达比加群酯用于心房颤动导管消融伴电复律患者抗凝治疗有效性及安全性研究

Effectiveness and safety of anticoagulation therapy with dabigatran etexilate in patients undergoing catheter ablation and cardioversion procedures for atrial fibrillation

目的 评估达比加群酯用于心房颤动（房颤）导管消融伴电复律围术期抗凝治疗的有效性及安全性.方法 选择从2012年1月至2014年10月于沈阳军区总医院接受房颤导管消融及直流电复律的患者.将符合入组条件的患者分为达比加群酯组（n=60例）和华法林组（n=36例）.所有患者术前经食管超声心动图检查证实无左心房血栓.达比加群酯组：围术期110 mg或150 mg,2次/d口服,最少服用至术后2个月.华法林组：围术期根据国际标准化比值（INR）调整剂量,控制INR在2.0～3.0,最少服用至术后2个月.所有患者抗凝自开始至结束均不调整抗凝药.结果 ①基线资料：两组患者的性别、年龄、体质指数、房颤类型、复律次数、CHADS2评分、HAS-BLED评分及肾功能指标差异均无统计学意义（P〉0.05）.②安全性及有效性：华法林组和达比加群酯组患者的血栓栓塞事件发生率差异无统计学意义（分别为0/36例和0/60例,P〉0.05）.两组均无大出血事件发生;不明显出血事件达比加群酯组为2/60例、华法林组2/36例,差异无统计学意义（P〉0.05）.华法林组的总住院天数、术前和术后住院天数较达比加群酯组明显延长（均P〈0.05）.结论 与华法林相比,口服达比加群酯用于血栓栓塞低、中危房颤患者导管消融及电复律围术期抗凝安全有效,可明显缩短总住院时间,导管消融和电复律术前和术后住院时间.

Objective To evaluate effectiveness and safety of anticoagulation therapy with dabigatran etexilate in patients with atrial fibrillation（AF）undergoing catheter ablation and direct current cardioversion（CV）.Methods A cohort of 96 patients who underwent catheter ablation and CV of AF was enrolled.The 96 patients were divided into two groups,60 patients in dabigatran group and 36 in warfarin group.In dabigatran group,dabigatran（110 mg or 150 mg,bid）had been given for at least 2 month.In warfarin group,international normalized ratio（INR）was adjusted in the range between 2.0 and 3.0 during standard medication of warfarin.None of the patients changed anticoagulant during the anticoagulation therapy.Results ①There were no differences in baseline characteristics between two groups.②There were no differences between 2 groups on the death and thromboembolism events,including cerebral,systemic and pulmonary emboli（no patient in either dabigatran group or in warfarin group,P〉0.05）.There were no major bleeding events in either group.There were no significant differences in minor bleeding events between dabigatran group and warfarin group（2/60 vs.2/36,P〉0.05）.③The length of hospital stay（including total,pre-ablation and post-ablation hospital stay）was significantly shorter in dabigatran group than in warfarin group.Conclusion Compared with oral warfarin,the effectiveness and safety of oral dabigatran have no inferior effect in the patients undergoing catheter ablation and CV of AF.Application of dabigatran is safe and effective in the AF patients with low or middle risk of thromboembolism,and could significantly decrease the length of hospital stay.