新型口服抗凝剂与维生素K拮抗剂对经导管主动脉瓣置换术合并长期抗凝指征患者预后影响比较的Meta分析

Comparison of impact on prognosis between new oral anticoagulants and Vitamin K antagonists in patients with long-term anticoagulation indications after transcatheter aortic valve replacement: a Meta-analysis

目的 比较新型口服抗凝剂(NOACs)和维生素K拮抗剂(VKAs)对接受经导管主动脉瓣置换术(TAVR)且合并长期抗凝指征患者预后的影响。方法 系统检索EMbase、MedLine和Cochrane数据库,检索时间范围为建库至2021年9月,收集比较NOACs和VKAs对接受经导管主动脉瓣置换术(TAVR)且合并长期抗凝指征患者预后影响的研究,由两位研究者独立筛选所有符合纳入标准的研究并提取资料,主要预后指标包括术后30 d、6个月、1年及1年以上的全因死亡率、卒中发生率、大出血或危及生命的出血(LT/MB)发生率。Meta分析使用STATA 12.0软件进行分析,并使用漏斗图评价发表偏倚风险。结果 最终纳入符合标准的文献有6篇,全部为队列研究,共有2358例患者。结果显示,对TAVR合并长期抗凝指征患者,NOACs组与VKAs组相比,在30 d(RR=1.20,95%CI:0.55~2.64)、6~12个月(RR=1.06,95%CI:0.86~1.31)、2年(RR=1.11,95%CI:0.94~1.30)及总体(RR=1.09,95%CI:0.95~1.24)全因死亡率方面无明显差异(P均>0.05);在30 d、6~12个月、2年及总体LT/MB发生率及卒中发生率方面无明显差异(P均>0.05)。结论 对于接受TAVR手术合并长期抗凝指征的患者,与使用VKAs相比,使用NOACs抗凝治疗不会增加全因死亡率、LT/MB及卒中发生率。

Objective To compare the influence on prognosis between new oral anticoagulants(NOAC) and Vitamin K antagonists(VKA) in patients with long-term anticoagulation indications after transcatheter aortic valve replacement(TAVR). Methods The databases of EMbase, MedLine and Cochrane were systematically retrieved from database establishment time to Sept. 2021. The studies on the influence of NOAC and VKA on prognosis in patients with long-term anticoagulation indications after TAVR were collected and compared. The eligible studies were screened and data was extracted by 2 researchers independently. The main prognosis indexes included allcause mortality and incidence rates of stroke and life-threatening/major bleeding(LT/MB) after the operation for 30 d,6 months and 1 y and more than 1 y. STATA 12.0 software was used in the Meta-analysis, and funnel plot was used to review the risk of publication bias. Results There were totally 6 eligible studies included, which were all cohort studies involved 2358 patients. The results of Meta-analysis showed that, between NOAC group and VKA group, the differences in 30 d all-cause mortality(RR=1.20, 95%CI: 0.55~2.64), 6-12 month all-cause mortality(RR=1.06, 95%CI: 0.86~1.31), 2 y all-cause mortality(RR=1.11, 95%CI: 0.94~1.30) and the total all-cause mortality(RR=1.09, 95%CI: 0.95~1.24) were not significant(all P>0.05), and the differences in 30 d, 6-12 month,2 y and the totally LT/MB incidence rates and stroke incidence rates were not significant(all P>0.05). Conclusion NOAC cannot promote all-cause mortality and incidence rates of LT/MB and stroke compared with VKA in patients undergone TAVR with long-term anticoagulation indications.