The primary objectives of the trial are: 1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing a primary angioplasty strategy. 2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™ stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.
Prospective, 2 x 2 factorial single blind, randomized, multi-center trial of 3400 patients enrolled at up to 200 centers. Patients will be randomized 1:1 in the emergency room to a) anticoagulation with unfractionated heparin plus routine GP IIb/IIIa inhibition vs. b) bivalirudin and bail-out GP IIb/IIIa inhibition. Following angiography, patients with lesions eligible for stenting will then undergo a second randomization (3:1) to stent implantation with either a) a slow rate-release paclitaxel-eluting stent (TAXUS™) or b) an otherwise identical uncoated bare metal stent (EXPRESS2™).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3,602
Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
Uncoated bare metal stent
LeBauer CV Research Foundation
Greensboro, North Carolina, United States
Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).
Time frame: 30 Days
Stent Arm - Ischemic Target Lesion Revascularization
Number of Participants With Ischemic Target Lesion Revascularization
Time frame: 1 year
Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis
Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis
Time frame: 1 year
Pharmacology Arm - Major Adverse Cardiovascular Events
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)
Time frame: 30 days
Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding
Number of participants with major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting)
Time frame: 30 days
Stent Arm - Segment Binary Angiographic Restenosis
Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset).
Time frame: 13 months
Pharmacology Arm - Major Adverse Cardiovascular Events
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)
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slow rate-release paclitaxel-eluting stent
Time frame: 3 years