Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.
Department of Cardiology, Beijing Jishuitan Hospital, The Fourth Clinical Medical College of Peking University, Beijing, China.
Br J Clin Pharmacol. 2022 Feb;88(2):490-499. doi: 10.1111/bcp.15004. Epub 2021 Aug 16.
Thrombolytic therapy has been known to be effective in reducing clinical outcomes and increasing recanalization rate among patients with ST-segment elevation acute myocardial infarction (STEMI). However, whether post-thrombolysis recanalization could be used as a surrogate for clinical outcomes is unknown.
We systematically searched PubMed, EMBASE and the Cochrane Library database to identify randomized controlled trials (RCT) that examined effects of thrombolytic agents in STEMI. Recanalization was defined as TIMI grade 2 or 3 flow. The primary outcome was in-hospital all-cause mortality. Secondary outcomes included in-hospital and 30-day recurrent myocardial infarction (re-MI), composite of death and re-MI, major bleeding and all bleeding. Random-effects meta-regression was used for analysis.
We identified 111 eligible study arms and 52 eligible comparisons from 58 RCTs involving 16 536 patients. Our analyses showed that among study arms recanalization rate was significantly inversely associated with the incidence of in-hospital all-cause mortality (β: -0.07, 95% confidence interval [CI]: -0.13 to -0.02), re-MI (β: -0.09, 95%CI: -0.18 to -0.01) and the composite of death and re-MI (β: -0.17, 95%CI: -0.28 to -0.05), and positively associated with in-hospital all bleeding but not with major bleeding. Among paired comparisons, the difference in recanalization rate was associated with the corresponding difference in incidence of in-hospital all-cause mortality (β: -0.15, 95%CI: -0.28 to -0.01) but the relationship was not significant for any other outcome.
Pooled evidence from RCTs suggest the potential use of recanalization as a surrogate for clinical outcomes in evaluating the efficacy of thrombolysis among patients with STEMI.
溶栓治疗已被证实可有效降低 ST 段抬高型急性心肌梗死（STEMI）患者的临床结局并提高再通率。然而，溶栓后再通是否可作为临床结局的替代指标尚不清楚。
我们系统地检索了 PubMed、EMBASE 和 Cochrane 图书馆数据库，以确定评估溶栓药物治疗 STEMI 效果的随机对照试验（RCT）。再通定义为 TIMI 血流分级 2 或 3 级。主要结局为住院期间全因死亡率。次要结局包括住院期间和 30 天内复发性心肌梗死（re-MI）、死亡和再-MI 复合事件、大出血和所有出血。采用随机效应荟萃回归进行分析。
我们从 58 项 RCT 中确定了 111 个研究臂和 52 个研究臂比较，共涉及 16536 例患者。我们的分析表明，研究臂的再通率与住院期间全因死亡率（β：-0.07，95%置信区间 [CI]：-0.13 至 -0.02）、再-MI（β：-0.09，95%CI：-0.18 至 -0.01）和死亡和再-MI 复合事件（β：-0.17，95%CI：-0.28 至 -0.05）的发生率呈显著负相关，与住院期间全出血呈正相关，但与大出血无关。在配对比较中，再通率的差异与住院期间全因死亡率的相应差异相关（β：-0.15，95%CI：-0.28 至 -0.01），但对于其他任何结局，这种关系均不显著。
RCT 的汇总证据表明，再通率可能可作为评价 STEMI 患者溶栓疗效的临床结局替代指标。
