Conditions: Myocardial Infarction
Keywords: Myocardial Infarction Angioplasty Myocardial Ischemia Myocardial Reperfusion Stents Heart Disease
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 3602
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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™).

Arms:
arm 1: To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:

1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days. arm 2: To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:

1. reduced rates of target lesion revascularization for ischemia at 1 year
2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
3. lower rates of analysis segment binary angiographic restenosis at 13 months

Interventions: intervention 1: Bivalirudin intervention 2: Unfractionated heparin intervention 3: Bare metal stent intervention 4: Paclitaxel-eluting stent
Intervention descriptions: intervention 1: 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). intervention 2: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room). intervention 3: Uncoated bare metal stent intervention 4: slow rate-release paclitaxel-eluting stent

Protocol document: