Widimský P, Budesínský T, Vorác D, Groch L, Zelízko M, Aschermann M, Branny M, St'ásek J, Formánek P
Cardiocenter Vinohardy, Prague, Czech Republic.
Eur Heart J. 2003 Jan;24(1):94-104. doi: 10.1016/s0195-668x(02)00468-2.
Primary percutaneous coronary intervention (PCI) is shown to be the most effective reperfusion strategy in acute myocardial infarction. The aim of this multicentre national randomized mortality trial was to test whether the nationwide change in treatment guidelines (transportation of all patients to PCI centres) was warranted.
The PRAGUE-2 study randomized 850 patients with acute ST elevation myocardial infarction presenting within <12 h to the nearest community hospital without a catheter laboratory to either thrombolysis in this hospital (TL group, n=421) or immediate transport for primary percutaneous coronary intervention (PCI group, n=429). The primary end-point was 30-day mortality. Secondary end-points were: death/reinfarction/stroke at 30 days (combined end-point) and 30-day mortality among patients treated within 0-3 h and 3-12 h after symptom onset. Maximum transport distance was 120 km.
Five complications (1.2%) occurred during the transport. Randomization-balloon time in the PCI group was 97+/-27 min, and randomization-needle time in the TL group was 12+/-10 min. Mortality at 30 days was 10.0% in the TL group compared to 6.8% mortality in the PCI group (P=0.12, intention-to-treat analysis). Mortality of 380 patients who actually underwent PCI was 6.0% vs 10.4% mortality in 424 patients who finally received TL (P<0.05). Among 299 patients randomized >3 h after the onset of symptoms, the mortality of the TL group reached 15.3% compared to 6% in the PCI group (P<0.02). Patients randomized within <3 h of symptom onset (n=551) had no difference in mortality whether treated by TL (7.4%) or transferred to PCI (7.3%). A combined end-point occurred in 15.2% of the TL group vs 8.4% of the PCI group (P<0.003).
Long distance transport from a community hospital to a tertiary PCI centre in the acute phase of AMI is safe. This strategy markedly decreases mortality in patients presenting >3 h after symptom onset. For patients presenting within <3 h of symptoms, TL results are similar results to long distance transport for PCI.
在急性心肌梗死中，直接经皮冠状动脉介入治疗（PCI）被证明是最有效的再灌注策略。这项多中心全国随机死亡率试验的目的是检验全国治疗指南的改变（将所有患者转运至PCI中心）是否合理。
PRAGUE - 2研究将850例发病时间<12小时、就诊于最近的无导管实验室的社区医院的急性ST段抬高型心肌梗死患者随机分为两组，一组在该医院进行溶栓治疗（TL组，n = 421），另一组立即转运至行直接经皮冠状动脉介入治疗（PCI组，n = 429）。主要终点是30天死亡率。次要终点包括：30天的死亡/再梗死/卒中（联合终点）以及症状发作后0 - 3小时和3 - 12小时内接受治疗患者的30天死亡率。最大转运距离为120公里。
转运过程中发生5例并发症（1.2%）。PCI组随机分组至球囊扩张时间为97±27分钟，TL组随机分组至穿刺时间为12±10分钟。TL组30天死亡率为10.0%，PCI组为6.8%（意向性分析，P = 0.12）。实际接受PCI治疗的380例患者死亡率为6.0%，而最终接受溶栓治疗的424例患者死亡率为10.4%（P<0.05）。在症状发作>3小时后随机分组的299例患者中，TL组死亡率达15.3%，而PCI组为6%（P<0.02）。症状发作<3小时内随机分组的患者（n = 551），无论接受溶栓治疗（7.4%）还是转运至PCI治疗（7.3%），死亡率无差异。联合终点在TL组发生率为15.2%，PCI组为8.4%（P<0.003）。
在急性心肌梗死急性期，从社区医院长途转运至三级PCI中心是安全的。该策略显著降低了症状发作>3小时患者的死亡率。对于症状发作<3小时的患者，溶栓治疗与长途转运至PCI治疗的效果相似。
