Context: Enoxaparin has demonstrated advantages over unfractionated hep arin in low-to moderate-risk patients with non-ST-segment elevation acute coronary syndromes (ACS) treated with a conservative strategy. Objectiv...Context: Enoxaparin has demonstrated advantages over unfractionated hep arin in low-to moderate-risk patients with non-ST-segment elevation acute coronary syndromes (ACS) treated with a conservative strategy. Objectives: To compare the outcomes of patients treated with enoxaparin vs unfractionated hep arin and to define the role of enoxaparin in patients with non-ST-segment elev ation ACS at high risk for ischemic cardiac complications managed with an early invasive approach. Design, Setting, and Participants: The Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibito rs (SYNERGY) trial was a prospective, randomized, open-label, multicenter, inte rnational trial conducted between August 2001 and December 2003. A total of 1002 7 high-risk patients with non-ST-segment elevation ACS to be treated with an intended early invasive strategy were recruited. Interventions: Subcutaneous eno xaparin (n=4993) or intravenous unfractionated heparin (n=4985) was to be admini stered immediately after enrollment and continued until the patient required no further anticoagulation, as judged by the treating physician. Main Outcome Measu res: The primary efficacy outcome was the composite clinical end point of all-c ause death or nonfatal myocardial infarction during the first 30 days after rand omization. The primary safety outcome was major bleeding or stroke. Results: The primary end point occurred in 14.0%(696/4993) of patients assigned to enoxapar in and 14.5%(722/4985) of patients assigned to unfractionated heparin (odds rat io <<OR>>, 0.96; 95%confidence interval <<CI>>, 0.86-1,06). No differences in isch emic events during percutaneous coronary intervention (PCI) were observed betwee n enoxaparin and unfractionated heparin groups, respectively, including similar rates of abrupt closure (31/2321 <<1.3%>> vs 40/2364 <<1.7%>>), threatened abrupt closure (25/2321 <<1.1%>> vs 24/2363 <<1.0%>>), unsuccessful PCI (81/2281 <<3.6%>> vs 79/ 2328 <<3.4%>>), or emergency coronary artery bypass graft surgery (6/2323 <<0.3%>> vs 8/2363 <<0.3%>>). More bleeding was observed with enoxaparin, with a s tatistically significant increase in TIMI (Thrombolysis in Myocardial Infarction ) major bleeding (9.1%vs 7.6%, P=.008) but nonsignificant excess in GUSTO (Glo bal Utilization of Streptokinase and t-PA for Occluded Arteries) severe bleedin g (2.7%vs 2.2%, P=.08) and transfusions (17.0%vs 16.0%, P=.16). Conclusions: Enoxaparin was not superior to unfractionated heparin but was non-inferior for the treatment of high-risk patients with non-ST-segment elevation ACS. Enoxa parin is a safe and effective alternative to unfractionated heparin and the adva ntages of convenience should be balanced with the modest excess of major bleedin g.展开更多
EMPA-REG OUTCOME研究结果于9月17日在第51届欧洲糖尿病研究学会年会上公布并同时发表在New England Journal of Medicine杂志。结果表明,治疗心血管事件风险较高的2型糖尿病患者时,标准治疗方案基础上追加勃林格殷格翰和礼来公司的Jard...EMPA-REG OUTCOME研究结果于9月17日在第51届欧洲糖尿病研究学会年会上公布并同时发表在New England Journal of Medicine杂志。结果表明,治疗心血管事件风险较高的2型糖尿病患者时,标准治疗方案基础上追加勃林格殷格翰和礼来公司的Jardiance®(恩格列净)显著降低由心血管死亡、非致死性心梗、非致死性脑卒中组成的复合终点的风险达14%。其中心血管死亡降低38%,非致死性心梗、展开更多
文摘Context: Enoxaparin has demonstrated advantages over unfractionated hep arin in low-to moderate-risk patients with non-ST-segment elevation acute coronary syndromes (ACS) treated with a conservative strategy. Objectives: To compare the outcomes of patients treated with enoxaparin vs unfractionated hep arin and to define the role of enoxaparin in patients with non-ST-segment elev ation ACS at high risk for ischemic cardiac complications managed with an early invasive approach. Design, Setting, and Participants: The Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibito rs (SYNERGY) trial was a prospective, randomized, open-label, multicenter, inte rnational trial conducted between August 2001 and December 2003. A total of 1002 7 high-risk patients with non-ST-segment elevation ACS to be treated with an intended early invasive strategy were recruited. Interventions: Subcutaneous eno xaparin (n=4993) or intravenous unfractionated heparin (n=4985) was to be admini stered immediately after enrollment and continued until the patient required no further anticoagulation, as judged by the treating physician. Main Outcome Measu res: The primary efficacy outcome was the composite clinical end point of all-c ause death or nonfatal myocardial infarction during the first 30 days after rand omization. The primary safety outcome was major bleeding or stroke. Results: The primary end point occurred in 14.0%(696/4993) of patients assigned to enoxapar in and 14.5%(722/4985) of patients assigned to unfractionated heparin (odds rat io <<OR>>, 0.96; 95%confidence interval <<CI>>, 0.86-1,06). No differences in isch emic events during percutaneous coronary intervention (PCI) were observed betwee n enoxaparin and unfractionated heparin groups, respectively, including similar rates of abrupt closure (31/2321 <<1.3%>> vs 40/2364 <<1.7%>>), threatened abrupt closure (25/2321 <<1.1%>> vs 24/2363 <<1.0%>>), unsuccessful PCI (81/2281 <<3.6%>> vs 79/ 2328 <<3.4%>>), or emergency coronary artery bypass graft surgery (6/2323 <<0.3%>> vs 8/2363 <<0.3%>>). More bleeding was observed with enoxaparin, with a s tatistically significant increase in TIMI (Thrombolysis in Myocardial Infarction ) major bleeding (9.1%vs 7.6%, P=.008) but nonsignificant excess in GUSTO (Glo bal Utilization of Streptokinase and t-PA for Occluded Arteries) severe bleedin g (2.7%vs 2.2%, P=.08) and transfusions (17.0%vs 16.0%, P=.16). Conclusions: Enoxaparin was not superior to unfractionated heparin but was non-inferior for the treatment of high-risk patients with non-ST-segment elevation ACS. Enoxa parin is a safe and effective alternative to unfractionated heparin and the adva ntages of convenience should be balanced with the modest excess of major bleedin g.
文摘EMPA-REG OUTCOME研究结果于9月17日在第51届欧洲糖尿病研究学会年会上公布并同时发表在New England Journal of Medicine杂志。结果表明,治疗心血管事件风险较高的2型糖尿病患者时,标准治疗方案基础上追加勃林格殷格翰和礼来公司的Jardiance®(恩格列净)显著降低由心血管死亡、非致死性心梗、非致死性脑卒中组成的复合终点的风险达14%。其中心血管死亡降低38%,非致死性心梗、