Welander Frida, Renlund Henrik, Dimény Emöke, Holmberg Henrik, Själander Anders
Department of Public Health and Clinical Medicine, Department of Research and Development-Sundsvall, Umeå University, Umeå, Sweden.
Uppsala Clinical Research Centre, Uppsala University, Uppsala, Sweden.
Clin Kidney J. 2022 Jan 28;15(6):1169-1178. doi: 10.1093/ckj/sfac022. eCollection 2022 Jun.
Observational data comparing warfarin with no treatment for patients with non-valvular atrial fibrillation (NVAF) and severely reduced glomerular filtration rate (GFR) are conflicting and randomized controlled trials (RCTs) are lacking. Most studies do not provide information on warfarin treatment quality, making them difficult to compare.
This national cohort study investigates the risk of ischaemic stroke and major bleeding during warfarin treatment compared with no oral anticoagulants in patients with NVAF, GFR category 3-5 (G3-G5) or on dialysis (G5D), with kidney transplant recipients excluded, between 2009 and 2018. Data extracted from high-quality Swedish national healthcare registries, including the Swedish Renal Registry, AuriculA-the Swedish national quality registry for atrial fibrillation and anticoagulation-and the Stroke Registry.
At enrolment of 12 106 patients, 21.4% were G3, 43.5% were G4, 11.6% were G5 and 23.6% were G5D. The mean time in the therapeutic range was 70%. Warfarin compared with no treatment showed a lower risk for ischaemic stroke for G3 {hazard ratio [HR] 0.37 [95% confidence interval (CI) 0.18-0.76]}, G4 [0.53 (0.38-0.74)] and G5 [0.49 (0.30-0.79)] and an increased risk of major bleeding in G4 [HR 1.22 (1.02-1.46)], G5 [1.52 (1.15-2.01)] and G5D [1.23 (1.00-1.51)]. All-cause mortality was more than halved on warfarin compared with no treatment in all GFR categories.
Warfarin treatment is associated with a lower risk of ischaemic stroke for patients with NVAF and G3, G4 and G5D at the cost of a higher risk of major bleeding for G4-G5D. Existing observational data are conflicting, stressing the need for RCTs on warfarin compared with no treatment in G4-G5D. Awaiting RCTs, it seems reasonable to treat selected patients on dialysis and NVAF with warfarin.
关于非瓣膜性心房颤动(NVAF)且肾小球滤过率(GFR)严重降低的患者使用华法林与不治疗进行比较的观察性数据相互矛盾,且缺乏随机对照试验(RCT)。大多数研究未提供华法林治疗质量的信息,难以进行比较。
这项全国队列研究调查了2009年至2018年间,在排除肾移植受者的情况下,NVAF、GFR为3 - 5级(G3 - G5)或接受透析(G5D)的患者使用华法林治疗与不使用口服抗凝剂相比,发生缺血性卒中和大出血的风险。数据从高质量的瑞典国家医疗保健登记处提取,包括瑞典肾脏登记处、AuriculA(瑞典国家心房颤动和抗凝质量登记处)以及卒中登记处。
在纳入的12106名患者中,21.4%为G3级,43.5%为G4级,11.6%为G5级,23.6%为G(5D)级。处于治疗范围内的平均时间为70%。与不治疗相比,华法林治疗使G3级患者发生缺血性卒中的风险降低{风险比[HR] 0.37 [95%置信区间(CI)0.18 - 0.76]},G4级为[0.53(0.38 - 0.74)],G5级为[0.49(0.30 - 0.79)],而G4级[HR 1.22(1.02 - 1.46)]、G5级[1.52(1.15 - 2.01)]和G5D级[1.23(1.00 - 1.51)]发生大出血的风险增加。在所有GFR类别中,与不治疗相比,使用华法林治疗的全因死亡率降低了一半以上。
对于NVAF且G3、G4和G5D级的患者,华法林治疗可降低缺血性卒中风险,但代价是G4 - G5D级患者大出血风险增加。现有的观察性数据相互矛盾,强调了在G4 - G5D级患者中进行华法林与不治疗比较的RCT的必要性。在等待RCT结果期间,对部分接受透析的NVAF患者使用华法林治疗似乎是合理的。