BACKGROUND:Rivaroxaban, a direct factor Xa inhibitor, has seldom been used in patients with coronary artery disease. In this analysis, we aimed to systematically compare the efficacy and safety of rivaroxaban in addition to the anti-platelet regimen in patients with coronary artery disease. METHODS:Online databases (MEDLINE, EMBASE, Cochrane database, www.ClinicalTrials.gov and Google scholar were searched for randomized controlled trials which were exclusively based on patients with coronary artery disease; and which compared efficacy (cardiovascular outcomes) and safety (bleeding outcomes) outcomes with the addition of rivaroxaban to the other anti-platelet agents. Analysis was carried out by the RevMan 5.3 software whereby odds ratios (OR) and 95% confidence intervals (CI) were generated following data input. RESULTS:Four trials with a total number of 40,148 patients were included (23,231 participants were treated with rivaroxaban whereas 16,919 participants were treated with placebo) in this analysis. Patients' enrollment period varied from years 2006 to 2016. The current results showed addition of rivaroxaban to significantly lower composite endpoints (OR: 0.81, 95% CI: 0.74-0.88; P = 0.00001). In addition, all-cause death, cardiac death, myocardial infarction, and stent thrombosis were also significantly reduced (OR: 0.82, 95% CI: 0.72-0.92; P = 0.0009), (OR: 0.80, 95% CI: 0.69-0.92; P = 0.002), (OR: 0.87, 95% CI: 0.77-0.98; P = 0.03) and (OR: 0.73, 95% CI: 0.55-0.97; P = 0.03) respectively. However, stroke was not significantly different. However, TIMI defined minor and major bleeding were significantly higher with rivaroxaban (OR: 2.27, 95% CI: 1.47-3.49; P = 0.0002) and (OR: 3.44, 95% CI: 1.13-10.52; P = 0.03) respectively. In addition, intracranial hemorrhage and bleeding which was defined according to the International Society on Thrombosis and Hemostasis criteria were also significantly higher with rivaroxaban (OR: 1.63, 95% CI: 1.04-2.56; P = 0.03) and (OR: 1.80, 95% CI: 1.45-2.22; P = 0.00001) respectively. Nevertheless, fatal bleeding was not significantly different. CONCLUSIONS:Addition of rivaroxaban to the anti-platelet regimen was effective in patients with coronary artery disease, but the safety outcomes were doubtful. Further future trials will be able to completely solve this issue.

译文

背景:Rivaroxaban是一种直接的Xa抑制剂,很少用于冠心病患者。在这项分析中,我们旨在系统比较利伐沙班和抗血小板方案对冠心病患者的疗效和安全性。
方法:搜索在线数据库(MEDLINE,EMBASE,Cochrane数据库,www.ClinicalTrials.gov和Google Scholar),以仅基于冠心病患者的随机对照试验进行比较,并比较疗效(心血管结局)和安全性(出血结局)通过在其他抗血小板药物中添加利伐沙班来获得结果。RevMan 5.3软件进行了分析,输入数据后得出了比值比(OR)和95%置信区间(CI)。
结果:本研究共纳入四项试验,共40,148例患者(23,231名参与者接受了利伐沙班治疗,而16,919名参与者接受了安慰剂治疗)。患者的入组时间从2006年到2016年不等。当前结果显示,加入利伐沙班可显着降低复合终点(OR:0.81,95%CI:0.74-0.88; P = 0.00001)。此外,全因死亡,心源性死亡,心肌梗塞和支架内血栓形成也显着降低(OR:0.82,95%CI:0.72-0.92; P = 0.0009),(OR:0.80,95%CI:0.69- 0.92; P = 0.002),(OR:0.87,95%CI:0.77-0.98; P = 0.03)和(OR:0.73,95%CI:0.55-0.97; P = 0.03)。但是,中风并没有显着差异。但是,TIMI定义的利伐沙班的轻微和主要出血明显更高(OR:2.27,95%CI:1.47-3.49; P = 0.0002)和(OR:3.44,95%CI:1.13-10.52; P = 0.03)。此外,使用利伐沙班治疗时,根据国际血栓形成和止血标准定义的颅内出血和出血也明显更高(OR:1.63,95%CI:1.04-2.56; P = 0.03)和(OR:1.80,95 %CI:1.45-2.22; P = 0.00001)。然而,致命出血并没有显着差异。
结论:在抗血小板方案中加用利伐沙班对冠心病患者有效,但安全性结果值得怀疑。将来的进一步试验将能够完全解决该问题。

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