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行溶栓治疗的 ST 段抬高型心肌梗死患者中应用依诺肝素与未分级肝素的策略 1 年后的结果:EXTRACT-TIMI 25 试验 1 年结果。

One-year outcomes after a strategy using enoxaparin vs. unfractionated heparin in patients undergoing fibrinolysis for ST-segment elevation myocardial infarction: 1-year results of the ExTRACT-TIMI 25 trial.

机构信息

TIMI Study Group/Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.

出版信息

Eur Heart J. 2010 Sep;31(17):2097-102. doi: 10.1093/eurheartj/ehq098. Epub 2010 Apr 17.

Abstract

AIMS

To determine the impact of a strategy using enoxaparin for up to 8 days compared with unfractionated heparin (UFH) for 48 h as an adjunct to fibrinolysis for ST-segment elevation myocardial infarction (STEMI) on 1-year clinical outcomes.

METHODS AND RESULTS

Follow-up at 1 year (n = 20 275) was conducted by telephone in the ExTRACT-TIMI 25 trial to ascertain the endpoints of death, MI, and disabling stroke. The primary endpoint of death or non-fatal MI occurred in 1614 (15.8%) and 1732 (17.0%) of patients allocated to enoxaparin and UFH, respectively [hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.86-0.98, P = 0.01]. The enoxaparin strategy significantly reduced non-fatal MI at 1 year (5.7 vs. 6.8%, HR 0.82, 95% CI 0.73-0.92, P < 0.001). The risks of death (10.5 vs. 10.6%, HR 0.98, 95% CI 0.91-1.07) and disabling stroke (1.1 vs. 1.2%, HR 0.97, 95% CI 0.75-1.26) were not reduced. The composite of death, MI, or disabling stroke favoured enoxaparin (HR 0.91, 95% CI 0.85-0.98, P = 0.007).

CONCLUSION

Compared with UFH for 48 h, a strategy using enoxaparin as an adjunct to fibrinolysis resulted in a sustained reduction in death or MI at 1 year with no additional benefit after 30 days. Mortality was not reduced at 1 year with the enoxaparin strategy. The study was registered at ClinicalTrials.gov, NCT00077792.

摘要

目的

确定与使用普通肝素(UFH)48 小时相比,使用依诺肝素长达 8 天作为溶栓治疗 ST 段抬高型心肌梗死(STEMI)的辅助治疗对 1 年临床结局的影响。

方法和结果

在 EXTRACT-TIMI 25 试验中,通过电话对 20275 例患者进行了 1 年的随访,以确定死亡、心肌梗死和致残性卒中的终点。依诺肝素组和 UFH 组分别有 1614 例(15.8%)和 1732 例(17.0%)患者发生死亡或非致死性心肌梗死[风险比(HR)0.92,95%置信区间(CI)0.86-0.98,P=0.01]。依诺肝素治疗策略显著降低了 1 年时的非致死性心肌梗死风险(5.7% vs. 6.8%,HR 0.82,95%CI 0.73-0.92,P<0.001)。死亡风险(10.5% vs. 10.6%,HR 0.98,95%CI 0.91-1.07)和致残性卒中风险(1.1% vs. 1.2%,HR 0.97,95%CI 0.75-1.26)未降低。死亡、心肌梗死或致残性卒中的复合终点更有利于依诺肝素(HR 0.91,95%CI 0.85-0.98,P=0.007)。

结论

与 UFH 48 小时相比,依诺肝素作为溶栓治疗的辅助治疗策略可在 1 年内持续降低死亡或心肌梗死风险,在 30 天后无额外获益。依诺肝素策略在 1 年内未降低死亡率。本研究在 ClinicalTrials.gov 注册,NCT00077792。

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