harmonizing outcomes with revascularization and stents in acute myocardial infarction

Conditions: Myocardial Infarction

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.

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™).

Eligibility criteria:
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.

Keywords: myocardial infarction angioplasty myocardial ischemia myocardial reperfusion stents heart disease