BACKGROUND Atrial fibrillation is common in individuals receiving dialysis. The role of oral anticoagulation in this population is uncertain given its exclusion from previous seminal clinical trials. Our objective was to determine the feasibility of performing a large definitive trial to establish the optimal anticoagulation strategy in individuals with atrial fibrillation receiving dialysis. METHODS The SAFE-D trial was a parallel-group, open-label, allocation-concealed, pilot randomized control trial that took place at 28 centres in Canada and Australia. The trial included adults (≥18 y) undergoing dialysis with a history of non-valvular atrial fibrillation who met the CHADS-65 criteria. Participants were randomized 1:1:1 to receive dose-adjusted warfarin, apixaban 5 mg twice daily, or no oral anticoagulation and followed for 26 weeks. The primary outcomes evaluated the following measures of feasibility: a) recruitment of the target population within 2 years from the start of the trial; and b) adherence of >80% of randomized patients to the allocated treatment strategy at the conclusion of follow-up. Secondary outcomes included stroke and bleeding. RESULTS From December 2019 through June 2022, 151 patients were enrolled and randomized to apixaban (n =51), warfarin (n=52) or no oral anticoagulation (n=48). Allowing for pauses related to the COVID pandemic, recruitment was completed in 30 months, and 123 (83%) of participants completed follow-up in their allocated treatment arm. There was one adjudicated stroke event. Eight participants had a major bleeding event (4 warfarin, 2 apixaban, 2 no oral anticoagulation). Death occurred in 15 participants (9 warfarin, 2 apixaban, 4 no oral anticoagulation). Time in the therapeutic range for warfarin recipients was 58% (IQR 47%-70%). CONCLUSIONS We have demonstrated the feasibility of recruitment and adherence in a trial that compared different anticoagulation strategies in patients with atrial fibrillation receiving dialysis.

中文翻译：

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接受透析的心房颤动患者的抗凝治疗：一项初步随机对照试验。


背景 心房颤动在接受透析的个体中很常见。鉴于口服抗凝药被排除在以前的开创性临床试验之外，因此在该人群中的作用尚不确定。我们的目的是确定进行一项大型确定性试验的可行性，以建立接受透析的心房颤动个体的最佳抗凝策略。方法 SAFE-D 试验是一项平行组、开放标签、分配隐藏、试点随机对照试验，在加拿大和澳大利亚的 28 个中心进行。该试验包括接受透析且有非瓣膜性心房颤动病史且符合 CHADS-65 标准的成人 （≥18 岁）。参与者以 1：1：1 的比例随机接受剂量调整后的华法林、阿哌沙班 5 mg、每日两次或不口服抗凝药，随访 26 周。主要结局评估了以下可行性指标： a） 试验开始后 2 年内招募目标人群;b） 在随访结束时，>80% 的随机患者对分配的治疗策略的依从性。次要结局包括卒中和出血。结果 从 2019 年 12 月到 2022 年 6 月，151 例患者入组并随机分配至阿哌沙班组 （n = 51） 、华法林组 （n=52） 或不口服抗凝药组 （n=48）。考虑到与 COVID 大流行相关的暂停，招募在 30 个月内完成，123 名 （83%） 参与者在其分配的治疗组中完成了随访。有 1 例经裁定的中风事件。8 名参与者发生了大出血事件 （4 名华法林，2 名阿哌沙班，2 名无口服抗凝药）。15 名参与者死亡 （9 名华法林，2 名阿哌沙班，4 名无口服抗凝药）。 华法林受者在治疗范围内的时间为 58% （IQR 47%-70%）。结论 我们在一项试验中证明了募集和依从性的可行性，该试验比较了接受透析的心房颤动患者的不同抗凝策略。