Division of Cardiology, West Virginia University School of Medicine, 1 Medical Center Drive, Morgantown, WV, 26506, USA.
Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.
J Thromb Thrombolysis. 2019 Nov;48(4):661-667. doi: 10.1007/s11239-019-01953-3.
Few randomized controlled trials (RCTs) have compared ticagrelor to clopidogrel after thrombolytic therapy in patients with ST-segment elevation myocardial infarction (STEMI). To assess the quality of the current evidence, a trial sequential analysis (TSA) of all the available RCTs was performed. A literature search through electronic databases for relevant RCTs was completed. Trial sequential boundaries were applied to the meta-analysis to guard against statistical error, calculate the information size (IS), and assess the quality of the currently available evidence. The safety outcome was bleeding at 30-days and the efficacy outcome was major adverse cardiovascular events at 30-days. There were 3 RCTs with a total of 3999 patients were included. For the safety and efficacy outcomes, there was no difference between the ticagrelor and clopidogrel groups (RR 0.94; 95% CI 0.56-1.60, p = 0.83) and (RR 0.87; 95% CI 0.49-1.52, p = 0.62), respectively. The corresponding TSA revealed an IS of 20,928 and 37,266 for safety and efficacy outcomes, respectively. The Z-curves for both outcomes failed to cross the conventional boundary of significance and TSA boundary, indicating no statistical difference between the ticagrelor and clopidogrel group and lack of firm evidence from the currently available RCTs to draw conclusion. Based on the current available RCTs, there is not enough evidence to support or refute better outcomes with ticagrelor in patients with STEMI treated with thrombolytics. Larger RCTs with enough power are needed before firm recommendations can be applied.
在 ST 段抬高型心肌梗死(STEMI)患者中,溶栓治疗后比较替格瑞洛和氯吡格雷的随机对照试验(RCT)很少。为了评估当前证据的质量,对所有可用 RCT 进行了试验序贯分析(TSA)。通过电子数据库对相关 RCT 进行了文献检索。应用试验序贯边界对荟萃分析进行分析,以防止统计学误差,计算信息大小(IS),并评估当前可用证据的质量。安全性结局为 30 天内出血,疗效结局为 30 天内主要不良心血管事件。有 3 项 RCT 共纳入 3999 例患者。对于安全性和疗效结局,替格瑞洛组和氯吡格雷组之间无差异(RR 0.94;95%CI 0.56-1.60,p=0.83)和(RR 0.87;95%CI 0.49-1.52,p=0.62)。相应的 TSA 显示安全性和疗效结局的 IS 分别为 20928 和 37266。两个结局的 Z 曲线均未穿过传统的显著性边界和 TSA 边界,表明替格瑞洛组和氯吡格雷组之间无统计学差异,并且目前可用 RCT 缺乏确凿证据来得出结论。基于目前可用的 RCT,没有足够的证据支持或反驳替格瑞洛在接受溶栓治疗的 STEMI 患者中具有更好的结局。在能够得出确定结论之前,需要进行具有足够效力的更大 RCT。