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ODIn-AF试验的原理与设计:房颤肺静脉隔离术后使用达比加群口服抗凝预防无症状性脑栓塞的随机评估

Rationale and design of the ODIn-AF Trial: randomized evaluation of the prevention of silent cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation.

作者信息

Schrickel Jan W, Linhart Markus, Bänsch Dietmar, Thomas Daniel, Nickenig Georg

机构信息

Department of Medicine-Cardiology, University Hospital Bonn, Bonn, Germany.

Department of Cardiology, Rhythmology, University Hospital Rostock, Rostock, Germany.

出版信息

Clin Res Cardiol. 2016 Feb;105(2):95-105. doi: 10.1007/s00392-015-0933-1. Epub 2015 Oct 29.

DOI:10.1007/s00392-015-0933-1
PMID:26514352
Abstract

Oral anticoagulation treatment following clinically successful catheter ablation of atrial fibrillation is controversial. Recent guidelines recommend continuation of oral anticoagulation in all patients with CHA2DS2VASc score ≥ 2 even if there is no evidence of recurrent atrial fibrillation. Due to lack of prospective data, the net clinical benefit of oral anticoagulation after successful ablation in these patients is unclear. As oral anticoagulation bears the risk of severe bleeding events, the ODIn-AF study aims to evaluate the effect of oral anticoagulation on the incidence of silent cerebral embolic events in patients with a high risk for embolic events, but free from symptomatic atrial fibrillation after successful pulmonary vein ablation.

摘要

房颤导管消融临床成功后口服抗凝治疗存在争议。近期指南建议,所有CHA2DS2VASc评分≥2的患者即使没有房颤复发证据也应继续口服抗凝治疗。由于缺乏前瞻性数据,这些患者消融成功后口服抗凝治疗的净临床获益尚不清楚。鉴于口服抗凝治疗存在严重出血事件风险,ODIn-AF研究旨在评估口服抗凝治疗对肺静脉消融成功后有栓塞事件高风险但无症状性房颤患者无症状脑栓塞事件发生率的影响。

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Recommendations for the emergency management of complications associated with the new direct oral anticoagulants (DOACs), apixaban, dabigatran and rivaroxaban.新型直接口服抗凝剂(DOACs),即阿哌沙班、达比加群和利伐沙班相关并发症的紧急处理建议。
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Venice Chart international consensus document on atrial fibrillation ablation: 2011 update.《威尼斯房颤消融国际共识文件:2011年更新版》
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2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society.2012年心房颤动导管消融与外科消融专家共识声明:患者选择、手术技术、患者管理与随访、定义、终点及研究试验设计的建议:心律学会(HRS)心房颤动导管消融与外科消融特别工作组报告。与欧洲心脏病学会(ESC)注册分支欧洲心律协会(EHRA)及欧洲心脏心律失常学会(ECAS)合作制定;并与美国心脏病学会(ACC)、美国心脏协会(AHA)、亚太心律学会(APHRS)和胸外科医师学会(STS)协作。得到美国心脏病学会基金会、美国心脏协会、欧洲心脏心律失常学会、欧洲心律协会、胸外科医师学会、亚太心律学会和心律学会管理机构的认可。
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