非瓣膜性心房颤动射频导管消融术围术期抗凝治疗的临床特征与卫生经济学分析

Current Status and Trend of Oral Anticoagulation in Patients With Non-valvular Atrial Fibrillation Undergoing Radiofrequency Ablation in China——a Retrospective Health Economic Study of 1936 Patients

目的:探讨近5年来非瓣膜性心房颤动(房颤)射频导管消融术围术期抗凝治疗状况及卫生经济学特点,分析华法林与新型口服抗凝药物(NOAC,包括利伐沙班及达比加群酯)的有效性及安全性。方法:连续性入选2015年1月至2019年8月中国医学科学院阜外医院一病区住院的1936例非瓣膜性房颤患者,其中男性1406例(72.60%),女性530例(27.40%),平均年龄(56.4±10.4)岁。根据患者服药情况分为华法林组(n=660),利伐沙班组(n=620),达比加群酯组(n=656)。对其围术期抗凝方案、药物构成比例、治疗费用及出血、栓塞事件进行回顾性分析,随访期限为术后3个月。结果:1936例患者房颤病程中位时间为3(1,6)年。2015~2019年华法林使用比例呈明显下降(2015年vs.2019年:79.80%vs.20.24%,P<0.001),利伐沙班及达比加群酯使用比例均呈明显上升(P均<0.001);2015~2017年年化人均药物费用[元(/年·人)]呈显著上升趋势(2609.9 vs.6096.4 vs.10339.4,P<0.001);成本效果分析显示华法林较利伐沙班、达比加群酯具有更优的成本效果比(217.8 vs.13158.7 vs.12142.1,P<0.001)。3个月随访期间无死亡事件,共发生大出血9例(0.46%)及栓塞事件17例(0.88%),包括中枢神经系统栓塞15例;华法林组与利伐沙班组、达比加群酯组的栓塞发生率(1.20%vs.0.65%vs.0.76%,P=0.35)及大出血并发症发生率(0.76%vs.0.32%vs.0.30%,P=0.40)差异均无统计学意义。1936例患者中1439例患者为间断性抗凝治疗,497例连续性抗凝治疗,亚组分析显示,华法林与NOAC抗凝药使用后患者并发症发生差异均无统计学意义。结论:非瓣膜性房颤患者射频导管消融术围术期抗凝治疗中,华法林与NOAC的安全性及有效性相当;成本效果分析显示华法林较NOAC有明显的效价优势。

Objectives:This respective study analyzed the clinical characteristics and health economic data of periprocedural anticoagulation in non-valvular atrial fibrillation(NVAF)patients undergoing radiofrequency ablation in the past 5 years in our center.Methods:A total of 1936 consecutive patients(1406 male,mean age:[56.4±10.4]years)with non-valvular AF and hospitalized in Fuwai Hospital from January 2015 to August 2019 were enrolled,all patients received transcatheter radiofrequency ablation.We retrospectively analyzed the clinical application and cost of anticoagulation and the incidence of major bleeding and embolization events in the cohort to assess the safety and efficacy of different oral anticoagulants(warfarin[n=660],rivaroxaban[n=620],dabigatran[n=656]).Patients were followed-up to 3 months post radiofrequency ablation.Results:From 2015 to 2019,the proportion of warfarin use decreased significantly(2015 vs.2019:79.80%vs.20.24%,P<0.001),and the use of rivaroxaban and dabigatran increased significantly:rivaroxaban(2015 vs.2019:2.05%vs.39.06%,P<0.001),and dabigatran(2015 vs.2019:18.16%vs.40.71%,P<0.001).The cost-effectiveness analysis showed that warfarin had a better cost-effectiveness ratio than rivaroxaban and dabigatran(217.8 vs.13158.7 vs.12142.1,P<0.001).During the 3 month follow-up,no deaths occurred,and there were 9 cases(0.46%)of major hemorrhage and 17 cases(0.88%)of embolization events,including 15 cases of central nervous system embolization.The prevalence of embolization(1.20%vs.0.65%vs.0.76%,P=0.35)and complications of major bleeding(0.76%vs.0.32%vs.0.30%,P=0.40)were similar among warfarin and rivaroxaban and dabigatran groups,and there was also no significant difference between the analysis of continuous(n=497)and intermittent(n=1439)anticoagulation subgroups between warfarin and the novel oral anticoagulants(NOAC).Conclusions:The results suggest that warfarin and NOACs have similar safety and efficacy in perioperative anticoagulation therapy for patients with NVAF undergoing radiofrequency ablation.In addition,warfarin is more costeffective than NOAC from the perspective of health economics.