中国心房颤动患者左心耳封堵与华法林预防血栓栓塞事件的对照研究

Comparison of left atrial appendage occlusion and warfarin for the prevention of thromboembolic events in Chinese patients with atrial fibrillation

目的 研究中国心房颤动（房颤）患者行左心耳封堵（LAAO）与华法林预防血栓栓塞事件的安全性和有效性.方法 入选2014年3月到2015年8月于武汉大学人民医院心内科接受LAAO的非瓣膜性房颤患者25例（LAAO组）.术后患者使用双抗血小板（阿司匹林＋氯吡格雷）至少3个月,在第3个月时根据经食管超声心动图（TEE）检查结果调整抗栓治疗,将双抗血小板改为单抗血小板药物治疗.同期选择25例使用华法林抗凝预防血栓栓塞事件的非瓣膜性房颤患者作为对照组（华法林组）.口服华法林,将国际标准化比值（INR）控制在2.0～3.0.均于患者出院后1、3、6、12个月进行随访,观察两组在随访期间预防血栓栓塞事件的安全性和有效性.结果 ①安全性比较：LAAO组手术成功率为100％,围术期有1例发生血栓栓塞事件,无大出血、死亡、器械栓塞等并发症.随访1年内2组均无心脏压塞、器械相关的栓塞、死亡等不良事件发生.LAAO组随访1年内有3例出血事件,华法林组有10例（P＞0.05）.但LAAO组在随访3个月后无出血事件,而华法林组有6例出血事件（P＜0.05）.②有效性比较：随访1年内,LAAO组与华法林组均无血栓栓塞事件发生.结论 本研究初步提示中国房颤患者行LAAO预防血栓栓塞安全、有效,可减少3个月后出血事件.

Objective The goal of this study was to assess the safety and efficacy of left atrial appendage occlusion（LAAO） for stroke prevention in Chinese patients with nonvalvular atrial fibrillation （AF）,compared with long-term warfarin therapy.Methods We selected 25 nonvalvular AF patients who received LAAO in the department of cardiovascular medicine of Renmin Hospital of Wuhan University from March 2014 to August 2015（LAAO group）.In LAAO group,the dual antiplatiplatelet medication （aspirin plus clopidogrel） was given for at least 3 months,in the third month to change dual antiplatelet medication for single antiplatelet according to the examination result of transesophageal echocardiography（TEE）,with the ratio of 1：1 selected AF patient who receive chronic warfarin therapy as the control group （warfarin group）.In warfarin group,standard medication of warfarin was given adjusting the INR in the range between 2.0 and 3.0.After discharge,patients were followed at 1,3,6,12 months.The effectiveness and safety were evaluated.Results ①The operation success rate was 100％ for the patients who receive LAAO.During perioperative period,there was one case of thrombosis,and no complications such as bleeding,death and thrombosis on the occluder surface was observed.During 1 year of follow-up,there was no adverse events such cardiac tamponade,device related embolism,or death between two groups.During 1 year of follow-up,3 cases had the bleeding event in LAAO group,while 10 cases in the warfarin group（P＞0.05）.After 3 months,there no bleeding event in LAAO group.In the warfarin group,6 patients had bleeding event （P＜0.05）.②Follow-up for one year,there was no thromboembolic events in LAAO group and warfarin group.Conclusion Present study shows LAAO is safe and effective for the prevention of thromboembolism in Chinese patients with AF.It can reduce the incidence of bleeding events after 3 months.