Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton,
Circulation. 2013 Jul 16;128(3):237-43. doi: 10.1161/CIRCULATIONAHA.112.001139. Epub 2013 Jun 14.
During follow-up of between 1 and 3 years in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, 2 doses of dabigatran etexilate were shown to be effective and safe for the prevention of stroke or systemic embolism in patients with atrial fibrillation. There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses.
Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit. Enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY, for up to 28 months of follow up after RE-LY (median follow-up, 2.3 years). There were 5851 patients enrolled, representing 48% of patients originally randomly assigned to receive dabigatran in RE-LY and 86% of RELY-ABLE-eligible patients. Rates of stroke or systemic embolism were 1.46% and 1.60%/y on dabigatran 150 and 110 mg twice daily, respectively (hazard ratio, 0.91; 95% confidence interval, 0.69-1.20). Rates of major hemorrhage were 3.74% and 2.99%/y on dabigatran 150 and 110 mg (hazard ratio, 1.26; 95% confidence interval, 1.04-1.53). Rates of death were 3.02% and 3.10%/y (hazard ratio, 0.97; 95% confidence interval, 0.80-1.19). Rates of hemorrhagic stroke were 0.13% and 0.14%/y.
During 2.3 years of continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily in comparison with 110 mg, and similar rates of stroke and death.
在随机评估长期抗凝治疗（RE-LY）试验的 1 至 3 年随访期间，达比加群酯的 2 种剂量被证明对预防房颤患者的中风或全身性栓塞是有效且安全的。需要对达比加群的患者进行更长时间的随访，并需要进一步的数据来比较 2 种达比加群剂量。
如果在 RE-LY 的最后一次研究访视时未永久停用研究药物，RE-LY 中的随机分配至达比加群的患者有资格参加房颤患者长期多中心达比加群治疗扩展试验（RELY-ABLE）。入组患者继续接受 RE-LY 中接受的双盲达比加群剂量，最长随访 28 个月（中位随访时间 2.3 年）。共纳入 5851 例患者，占最初随机分配至接受 RE-LY 中达比加群治疗的患者的 48%和 RELY-ABLE 合格患者的 86%。达比加群 150mg 每日 2 次和 110mg 每日 2 次的中风或全身性栓塞发生率分别为 1.46%和 1.60%/年（风险比，0.91；95%置信区间，0.69-1.20）。达比加群 150mg 每日 2 次和 110mg 每日 2 次的大出血发生率分别为 3.74%和 2.99%/年（风险比，1.26；95%置信区间，1.04-1.53）。死亡率分别为 3.02%和 3.10%/年（风险比，0.97；95%置信区间，0.80-1.19）。出血性中风发生率分别为 0.13%和 0.14%/年。
在 RE-LY 后继续使用达比加群治疗 2.3 年期间，达比加群 150mg 每日 2 次的大出血发生率高于 110mg 每日 2 次，且中风和死亡率相似。
