摘要
目的评估新型口服抗凝剂在接受第二代冷冻球囊消融术的老年心房颤动(房颤)患者中的有效性和安全性。方法选取2016年8月至2018年6月中国医学科学院阜外医院收治的接受冷冻球囊消融术的老年房颤患者101例,根据口服抗凝药物的种类将其分为利伐沙班组(42例)和达比加群酯组(59例),比较两组患者用药的安全性和有效性。结果术中及术后3个月内,共12例(11.9%)患者发生出血事件。两组患者发生主要出血事件的风险比为1.4(95%CI:0.28~7.5,P=0.691),发生次要出血事件的风险比为2.79(95%CI:0.52~17.21,P=0.230);两组患者发生血栓栓塞事件的风险比为0.7(95%CI:0.06~7.93,P=1.000)。共有11例(91.67%)出血事件发生在消融术后48 h内,而1例(8.33%)发生在消融术至少7 d后。结论在接受第二代冷冻球囊消融术的老年房颤患者抗凝治疗中,利伐沙班与达比加群酯的抗凝效果相当,且安全性均较高。
Objective To evaluate the efficacy and safety of novel oral anticoagulants in elderly patients with atrial fibrillation undergoing second-generation cryoballoon ablation. Method A total of 101 elderly patients with atrial fibrillation admitted to our hospital from August 2016 to June 2018 were selected, they were divided into Rivaroxaban group(42 cases) and Dabigatran group(59 cases) according to the types of oral anticoagulants. The safety and efficacy of the two groups of patients were compared. Result A total of 12 patients(11.9%) had bleeding events during and 3 months after surgery. The risk ratio of major bleeding events between the two groups was 1.4(95%CI: 0.28 ~ 7.5, P = 0.691), and the risk ratio of minor bleeding events was 3.0(95%CI: 0.52 ~ 17.21,P = 0.230). The risk ratio of thromboembolic events between the two groups was 0.7(95%CI: 0.06 ~ 7.93, P = 1.000). A total of11(91.67%) bleeding events occurred within 48 hours after ablation, while 1(8.33%) occurred after at least 7 days. Conclusion Rivaroxaban and Dabigatran showed similar anticoagulation effect and higher safety in elderly patients with atrial fibrillation who received second-generation cryoablation.
引文
[1]Heeger CH,Tscholl V,Wissner E,et al.Acute efficacy,safety,and long-term clinical outcomes using the second-generation cryoballoon for pulmonary vein isolation in patients with a left common pulmonary vein:A multicenter study[J].Heart Rhythm,2017,14(8):1111-1118.
[2]Kuck KH,Brugada J,Fürnkranz A,et al.Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation[J].N Engl J Med,2016,374(23):2235-2245.
[3]刘俊,李劲宏,方丕华.第二代冷冻球囊消融治疗心房颤动的应用进展[J].中国心脏起搏与心电生理杂志,2015,29(1):61-63.
[4]January CT,Wann LS,Alpert JS,et al.2014 AHA/ACC/HRSguideline for the management of patients with atrial fibrillation:executive summary:a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society[J].Circulation,2014,130(23):2071-2104.
[5]Kirchhof P,Benussi S,Kotecha D,et al.2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS[J].Europace,2016,18(11):1609-1678.
[6]吴书林,薛玉梅,黄俊.心房颤动导管消融围术期抗凝治疗进展[J].中国医学前沿杂志(电子版),2012,4(12):8-12.
[7]方丕华.心房颤动卒中高危患者围导管消融术的抗凝治疗[J].中国医学前沿杂志(电子版),2008,1(1):20-23.
[8]邸成业,万征,林文华.利伐沙班用于心房颤动冷冻消融术中抗凝治疗的安全性和有效性观察[J].中华医学杂志,2017,97(33):2591-2594.
[9]韩延辉,王红雷,来利红,等.心房颤动患者血栓形成的影响因素分析[J].中国医学前沿杂志(电子版),2016,8(10):78-82.
[10]Maddox W,Kay GN,Yamada T,et al.Dabigatran versus warfarin therapy for uninterrupted oral anticoagulation during atrial fibrillation ablation[J].J Cardiovasc Electrophysiol,2013,24(8):861-865.
[11]Calkins H,Willems S,Gerstenfeld EP,et al.Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation[J].N Engl J Med,2017,377(5):494-495.
[12]Di Biase L,Burkhardt JD,Santangeli P,et al.Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagul ation management:results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation(AF)Patients Undergoing Catheter Ablation(COMPARE)rando mized trial[J].Circulation,2014,129(25):2638-2644.
[13]陈诤,李晓宏,蓝荣芳,等.心房颤动患者导管消融围术期应用口服抗凝药安全性观察[J].中华心律失常学杂志,2017,21(4):280-284.
[14]Yokokawa M,Chugh A,Latchamsetty R,et al.Cryoballoon antral pulmonary vein isolation vs contact force-sensing radiofrequency catheter ablation for pulmonary vein and posterior left atrial isolation in patients with persistent atrial fibrillation[J].Heart Rhythm,2018,15(12):1835-1841.
[15]Boveda S,Metzner A,Nguyen D Q,et al.Single-Procedure Outcomes and Quality-of-Life Improvement 12 Months PostCryoballoon Ablation in Persistent Atrial Fibrillation:Results From the Multicenter CRYO4PERSISTENT AF Trial[J].JACCClin Electrophysiol,2018,4(11):1440-1447.
[16]Calkins H,Hindricks G,Cappato R,et al.2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation[J].Heart Rhythm,2017,14(10):e275-e444.
[17]王紫晨,华琦,李耘,等.CHADS2评分及CHA2DS2-VASc评分预测老年非瓣膜性心房颤动合并缺血性脑卒中患者短期预后的意义[J].中国心血管杂志,2015,20(5):334-338.
[18]Gallego P,Roldán V,Torregrosa JM,et al.Relation of the HAS-BLED bleeding risk score to major bleeding,cardiovascular events and mortality in anticoagulated patients with atrial fibrillation[J].Circ Arrhythm Electrophysiol,2012,5(2):312-318.
[19]Vinogradova Y,Coupland C,Hill T,et al.Risks and benefits of direct oral anticoagulants versus warfarin in a real world setting:cohort study in primary care[J].BMJ,2018,362:k2505.