Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial.

摘要: ContextEnoxaparin has demonstrated advantages over unfractionated heparin in low- to moderate-risk patients with non–ST-segment elevation acute coronary syndromes (ACS) treated a conservative strategy.ObjectivesTo compare the outcomes of enoxaparin vs unfractionated heparin and define role in non–ST-segment elevation ACS at high risk for ischemic cardiac complications managed with an early invasive approach.Design, Setting, ParticipantsThe Superior Yield New Strategy Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial was prospective, randomized, open-label, multicenter, international conducted between August 2001 and December 2003. A total 10 027 high-risk be an intended strategy were recruited.InterventionsSubcutaneous (n = 4993) or intravenous heparin (n 4985) administered immediately after enrollment continued until patient required no further anticoagulation, as judged by treating physician.Main Outcome MeasuresThe primary efficacy outcome composite clinical end point of all-cause death nonfatal myocardial infarction during first 30 days after randomization. The safety major bleeding stroke.ResultsThe occurred 14.0% (696/4993) assigned to 14.5% (722/4985) assigned (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.86-1.06). No differences events percutaneous coronary intervention (PCI) were observed groups, respectively, including similar rates abrupt closure (31/2321 [1.3%] vs 40/2364 [1.7%]), threatened (25/2321 [1.1%] 24/2363 [1.0%]), unsuccessful PCI (81/2281 [3.6%] 79/2328 [3.4%]), emergency coronary artery bypass graft surgery (6/2323 [0.3%] 8/2363 [0.3%]). More bleeding was enoxaparin, statistically significant increase in TIMI (Thrombolysis Myocardial Infarction) (9.1% 7.6%, P .008) but nonsignificant excess GUSTO (Global Utilization of Streptokinase t-PA Occluded Arteries) severe (2.7% vs 2.2%, .08) transfusions (17.0% 16.0%, .16).ConclusionsEnoxaparin not superior noninferior for treatment elevation ACS. Enoxaparin is safe effective alternative heparin and convenience should balanced modest excess of bleeding.