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急性心肌梗死中直接血管成形术与院前溶栓治疗比较(CAPTIM)试验:5年随访

Comparison of primary angioplasty and pre-hospital fibrinolysis in acute myocardial infarction (CAPTIM) trial: a 5-year follow-up.

作者信息

Bonnefoy Eric, Steg Philippe Gabriel, Boutitie Florent, Dubien Pierre-Yves, Lapostolle Frédéric, Roncalli Jérome, Dissait Frederic, Vanzetto Gérald, Leizorowicz Alain, Kirkorian Gilbert, Mercier C, McFadden E P, Touboul P

机构信息

UMR 5558, Univeristé Lyon 1 et Centre d'Investigation Clinique, Hôpital Cardio-Vasculaire et Pneumologique, Hospices Civils de Lyon, 69394 Lyon Cedex 03, France.

出版信息

Eur Heart J. 2009 Jul;30(13):1598-606. doi: 10.1093/eurheartj/ehp156. Epub 2009 May 8.

Abstract

AIMS

The CAPTIM (Comparison of primary Angioplasty and Pre-hospital fibrinolysis In acute Myocardial infarction) study found no evidence that a strategy of primary angioplasty was superior in terms of 30-day outcomes to a strategy of pre-hospital fibrinolysis with transfer to an interventional facility in patients managed early at the acute phase of an acute myocardial infarction. The present analysis was designed to compare both strategies at 5 years.

METHODS AND RESULTS

The CAPTIM study included 840 patients managed in a pre-hospital setting within 6 h of an acute ST-segment elevation myocardial infarction. Patients were randomized to either a primary angioplasty (n = 421) or a pre-hospital fibrinolysis (rt-PA) with immediate transfer to a centre with interventional facilities (n = 419). Long-term follow-up was obtained in blinded fashion from 795 patients (94.6%). Using an intent-to-treat analysis, all-cause mortality at 5 years was 9.7% in the pre-hospital fibrinolysis group when compared with 12.6% in the primary angioplasty group [HR 0.75 (95% CI, 0.50-1.14); P = 0.18]. For patients included within 2 h, 5 year mortality was 5.8% in the pre-hospital fibrinolysis group when compared with 11.1% in the primary angioplasty group [HR 0.50 (95% CI, 0.25-0.97); P = 0.04], whereas it was, respectively, 14.5 and 14.4% in patients included after 2 h [HR 1.02, (95% CI 0.59-1.75), P = 0.92].

CONCLUSION

The 5-year follow-up is consistent with the 30-day outcomes of the trial, showing similar mortality for primary percutaneous coronary intervention and a policy of pre-hospital lysis followed by transfer to an interventional center. In addition, for patients treated within 2 h of symptom onset, 5-year mortality was lower with pre-hospital lysis.

摘要

目的

CAPTIM(急性心肌梗死中直接血管成形术与院前溶栓治疗的比较)研究发现,没有证据表明在急性心肌梗死急性期早期治疗的患者中,直接血管成形术策略在30天预后方面优于院前溶栓并转运至介入治疗机构的策略。本分析旨在比较两种策略在5年时的情况。

方法与结果

CAPTIM研究纳入了840例在急性ST段抬高型心肌梗死6小时内进行院前治疗的患者。患者被随机分为直接血管成形术组(n = 421)或院前溶栓(rt-PA)并立即转运至有介入治疗设施的中心组(n = 419)。以盲法对795例患者(94.6%)进行了长期随访。采用意向性分析,院前溶栓组5年全因死亡率为9.7%,而直接血管成形术组为12.6%[风险比0.75(95%可信区间,0.50 - 1.14);P = 0.18]。对于在2小时内纳入的患者,院前溶栓组5年死亡率为5.8%,而直接血管成形术组为11.1%[风险比0.50(95%可信区间,0.25 - 0.97);P = 0.04],而在2小时后纳入的患者中,死亡率分别为14.5%和14.4%[风险比1.02,(95%可信区间0.59 - 1.75),P = 0.92]。

结论

5年随访结果与试验的30天预后一致,显示直接经皮冠状动脉介入治疗与院前溶栓后转运至介入中心的策略死亡率相似。此外,对于症状发作2小时内接受治疗的患者,院前溶栓的5年死亡率较低。

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