沙班类抗凝药与华法林比较治疗心房颤动合并冠心病患者PCI术后有效性和安全性的meta分析

Meta-analysis on efficacy and safety of salban anticoagulants versus warfarin after PCI in patients with atrial fibrillation complicating coronary heart disease

目的探讨基于沙班类药物的抗栓方案与基于华法林的抗栓方案在心房颤动合并冠心病(CHD)患者经皮冠状动脉介入治疗(PCI)术后的有效性和安全性。方法计算机检索2010年10月至2020年10月收录于PubMed、Cochrane、万方数据、中国知网(CNKI)等数据库的文献,收集沙班类药物与华法林比较治疗心房颤动合并CHD患者PCI术后的临床随机对照试验。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan5.3软件对患者的全因死亡率、国际血栓与止血协会(ISTH)大出血、临床相关非大出血(CRNMB)、卒中、心肌梗死及支架内血栓发生率进行meta分析。结果共纳入3项研究,包括8244例患者。meta分析结果显示,基于沙班类抗凝药与基于华法林的抗栓方案比较,沙班类药物组的ISTH大出血[OR=0.68,95%CI(0.55,0.84),P=0.004],CRNMB[OR=0.73,95%CI(0.64,0.84),P<0.001]发生率明显低于华法林组,两组全因死亡率、卒中、心肌梗死及支架内血栓发生率的差异均无统计学意义(P>0.05)。结论基于沙班类抗凝药抗栓方案的出血发生率低于基于华法林的抗栓方案,而缺血事件两组发生率无明显差异。

Objective To explore the efficacy and safety of salban-based antithrombotic regimen and warfarin-based antithrombotic regimen after percutaneous coronary intervention(PCI)in patients with atrial fibrillation complicating coronary heart disease(CHD).Methods The literatures were retrieved by computer from the PubMed,Cochrane Library,Wanfang Data,CNKI and other databases for collecting the randomized controlled trials(RCTs)on the salban anticoagulants vs.warfarin for the treatment after PCI in patients with atrial fibrillation complicating CHD from October 2010 to October 2020.Two researchers independently screened the literatures,extracted data and assessed the risk of bias of included studies.The meta analysis on the all-cause mortality,incidences of International Society for Thrombosis and Hemostasis(ISTH)major bleeding,clinical related non-major bleeding(CRNMB),stroke,myocardial infarction and stent thrombosis were performed by using RevMan5.3 software.Results A total of 3 RCTs involving 8244 patients were included.The meta-analysis results showed that the salban-based antithrombotic regimen vs.warfarin-based antithrombotic regimen,the incidence rate of ISTH[OR=0.68,95%CI(0.55,0.84),P=0.004],incidence rate of CRNMB[OR=0.73,95%CI(0.64,0.84),P<0.001]in the salban-based antithrombotic regimen group were significantly lower than those in the warfarin-based antithrombotic regimen group,while there was no statistically significant difference in the all-cause mortality and the incidence rates of stroke,myocardial infarction and stent thrombosis between the two groups(P>0.05).Conclusion The incidence rate of bleeding in the salban-based antithrombotic regimen is lower than that in the warfarin-based antithrombotic regimen,whileno significant difference is found in the incidence rate of ischemic events between the two regimens.