• Composite of major adverse ischemic cardiac events + major bleeding at 30 days
• Ischemic target lesion revascularization at 1 year
• Composite rate of death, reinfarction, stroke or stent thrombosis at 1 year

• Composite of major adverse ischemic cardiac events + major bleeding at 30 days
• Ischemic target lesion revascularization at 1 year
• Composite rate of death, reinfarction, stroke or stent thrombosis at 1 year

• Major bleeding events at 30 days
• Major adverse ischemic cardiac events at 30 days
• Analysis segment binary angiographic restenosis at 13 months

• Major bleeding events at 30 days
• Major adverse ischemic cardiac events at 30 days
• Analysis segment binary angiographic restenosis at 13 months

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.

• Drug: Bivalirudin
• Drug: Unfractionated heparin
• Device: Uncoated bare metal stent (EXPRESS2™)
• Device: Paclitaxel-eluting stent (TAXUS™)

• Stone GW, Lansky AJ, Pocock SJ, Gersh BJ, Dangas G, Wong SC, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Möckel M, Ochala A, Kellock A, Parise H, Mehran R; HORIZONS-AMI Trial Investigators. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med. 2009 May 7;360(19):1946-59.
• Mehran R, Brodie B, Cox DA, Grines CL, Rutherford B, Bhatt DL, Dangas G, Feit F, Ohman EM, Parise H, Fahy M, Lansky AJ, Stone GW. The Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: study design and rationale. Am Heart J. 2008 Jul;156(1):44-56.
• Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Kirtane AJ, Parise H, Mehran R; HORIZONS-AMI Trial Investigators. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008 May 22;358(21):2218-30.

Inclusion Criteria:

• Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent)lasting >20 minutes but <12 hours in duration;
• ST-segment elevation of >1 mm in >2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1 mm in >2 contiguous anterior leads;
• The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent.

Exclusion Criteria:

• The patient has a known hypersensitivity or contraindication to any of the following medications:

  • Heparin, pork or pork products
  • Both abciximab and eptifibatide
  • Aspirin
  • Both Clopidogrel and Ticlopidine
  • Bivalirudin
  • Paclitaxel or Taxol
  • The polymer components of the TAXUS™ stent (SIBS)
  • Stainless steel and/or
  • Contrast media;
• Prior administration of thrombolytic therapy, bivalirudin, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for this admission.

Patients receiving prior unfractionated heparin may be enrolled, and treated per randomization;

• Current use of coumadin;
• Systemic (intravenous) Paclitaxel or Taxol use within 12 months;
• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study;
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
• History of intra-cerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;
• Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;
• Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;
• Recent history or known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL;
• Extensive peripheral vascular disease, such that emergent angiography and intervention in the opinion of the investigator is likely to be difficult or complicated;
• An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment;
• Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance;
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
• Previous enrollment in this trial;
• Patients who underwent coronary stent implantation within the past 30 days.

• Boston Scientific Corporation
• The Medicines Company