Study Design

• Randomized
• Parallel

Patient Populations:

• ≥18 years of age
• Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia including chronic stable CAD, or acute coronary syndrome including non-ST-elevation and ST-elevation MI
• Acceptable candidate for coronary artery bypass grafting
• At least one lesion with a diameter stenosis >70% or more suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm
• Patients with multilesion or multivessel coronary disease, must have successful treatment (<30% diameter stenosis visual estimate) of the first treated lesion prior to treatment of other lesions at the same brand of stent; staged (planned) procedures must be performed within 30 days of the index procedure
  
  Number of enrollees: 2,737
  Duration of follow-up: 1 year
  Mean patient age: 60.2 years
  Percentage female: 31%
  Left ventricular ejection fraction: 61%

Exclusions:

• Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with DAPT for at least 1 year
• Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate), or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause noncompliance with the protocol, confound the data interpretation, or is associated with a limited life expectancy (i.e., <1 year)
• Left ventricular function <40%
• Cardiogenic shock or hemodynamic compromise requiring pressors and/or inotropes or mechanical support
• Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, Rapamycinry, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately premedicated 
• Existing impairment in liver and kidney
• Extremely tortuous and/or calcification lesions
• Two or more chronic total occlusions in the proximal half of the epicardial coronary artery that cannot be recannalized

Primary Endpoints:

• One-year TLF (composite of cardiac death, target vessel MI, and clinically indicated TLR)

Secondary Endpoints:

• One-year TLF and net adverse clinical cardiovascular event (NACCE) (composite of death, MI, stroke, major bleeding (Bleeding Academic Research Consortium [BARC] ≥ II) between 6- and 12-month DAPT groups after BP-SES implantations
• Individual TLF components, definite/probable stent thrombosis, device/lesion/procedure success rates, and composite of all-cause death, all MI, and any revascularization

Drug/Procedures Used:

Patients were randomized in a 2:1 fashion to receive either BP-DES or DP-DES. Patients in the BP-DES arm were further randomized to either 6 or 12 months of DAPT.

Concomitant Medications:

A loading dose of 300 mg of aspirin and 300 mg of clopidogrel was administered before all procedures. All patients were discharged with a prescription for at least 100 mg of aspirin indefinitely and 75 mg of clopidogrel for a minimum of 6 months after index procedure.