Louisiana State University School of Medicine, New Orleans, LA, USA.
Circulation. 2011 Jan 18;123(2):131-6. doi: 10.1161/CIRCULATIONAHA.110.977546. Epub 2011 Jan 3.
The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial compared dabigatran 110 mg BID (D110) and 150 mg BID (D150) with warfarin for stroke prevention in 18 113 patients with nonvalvular atrial fibrillation.
Cardioversion on randomized treatment was permitted. Precardioversion transesophageal echocardiography was encouraged, particularly in dabigatran-assigned patients. Data from before, during, and 30 days after cardioversion were analyzed. A total of 1983 cardioversions were performed in 1270 patients: 647, 672, and 664 in the D110, D150, and warfarin groups, respectively. For D110, D150, and warfarin, transesophageal echocardiography was performed before 25.5%, 24.1%, and 13.3% of cardioversions, of which 1.8%, 1.2%, and 1.1% were positive for left atrial thrombi. Continuous treatment with study drug for ≥3 weeks before cardioversion was lower in D110 (76.4%) and D150 (79.2%) compared with warfarin (85.5%; P<0.01 for both). Stroke and systemic embolism rates at 30 days were 0.8%, 0.3%, and 0.6% (D110 versus warfarin, P=0.71; D150 versus warfarin, P=0.40) and similar in patients with and without transesophageal echocardiography. Major bleeding rates were 1.7%, 0.6%, and 0.6% (D110 versus warfarin, P=0.06; D150 versus warfarin, P=0.99).
This study is the largest cardioversion experience to date and the first to evaluate a novel anticoagulant in this setting. The frequencies of stroke and major bleeding within 30 days of cardioversion on the 2 doses of dabigatran were low and comparable to those on warfarin with or without transesophageal echocardiography guidance. Dabigatran is a reasonable alternative to warfarin in patients requiring cardioversion.
随机评估长期抗凝治疗（RE-LY）试验比较了达比加群 110mg BID（D110）和 150mg BID（D150）与华法林在 18113 例非瓣膜性心房颤动患者中的卒中预防作用。
允许在随机治疗期间进行电复律。鼓励进行电复律前经食管超声心动图检查，尤其是在达比加群治疗组的患者中。分析了电复律前、电复律期间和电复律后 30 天的数据。共进行了 1983 次电复律，其中 1270 例患者分别接受了 647、672 和 664 次电复律：D110、D150 和华法林组。对于 D110、D150 和华法林，在 25.5%、24.1%和 13.3%的电复律前进行了经食管超声心动图检查，其中 1.8%、1.2%和 1.1%的患者存在左心房血栓。在电复律前连续使用研究药物≥3 周的比例在 D110（76.4%）和 D150（79.2%）中低于华法林（85.5%；两者均<0.01）。30 天内的卒中及全身性栓塞发生率分别为 0.8%、0.3%和 0.6%（D110 与华法林比较，P=0.71；D150 与华法林比较，P=0.40），且无论是否进行经食管超声心动图检查，该结果相似。大出血发生率分别为 1.7%、0.6%和 0.6%（D110 与华法林比较，P=0.06；D150 与华法林比较，P=0.99）。
这是迄今为止最大的电复律经验研究，也是首个评估该新型抗凝剂在该环境中的应用。在电复律后 30 天内，达比加群两种剂量的卒中及大出血发生率低，与华法林比较，无论是否进行经食管超声心动图检查，结果相似。在需要电复律的患者中，达比加群是华法林的合理替代选择。
