达比加群或华法林治疗急性静脉血栓栓塞症及汇总分析。
Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
机构信息
Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, C.K.); Department of Hematology, Karolinska University Hospital, Stockholm, Sweden (S.S.); Thrombosis Research Institute and University College London, London, UK (A.K.K.); Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.Z.G.); Medical Division 2, Municipal Hospital Friedrichstadt, Dresden, Germany (S. Schellong); Department of Medicine, Sahlgrenska University Hospital-Östra, Gothenburg, Sweden (H.E.); Department of Vascular Pathology, Bellevue Hospital, Saint Etienne, France (P.M.); Clinical Research, Boehringer Ingelheim, Copenhagen, Denmark (A.V.C.); Boehringer Ingelheim, Ridgefield, CT (J.F.); Boehringer Ingelheim, Reims, France (F.L.M.); and Boehringer Ingelheim, Biberach and der Riss, BDM, Germany (N.P.).
出版信息
Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.
BACKGROUND
Dabigatran and warfarin have been compared for the treatment of acute venous thromboembolism (VTE) in a previous trial. We undertook this study to extend those findings.
METHODS AND RESULTS
In a randomized, double-blind, double-dummy trial of 2589 patients with acute VTE treated with low-molecular-weight or unfractionated heparin for 5 to 11 days, we compared dabigatran 150 mg twice daily with warfarin. The primary outcome, recurrent symptomatic, objectively confirmed VTE and related deaths during 6 months of treatment occurred in 30 of the 1279 dabigatran patients (2.3%) compared with 28 of the 1289 warfarin patients (2.2%; hazard ratio, 1.08; 95% confidence interval [CI], 0.64-1.80; absolute risk difference, 0.2%; 95% CI, -1.0 to 1.3; P<0.001 for the prespecified noninferiority margin for both criteria). The safety end point, major bleeding, occurred in 15 patients receiving dabigatran (1.2%) and in 22 receiving warfarin (1.7%; hazard ratio, 0.69; 95% CI, 0.36-1.32). Any bleeding occurred in 200 dabigatran (15.6%) and 285 warfarin (22.1%; hazard ratio, 0.67; 95% CI, 0.56-0.81) patients. Deaths, adverse events, and acute coronary syndromes were similar in both groups. Pooled analysis of this study RE-COVER II and the RE-COVER trial gave hazard ratios for recurrent VTE of 1.09 (95% CI, 0.76-1.57), for major bleeding of 0.73 (95% CI, 0.48-1.11), and for any bleeding of 0.70 (95% CI, 0.61-0.79).
CONCLUSION
Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE.
CLINICAL TRIAL REGISTRATION URL
www.clinicaltrials.gov. Unique identifiers: NCT00680186 and NCT00291330.
背景
达比加群酯和华法林曾在一项先前的试验中被用于治疗急性静脉血栓栓塞症（VTE）。我们进行这项研究旨在扩展这些发现。
方法和结果
在一项纳入了 2589 例接受低分子肝素或未分级肝素治疗 5 至 11 天的急性 VTE 患者的随机、双盲、双模拟试验中，我们比较了达比加群酯 150mg 每日 2 次与华法林的疗效。主要终点为治疗 6 个月期间复发的有症状、经客观证实的 VTE 及相关死亡，在 1279 例达比加群酯治疗患者中发生了 30 例（2.3%），而在 1289 例华法林治疗患者中发生了 28 例（2.2%）（风险比，1.08；95%置信区间[CI]，0.64-1.80；绝对风险差异，0.2%；95%CI，-1.0 至 1.3；对于两个标准的预设非劣效性边界，P<0.001）。主要出血事件的安全性终点在接受达比加群酯治疗的 15 例患者（1.2%）和接受华法林治疗的 22 例患者（1.7%）中发生（风险比，0.69；95%CI，0.36-1.32）。任何出血事件在 200 例接受达比加群酯治疗的患者（15.6%）和 285 例接受华法林治疗的患者（22.1%）中发生（风险比，0.67；95%CI，0.56-0.81）。两组的死亡、不良事件和急性冠状动脉综合征均相似。该研究 RE-COVER II 与 RE-COVER 试验的汇总分析得出的 VTE 复发风险比为 1.09（95%CI，0.76-1.57），大出血风险比为 0.73（95%CI，0.48-1.11），任何出血风险比为 0.70（95%CI，0.61-0.79）。
结论
与华法林相比，达比加群酯在治疗急性 VTE 时具有相似的 VTE 复发效果，且出血风险更低。
临床试验注册网址
www.clinicaltrials.gov。唯一标识符：NCT00680186 和 NCT00291330。
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