologists	Wyomissing	Pennsylvania
United States	York Hospital (PA)	York	Pennsylvania

Sponsors (9)

Lead Sponsor	Collaborator
Harvard Clinical Research Institute	Abbott, Boston Scientific Corporation, Bristol-Myers Squibb, Cordis Corporation, Daiichi Sankyo Inc., Eli Lilly and Company, Medtronic, Sanofi-Synthelabo

Countries where clinical trial is conducted

United States,  Australia,  Czech Republic,  France,  Germany,  Hungary,  New Zealand,  Poland,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT	The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure.	18 months (12-30 months post-index procedure)	No
Primary	Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT	The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions.	18 months (12-30 months post-index procedure)	No
Primary	GUSTO Severe or Moderate Bleeding - Randomized DES ITT	The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.	18 months (12-30 months post-index procedure)	Yes
Secondary	MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS	Secondary powered endpoint	33 months (0-33 months post-index procedure)	No
Secondary	Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS	Secondary powered endpoint	33 months (0-33 months post-index procedure)	No
Secondary	MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT		21 months (12-33 months post-index procedure)	No
Secondary	Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT	ST was assessed according to the Academic Research Consortium (ARC) definitions.	21 months (12-33 months post-index procedure)	No
Secondary	GUSTO Severe or Moderate Bleeding - Randomized DES ITT	Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.	21 months (12-33 months post-index procedure)	Yes
Secondary	MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT		18 months (12-30 months post-index procedure)	No
Secondary	Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT	ST was assessed according to the Academic Research Consortium (ARC) definitions.	18 months (12-30 months post-index procedure)	No
Secondary	GUSTO Severe or Moderate Bleeding - Randomized BMS ITT	Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.	18 months (12-30 months post-index procedure)	Yes
Secondary	MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT		21 months (12-33 months post-index procedure)	No
Secondary	Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT	ST was assessed according to the Academic Research Consortium (ARC) definitions.	21 months (12-33 months post-index procedure)	No
Secondary	GUSTO Severe or Moderate Bleeding - Randomized BMS ITT	Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.	21 months (12-33 months post-index procedure)	Yes