新型口服抗凝药用于冠心病合并心房颤动PCI患者疗效及安全性的Meta分析

Curative effect and safety of new oral anticoagulants in patients with coronary heart disease complicated by atrial fibrillation after PCI: a Meta-analysis

目的对新型口服抗凝药(NOAC)用于冠状动脉粥样硬化性心脏病(冠心病)合并心房颤动(房颤)行经皮冠状动脉(冠脉)支架植入术(PCI)患者的疗效及安全性进行Meta分析,了解NOAC在疗效及安全性方面是否优于华法林。方法通过检索PubMed、EMbase、Cochrane等数据库中发表的NOAC相比于华法林对冠心病合并房颤PCI患者疗效及安全性的相关研究,采用软件RevMan 5.2进行Meta分析。结果最终纳入6篇研究,纳入病例5723例,其中实验组3553例,对照组2170例。对纳入文献进行Meta分析结果显示,实验组与对照组之间在支架内血栓形成风险、再发心肌梗死风险、卒中风险、死亡风险方面,差异均无统计学意义(OR=1.39,95%CI:0.80～2.41,P=0.24,I2=0;OR=1.07,95%CI:0.78～1.46,P=0.69,I2=28.1;OR=1.11,95%CI:0.70～1.76,P=0.66,I2=0;OR=1.02,95%CI:0.76～1.36,P=0.91,I2=0);在主要出血风险方面差异有统计学意义(OR=0.57,95%CI:0.45～0.71,P<0.00001,I2=0%)。结论冠心病合并房颤PCI患者在联合抗凝、抗血小板治疗中,NOAC相比于华法林而言可明显降低主要出血风险,同时不增加支架内血栓形成、再发心肌梗死、卒中、死亡的风险;由此可见,新型口服抗凝药物在临床疗效方面并不亚于华法林,且在安全性方面有明显优势。

Objective To conduct a Meta-analysis on the curative effect and safety of new oral anticoagulants(NOAC)in patients with coronary heart disease(CHD)complicated by atrial fibrillation(AF)after PCI,and to discuss the difference in curative effect and safety between NOAC and warfarin.Methods The related studies on curative effect and safety of NOAC compared with warfarin in patients with CHD complicated by AF were retrieved from databases of PubMed,EMbase and Cochrane,and then given a Meta-analysis by applying RevMan 5.2 software.Results There were totally 6 studies chosen involving 5723 cases,and 3553 in test group and 2170 in control group.The results of Meta-analysis showed that the difference in risks of in-stent thrombosis(OR=1.39,95%CI:0.80~2.41,P=0.24,I^2=0),recurrence of myocardial infarction(OR=1.07,95%CI:0.78~1.46,P=0.69,I^2=28.1),stroke(OR=1.11,95%CI:0.70~1.76,P=0.66,I 2=0)and death(OR=1.02,95%CI:0.76~1.36,P=0.91,I^2=0)had no statistical significance between test group and control group.The difference in major bleeding risks had statistical significance between 2 groups(OR=0.57,95%CI:0.45~0.71,P<0.00001,I^2=0).Conclusion NOAC,compared with warfarin,can reduce major bleeding risk and does not increase the risks of in-stent thrombosis,recurrence of myocardial infarction,stoke and death at the same time in combined anticoagulation and antiplatelet treatment in patients with CHD complicated by AF.NOAC is as good as warfarin in clinical efficacy and has obvious advantages in safety compared with warfaring.