Enoxaparin for 7 days was better than unfractionated heparin for 2 days for reducing death and MI but not bleeding in STEMI

摘要

QuestionnnIn patients with ST-elevation myocardial infarction (STEMI), how does enoxaparin compare with unfractionated heparin (UFH) as adjunctive therapy with fibrinolysis for reducing death or MI? nnMethodsnnDesign: Randomized controlled trial (The Enoxaparin and Thrombolysis Reperfusion for Acute MI Treatment–Thrombolysis in MI [ExTRACT-TIMI] 25 study).nnAllocation: Concealed.*nnBlinding: Blinded (clinicians, patients, {data collectors, outcome assessors, and manuscript writers}†).*nnFollow-up period: 30 days.nnSetting: 674 centers in 48 countries.nnPatients: 20 506 patients 18 years of age (median age 60 y, 77% men, 87% white) who had 20 minutes of ischemic symptoms at rest within 6 hours before randomization, and ST-segment elevation 0.1 mV in 2 limb leads, or 0.2 mV in 2 contiguous precordial leads, or left bundle-branch block. Exclusion criteria included cardiogenic shock, contraindications to fibrinolysis, receipt of low-molecular-weight heparin in the previous 8 hours, and renal insufficiency.nnIntervention: Enoxaparin (n= 10 256) or UFH (n= 10 223). The enoxaparin group received placebo UFH plus intravenous (IV) enoxaparin bolus, 30 mg (omitted for patients 75 y) and 1.0 mg/kg subcutaneously every 12 hours for patients < 75 years; or 0.75 mg/kg every 12 hours for patients 75 years; or enoxaparin, 1.0 mg/kg per day for creatinine clearance < 30 mL/min, for 8 days or until discharge. The UFH group received placebo enoxaparin plus IV UFH bolus, 60 U/kg body weight, and 12 U/kg per hour infusion for 48 hours. All patients received fibrinolysis and aspirin.nnOutcomes: A composite endpoint of death or nonfatal MI at 30 days. Secondary outcomes included major bleeding and various composite endpoints.nnPatient follow-up: 99.9% (20 479 in the intention-to-treat analysis).