Coagulation Unit, Hematology Center, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden (A.M., S.S.); the Department of Medicine, Soonchunhyang University Gumi's Hospital, North Kyungsang Province, South Korea (H.-G-H.); McMaster University, Population Health Research Institute, Hamilton, ON, Canada (S.J.C., J.W.E., S.Y.); Lankenau Medical Center, Thomas Jefferson Medical College, Wynnewood, PA (M.D.E.); Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden (L.W.); Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany (M.B., M.F.); Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany (M.B.); and the Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S.S.).
Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.
The aim of this study was to compare the management and prognosis of major bleeding in patients treated with dabigatran or warfarin.
Two independent investigators reviewed bleeding reports from 1034 individuals with 1121 major bleeds enrolled in 5 phase III trials comparing dabigatran with warfarin in 27 419 patients treated for 6 to 36 months. Patients with major bleeds on dabigatran (n=627 of 16 755) were older, had lower creatinine clearance, and more frequently used aspirin or non-steroid anti-inflammatory agents than those on warfarin (n=407 of 10 002). The 30-day mortality after the first major bleed tended to be lower in the dabigatran group (9.1%) than in the warfarin group (13.0%; pooled odds ratio, 0.68; 95% confidence interval, 0.46-1.01; P=0.057). After adjustment for sex, age, weight, renal function, and concomitant antithrombotic therapy, the pooled odds ratio for 30-day mortality with dabigatran versus warfarin was 0.66 (95% confidence interval, 0.44-1.00; P=0.051). Major bleeds in dabigatran patients were more frequently treated with blood transfusions (423/696, 61%) than bleeds in warfarin patients (175/425, 42%; P<0.001) but less frequently with plasma (dabigatran, 19.8%; warfarin, 30.2%; P<0.001). Patients who experienced a bleed had shorter stays in the intensive care unit if they had previously received dabigatran (mean 1.6 nights) compared with those who had received warfarin (mean 2.7 nights; P=0.01).
Patients who experienced major bleeding on dabigatran required more red cell transfusions but received less plasma, required a shorter stay in intensive care, and had a trend to lower mortality compared with those who had major bleeding on warfarin.
http://www.ClinicalTrials.gov. Unique identifiers: NCT00262600, NCT00291330, NCT00680186, NCT00329238 and NCT00558259.
本研究旨在比较达比加群和华法林治疗患者的主要出血的管理和预后。
两名独立的调查人员对 5 项 III 期临床试验中的 1034 名 1121 例大出血患者的出血报告进行了审查，这些患者来自于 27419 例接受 6 至 36 个月治疗的患者，这些患者接受达比加群或华法林治疗。达比加群组（n=16755 例中的 627 例）中年龄较大、血肌酐清除率较低、且更频繁使用阿司匹林或非甾体抗炎药的患者多于华法林组（n=10002 例中的 407 例）。达比加群组的第一个主要出血后 30 天死亡率（9.1%）低于华法林组（13.0%；合并比值比，0.68；95%置信区间，0.46-1.01；P=0.057）。调整性别、年龄、体重、肾功能和同时抗栓治疗后，达比加群与华法林相比 30 天死亡率的合并比值比为 0.66（95%置信区间，0.44-1.00；P=0.051）。达比加群组的主要出血（696/627，42%）比华法林组（425/427，42%）更频繁地接受输血治疗（P<0.001），但较少地接受血浆治疗（达比加群，19.8%；华法林，30.2%；P<0.001）。与接受华法林的患者相比（平均 2.7 晚；P=0.01），接受达比加群的患者如果先前接受过达比加群，则在 ICU 停留的时间更短（平均 1.6 晚）。
与接受华法林的患者相比，接受达比加群的患者发生主要出血需要更多的红细胞输注，但接受的血浆更少，需要在 ICU 停留的时间更短，且死亡率有下降趋势。
http://www.ClinicalTrials.gov。唯一标识符：NCT00262600、NCT00291330、NCT00680186、NCT00329238 和 NCT00558259。
