Tan Guangyi, Chen Jian, Liu Mao, Yeh James, Tang Wenyi, Ke Jianting, Wu Wei
1 Department of Cardiology, the Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai 519000, China ; 2 National Heart and Lung Institute, Imperial College London, London, UK ; 3 Department of Nephrology, the Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai 519000, China.
Cardiovasc Diagn Ther. 2016 Apr;6(2):101-8. doi: 10.21037/cdt.2015.12.04.
Coronary artery disease (CAD) is the leading cause of morbidity and mortality worldwide. Vorapaxar, a protease-activated receptor-1 (PAR-1) antagonist, is a novel antiplatelet agent that may provide us a new way in antithrombotic therapy. Several studies had been conducted to evaluate the efficacy of vorapaxar in the treatment of CAD, but the results were inconsistent. Here a meta-analysis was made to assess the efficacy and safety of vorapaxar in reducing adverse cardiac events in patients with CAD.
A comprehensive literature search was conducted. The primary efficacy endpoint was the major adverse cardiac events, which was defined as a composite of cardiovascular death, myocardial infarction (MI), stroke, urgent coronary revascularization, or recurrent ischemia with rehospitalization. The primary safety endpoint was the composite of major or minor bleeding events. Pooled effects were measured by odds ratios (ORs) with 95% confidence intervals (CIs). A random-effect or fixed model was used in this meta-analysis.
Totally, 31,388 patients from four randomized controlled trials (RCTs) were included in this meta-analysis. Patients who took vorapaxar combined with standard dual anti-platelet therapy (aspirin and thienopyridine) showed a lower incidence in major adverse cardiac events (OR, 0.86, 95% CI: 0.75-0.99, P=0.03), MI (OR, 0.79, 95% CI: 0.67-0.95, P=0.01) and ischemic stroke (OR, 0.72, 95% CI: 0.58-0.89, P=0.003) than those who only took placebo instead. But there was no significant reduction in cardiovascular death (OR, 0.95, 95% CI: 0.82-1.09, P=0.45). Nevertheless, the vorapaxar group were associated with a higher risk of bleeding events (P<0.001).
The result of this meta-analysis indicated that adding vorapaxar to the standard dual anti-platelet therapy may be efficient in reducing the incidence of major adverse cardiac events at the cost of increasing risk of bleeding events.
冠状动脉疾病(CAD)是全球发病和死亡的主要原因。沃拉帕沙是一种蛋白酶激活受体-1(PAR-1)拮抗剂,是一种新型抗血小板药物,可能为我们提供抗血栓治疗的新方法。已经进行了多项研究来评估沃拉帕沙治疗CAD的疗效,但结果并不一致。在此进行一项荟萃分析,以评估沃拉帕沙在降低CAD患者不良心脏事件方面的疗效和安全性。
进行全面的文献检索。主要疗效终点是主要不良心脏事件,定义为心血管死亡、心肌梗死(MI)、中风、紧急冠状动脉血运重建或再住院的复发性缺血的综合。主要安全终点是主要或轻微出血事件的综合。合并效应通过比值比(OR)和95%置信区间(CI)进行测量。本荟萃分析采用随机效应或固定模型。
本荟萃分析共纳入来自四项随机对照试验(RCT)的31388例患者。与仅服用安慰剂的患者相比,服用沃拉帕沙联合标准双联抗血小板治疗(阿司匹林和噻吩并吡啶)的患者发生主要不良心脏事件(OR,0.86,95%CI:0.75-0.99,P=0.03)、MI(OR,0.79,95%CI:0.67-0.95,P=0.01)和缺血性中风(OR,0.72,95%CI:0.58-0.89,P=0.003)的发生率较低。但心血管死亡无显著降低(OR,0.95,95%CI:0.82-1.09,P=0.45)。然而,沃拉帕沙组出血事件风险更高(P<0.001)。
本荟萃分析结果表明,在标准双联抗血小板治疗中添加沃拉帕沙可能有效降低主要不良心脏事件的发生率,但代价是出血事件风险增加。