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房颤射频消融术后的口服抗凝治疗与血栓栓塞和严重出血的风险:丹麦全国队列的长期随访。

Oral anticoagulation therapy after radiofrequency ablation of atrial fibrillation and the risk of thromboembolism and serious bleeding: long-term follow-up in nationwide cohort of Denmark.

机构信息

Department of Cardiology, Copenhagen University Hospital Gentofte, Niels Andersens Vej 65, Hellerup 2900, Denmark

Department of Cardiology, Copenhagen University Hospital Gentofte, Niels Andersens Vej 65, Hellerup 2900, Denmark National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.

出版信息

Eur Heart J. 2015 Feb 1;36(5):307-14a. doi: 10.1093/eurheartj/ehu421. Epub 2014 Nov 3.

Abstract

AIM

To investigate the long-term risk of thromboembolism and serious bleeding associated with oral anticoagulation (OAC) therapy beyond 3 months after radiofrequency ablation (RFA) of atrial fibrillation (AF).

METHODS AND RESULTS

Linking Danish administrative registries, 4050 patients undergoing first-time RFA (2000-11) were identified. Risk of thromboembolism and serious bleeding according to OAC therapy were analysed by incidence rates (presented per 100 person-years) and Cox proportional-hazard models. The median age was 59.5 years (interquartile range, IQR: 52.8-65.2); 26.5% were females. During a median follow-up of 3.4 years (IQR: 2.0-5.6), 71 (1.8%) thromboembolism cases were identified, where incidence rates with and without OAC were 0.56 (0.40-0.78)95%CI and 0.64 (0.46-0.89)95%CI, respectively. Oral anticoagulation discontinuation remained insignificant [hazard ratio 1.42(0.86-2.35)95%CI] in multivariable analysis. Beyond 3 months after RFA 87 (2.1%) serious bleedings occurred; incidence rates with and without OAC were 0.99 (0.77-1.27)95%CI and 0.44 (0.29-0.65)95%CI, respectively. Oral anticoagulation therapy was significantly associated with serious bleeding risk [hazard ratio 2.05(1.25-3.35)95%CI]. In an age- and gender-matched cohort (1 : 4) of 15 848 non-ablated AF patients receiving rhythm-control therapy, thromboembolic rates with and without OAC were 1.34 (1.21-1.49)95%CI and 2.14 (1.98-2.30)95%CI, respectively. Adjusted incidence rate ratio was 0.53 (0.43-0.65)95%CI favouring RFA cohort.

CONCLUSION

Thromboembolic risk beyond 3 months after RFA was relatively low compared with a matched non-ablated AF cohort. With cautious interpretation due to low number of events, serious bleeding risk associated with OAC seems to outweigh the benefits of thromboembolic risk reduction. Randomized studies are warranted to test our results.

摘要

目的

研究射频消融(RFA)治疗心房颤动(AF)后 3 个月以上口服抗凝(OAC)治疗相关的血栓栓塞和严重出血的长期风险。

方法和结果

通过丹麦行政登记处进行链接,确定了 4050 名首次接受 RFA(2000-11 年)的患者。通过发病率(每 100 人年呈现)和 Cox 比例风险模型分析 OAC 治疗相关的血栓栓塞和严重出血风险。中位年龄为 59.5 岁(四分位距,IQR:52.8-65.2);26.5%为女性。在中位随访 3.4 年(IQR:2.0-5.6)期间,共发现 71 例(1.8%)血栓栓塞病例,有和无 OAC 的发生率分别为 0.56(0.40-0.78)95%CI 和 0.64(0.46-0.89)95%CI。多变量分析中,OAC 停药仍无显著意义[风险比 1.42(0.86-2.35)95%CI]。RFA 后 3 个月以上发生 87 例(2.1%)严重出血;有和无 OAC 的发生率分别为 0.99(0.77-1.27)95%CI 和 0.44(0.29-0.65)95%CI。OAC 治疗与严重出血风险显著相关[风险比 2.05(1.25-3.35)95%CI]。在一个年龄和性别匹配的 15848 名非消融 AF 患者节律控制治疗的队列(1:4)中,有和无 OAC 的血栓栓塞率分别为 1.34(1.21-1.49)95%CI 和 2.14(1.98-2.30)95%CI。调整后的发病率比为 0.53(0.43-0.65)95%CI,有利于 RFA 队列。

结论

与匹配的非消融 AF 队列相比,RFA 后 3 个月以上的血栓栓塞风险相对较低。由于事件数量较少,谨慎解释后,OAC 相关的严重出血风险似乎超过了血栓栓塞风险降低的益处。需要进行随机研究来检验我们的结果。

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