Widimsky Petr, Bilkova Dana, Penicka Martin, Novak Martin, Lanikova Miroslava, Porizka Vladimir, Groch Ladislav, Zelizko Michael, Budesinsky Tomas, Aschermann Michael
Cardiocenter Vinohrady, Third Faculty of Medicine, Charles University, Srobarova 50, Prague, Czech Republic.
Eur Heart J. 2007 Mar;28(6):679-84. doi: 10.1093/eurheartj/ehl535. Epub 2007 Feb 13.
Randomized trials in ST-elevation myocardial infarction (STEMI) showed improved early outcomes after primary percutaneous coronary intervention (p-PCI) compared with thrombolysis (TL). It is less known whether the early benefit is sustained during the long-term follow-up.
The PRAGUE-2 trial enrolled 850 STEMI patients presenting to community hospitals without cath-labs within 12 h of symptom onset. Patients were randomized into the groups 'TL in community hospital' (n = 421) and 'interhospital transfer for p-PCI' (n = 429). Follow-up data were available in 416 (98.8%) patients in the TL group and 428 (99.8%) in the p-PCI group. At 5 year follow-up, the cumulative incidence of composite endpoint (death from any cause or recurrent infarction or stroke or revascularization) was 53% in TL patients compared with 40% in p-PCI patients (HR 1.8; 95% CI 1.38-2.33; P < 0.001). The respective cumulative incidence of death from any cause was 23 and 19% (HR 1.34; 95% CI 0.99-1.82; P = 0.06), recurrent infarction 19 vs. 12% (HR 1.72; 95% CI 1.15-2.58; P = 0.009), stroke 8 vs. 8% (HR 1.65; 95% CI 0.84-2.23; P = 0.18), revascularization 51 vs. 34% (HR 1.81; 95% CI 1.21-2.35; P < 0.001).
The early benefit from the p-PCI strategy (over TL) is sustained during the 5 years' follow-up. It can be almost exclusively derived from differences in event rate during the first month.
在ST段抬高型心肌梗死(STEMI)的随机试验中,与溶栓治疗(TL)相比,直接经皮冠状动脉介入治疗(p-PCI)显示早期预后得到改善。但早期获益在长期随访中是否持续尚鲜为人知。
PRAGUE-2试验纳入了850例症状发作12小时内就诊于无导管室的社区医院的STEMI患者。患者被随机分为“社区医院溶栓治疗”组(n = 421)和“转院进行p-PCI”组(n = 429)。TL组416例(98.8%)患者和p-PCI组428例(99.8%)患者有随访数据。在5年随访时,TL组患者复合终点(任何原因导致的死亡或再发梗死或中风或血运重建)的累积发生率为53%,而p-PCI组为40%(风险比1.8;95%置信区间1.38 - 2.33;P < 0.001)。任何原因导致的死亡的各自累积发生率分别为23%和19%(风险比1.34;95%置信区间0.99 - 1.82;P = 0.06),再发梗死为19%对12%(风险比1.72;95%置信区间1.15 - 2.58;P = 0.009),中风为8%对8%(风险比1.65;95%置信区间0.84 - 2.23;P = 0.18),血运重建为51%对34%(风险比1.81;95%置信区间1.21 - 2.35;P < 0.001)。
p-PCI策略(优于TL)的早期获益在5年随访中得以持续。这几乎完全源于第一个月内事件发生率的差异。