达比加群酯在房性快速心律失常射频导管消融围术期抗凝治疗中的应用

Safety and efficacy of dabigatran for the peri-procedural anticoagulation in patients undergoing abla- tion of atrial tachyarrhythmias

目的比较达比加群酯和华法林在房性快速心律失常（ATA）射频导管消融（RFCA）围术期抗凝的安全性及有效性。方法2013年9月至2015年4月在南京医科大学第一附属医院行RFCA的A1IA患者共859例，其中165例服用达比加群酯（达比加群酯组），根据年龄、性别、ATA类型和基础疾病等匹配出165例患者服用华法林（华法林组）。调查两组患者围术期的抗凝方案，比较栓塞、出血和其他不良事件的发生率。结果达比加群酯组术中激活的活化凝血时间（ACT）基础值[（143．6±24．9）s对（197．8±59．9）s]、达标值[（281．1±26．7）s对（311．4±40．8）s]、峰值[（290．1±31．3）S对（325．3＋39．1）s]均显著低于华法林组（P〈0．001），术中所需肝素总量显著高于华法林组[（8979．0±3241．2）U对（5592．0±3251．1）U]（P〈0．001）。两组均未出现栓塞事件，华法林组发生严重出血2例，轻微出血26例；达比加群酯组出现严重出血2例，轻微出血17例，差异无统计学意义（P〉0．05）。达比加群酯组胃肠道反应发生率高于华法林组（9．1％对0，P〈0．001）。结论达比加群酯可安全有效地用于ATA患者RFCA围术期的抗凝，术中应加强ACT监测。

Objective To evaluate the safety and efficacy of dabigatran for the peri-procedural antico- agulation in patients with atrial tachyarrhythmias （ATA）undergoing radiofrequency catheter ablation （RFCA）. Methods From September 2013 to April 2015,859 patients who underwent RFCA of ATA in the First Affilia- ted Hospital of Nanjing Medical University were retrospectively reviewed. Among them, 165 patients administra- ted with dabigatran were defined as Dabigatran group, and another 165 patients taking warfarin matched with age （±3years）, sex, type of ATA, and comorbidities were defined as Warfarin group. We evaluated detailed peri- procedural anticoagulation regimens, and compared the incidence of thromboembolic events, major and minor bleeding events and other adverse effects of drugs between these two groups. Results Compared to Warfarin group,Dabigatran group had significantly lower level of the baseline activated clotting time （ACT） [ （ 143.6± 24. 9）s vs（ 197. 8±59. 9）s,P〈0. 001 ] ,target ACT for the first time[ （281.1±26. 7）s vs（ 311.4±40. 8）s,P〈 0. 001 ] ,peak value of ACT[ （290. 1±31.3）s vs（325.3±39. 1） s,P〈0. 001] （P〈0. 001）. However,the hepa- fin dose throughout procedure was signifieantly higher in Dabigatran group[ （8979.0±3241.2）U vs（ 5592. 0± 3251.1 ）U,P〈0. 001 ]. There was no thrombembolie event in both groups. Totally, 28 （17%, 2 major）and 19 （11.5% ,2 major）hemorrhagic eomplieations oceurred in Warfarin and Dabigatran groups, respectively. The to- tal incidence of thromboembolie and hemorrhagic eomplieations were similar in both groups（P〉0.05）. The in- eidenee of gastrointestinal adverse events was significantly higher in Dabigatran group compared with Warfarin group （9. 1% vs. 0, P〈0. 001 ）. Conclusion This study demonstrated that dabigatran had similar safety and efficacy compared with warfarin for the peri-procedural anticoagulation in patients undergoing RFCA of ATA, and carefully monitoring the ACT during the procedure should be emphasized to titrate appropriate heparin dose.