Department of Cardiology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, France (N.D., E.P.).
Université Paris-Descartes, France (N.D., E.P.).
Circ Cardiovasc Interv. 2018 Sep;11(9):e007241. doi: 10.1161/CIRCINTERVENTIONS.118.007241.
Background The optimal timing of administration of dual antiplatelet therapy (DAPT) in acute ST-segment-elevation myocardial infarction patients is debated. Clinical trials have failed to demonstrate the superiority of pretreatment with P2Y12 inhibitors in ST-segment-elevation myocardial infarction, but they were not designed to assess hard clinical end points. We used data from the FAST-MI (French Registry on Acute ST-Segment-Elevation or Non-ST-Segment-Elevation Myocardial Infarction) cohorts to determine 1-year survival and in-hospital outcomes in patients receiving DAPT, comparing prehospital versus in-hospital administration. Methods and Results The FAST-MI program collects extensive data on patients admitted in France for acute myocardial infarction over a 1-month period every 5 years since 2005. For the present analysis, 3548 patients with ST-segment-elevation myocardial infarction ≤12 hours from symptom onset, transported by physician-staffed emergency medical system ambulances, not treated with intravenous fibrinolysis, and receiving DAPT were included, of whom 44% received DAPT in the ambulance. The primary end point was 1-year survival as assessed by multivariate Cox analysis and propensity score analysis. In-hospital bleeding and ischemic complications were also analyzed. Adjusted in-hospital mortality was numerically but not significantly lower in patients with prehospital DAPT. There were no differences in in-hospital bleeding complications. Fully-adjusted hazard ratio for 1-year death in patients with prehospital versus in-hospital DAPT was 0.69 (95% CI, 0.51-0.92; P=0.011), and propensity score-adjusted hazard ratio was 0.55 (95% CI, 0.41-0.73; P=0.001) in the whole population. In the propensity score-matched cohorts (360 patients each), 1-year survival was 93.9% in patients with prehospital versus 90.3% in those with in-hospital DAPT (hazard ratio, 0.62; 95% CI, 0.36-1.05; P=0.077). Results were consistent in subgroups, including by year of survey, age, presence of out-of-hospital cardiac arrest, morphine use, and type of P2Y12 inhibitor used. Conclusions In these cohorts of ST-segment-elevation myocardial infarction patients considered for primary percutaneous coronary intervention, prehospital administration of DAPT was associated with higher 1-year survival and no increase in in-hospital bleeding complications. The magnitude of the decrease in 1-year mortality, however, may suggest the persistence of some degree of residual confounding. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifiers: NCT00673036, NCT01237418, and NCT02566200.
背景 急性 ST 段抬高型心肌梗死患者双联抗血小板治疗(DAPT)的最佳给药时机仍存在争议。临床试验未能证明 ST 段抬高型心肌梗死患者预先使用 P2Y12 抑制剂具有优势,但这些试验并非专门用于评估硬终点临床结局。我们利用 FAST-MI(法国急性 ST 段抬高或非 ST 段抬高型心肌梗死注册研究)队列的数据,评估了在接受 DAPT 的患者中,院前与院内给药的 1 年生存率和院内结局。
方法和结果 FAST-MI 方案在 2005 年以来的每 5 年 1 个月内,收集法国因急性心肌梗死入院患者的广泛数据。本分析纳入了 3548 例症状发作 12 小时内的 ST 段抬高型心肌梗死患者,由配备医生的急救医疗系统救护车转运,未接受静脉溶栓治疗,且接受 DAPT 治疗,其中 44%的患者在救护车上接受 DAPT。主要终点为多变量 Cox 分析和倾向评分分析评估的 1 年生存率。同时分析院内出血和缺血性并发症。校正后的院内死亡率在院前 DAPT 组略有降低,但无统计学意义。院内出血并发症无差异。与院内 DAPT 相比,院前 DAPT 的患者 1 年死亡的全调整危险比为 0.69(95%CI,0.510.92;P=0.011),经倾向评分调整的危险比为 0.55(95%CI,0.410.73;P=0.001)。在整个队列和倾向评分匹配队列(每组 360 例)中,院前 DAPT 的患者 1 年生存率为 93.9%,而院内 DAPT 的患者为 90.3%(危险比,0.62;95%CI,0.36~1.05;P=0.077)。亚组分析结果一致,包括按调查年份、年龄、院外心脏骤停、吗啡使用和 P2Y12 抑制剂类型等分层因素。
结论 在这些考虑行直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者中,院前给予 DAPT 可提高 1 年生存率,且不增加院内出血并发症。然而,1 年死亡率的降低幅度可能提示仍存在一定程度的残余混杂。
URL:https://www.clinicaltrials.gov。唯一标识符:NCT00673036、NCT01237418 和 NCT02566200。