Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Medicine, Geriatrics and Emergency Medicine, Region Västra Götaland, Sahlgrenska University Hospital/Östra, Gothenburg, Sweden.
J Intern Med. 2023 Dec;294(6):743-760. doi: 10.1111/joim.13712. Epub 2023 Aug 28.
Safety data for different anticoagulant medications in venous thromboembolism (VTE) are scarce, in particular for extended treatment.
To compare major bleeding rates depending on the choice of anticoagulation during initial (first 6 months) and extended treatment (6 months up to 5 years).
A nationwide register-based study including cancer-free patients with a first-time VTE between 2014 and 2020. Cox proportional hazards models were used to compare bleeding rates.
We included 6558 patients on warfarin, 18,196 on rivaroxaban, and 19,498 on apixaban. At 6 months, 4750 (72.4%) remained on warfarin, 11,366 (62.5%) on rivaroxaban, and 11,940 (61.2%) on apixaban. During initial treatment, major bleeding rates were 3.86 (95% CI 3.14-4.58), 2.93 (2.55-3.31), and 1.95 (1.65-2.25) per 100 patient-years for warfarin, rivaroxaban, and apixaban, respectively, yielding adjusted hazard ratios (aHRs) of 0.89 (95% CI 0.71-1.12) for rivaroxaban versus warfarin, 0.55 (0.43-0.71) for apixaban versus warfarin, and 0.62 (0.50-0.76) for apixaban versus rivaroxaban. During extended treatment, major bleeding rates were 1.55 (1.19-1.91), 1.05 (0.85-1.26), and 0.96 (0.78-1.15) per 100 patient-years for warfarin, rivaroxaban, and apixaban, respectively, with aHRs of 0.72 (0.53-0.99) for rivaroxaban versus warfarin, 0.60 (0.44-0.82) for apixaban versus warfarin, and 0.85 (0.64-1.12) for apixaban versus rivaroxaban. Previous bleeding and increasing age were risk factors for bleeding both during initial and extended treatment.
Apixaban had a lower bleeding risk than warfarin or rivaroxaban during initial treatment. During extended treatment, bleeding risk was similar for apixaban and rivaroxaban, and higher with warfarin.
静脉血栓栓塞症（VTE）中不同抗凝药物的安全性数据很少，特别是在延长治疗方面。
比较初始（前 6 个月）和延长治疗（6 个月至 5 年）期间抗凝选择对大出血发生率的影响。
这是一项基于全国登记的研究，纳入了 2014 年至 2020 年间首次发生 VTE 的无癌症患者。使用 Cox 比例风险模型比较出血率。
我们纳入了 6558 例华法林治疗患者、18196 例利伐沙班治疗患者和 19498 例阿哌沙班治疗患者。6 个月时，4750 例（72.4%）仍在接受华法林治疗，11366 例（62.5%）仍在接受利伐沙班治疗，11940 例（61.2%）仍在接受阿哌沙班治疗。在初始治疗期间，华法林、利伐沙班和阿哌沙班的大出血发生率分别为每 100 患者-年 3.86（95%CI 3.14-4.58）、2.93（2.55-3.31）和 1.95（1.65-2.25），华法林与利伐沙班相比，调整后的风险比（aHR）为 0.89（95%CI 0.71-1.12），阿哌沙班与华法林相比，aHR 为 0.55（0.43-0.71），阿哌沙班与利伐沙班相比，aHR 为 0.62（0.50-0.76）。在延长治疗期间，华法林、利伐沙班和阿哌沙班的大出血发生率分别为每 100 患者-年 1.55（1.19-1.91）、1.05（0.85-1.26）和 0.96（0.78-1.15），华法林与利伐沙班相比，aHR 为 0.72（0.53-0.99），阿哌沙班与华法林相比，aHR 为 0.60（0.44-0.82），阿哌沙班与利伐沙班相比，aHR 为 0.85（0.64-1.12）。既往出血和年龄增加是初始和延长治疗期间出血的危险因素。
阿哌沙班在初始治疗期间的出血风险低于华法林或利伐沙班。在延长治疗期间，阿哌沙班和利伐沙班的出血风险相似，而华法林的出血风险更高。
