Patients receiving left ventricular assist device (LVAD) support require long-term anticoagulation to reduce the risk of thromboembolic complications. Apixaban is a direct oral anticoagulant that has become first-line therapy; however, its safety in LVAD recipients has not been well described. This study sought to investigate whether, in patients with a fully magnetically levitated LVAD, treatment with apixaban would be feasible and comparable with respect to safety and freedom from the primary composite outcome of death or major hemocompatibility-related adverse events (HRAEs) (stroke, device thrombosis, major bleeding, aortic root thrombus, and arterial non–central nervous system thromboembolism) as compared with treatment with warfarin. The DOAC LVAD (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices) trial was a phase 2, open label trial of LVAD recipients randomized 1:1 to either apixaban 5 mg twice daily or warfarin therapy. All patients were required to take low-dose aspirin. Patients were followed up for 24 weeks to evaluate the primary composite outcome. A total of 30 patients were randomized: 14 patients to warfarin and 16 patients to apixaban. The median patient age was 60 years (Q1-Q3: 52-71 years), and 47% were Black patients. The median time from LVAD implantation to randomization was 115 days (Q1-Q3: 56-859 days). At 24 weeks, the primary composite outcome occurred in no patients receiving apixaban and in 2 patients (14%) receiving warfarin ( 0.12); these 2 patients experienced major bleeding from gastrointestinal sources. Anticoagulation with apixaban was feasible in patients with an LVAD without an excess of HRAEs or deaths. This study informs future pivotal clinical trials evaluating the safety and efficacy of apixaban in LVAD recipients. (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices [DOAC LVAD]; )

中文翻译：

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左心室辅助装置中直接口服抗凝剂阿哌沙班的血液相容性评估：DOAC LVAD 研究


接受左心室辅助装置 (LVAD) 支持的患者需要长期抗凝治疗，以降低血栓栓塞并发症的风险。阿哌沙班是一种直接口服抗凝剂，已成为一线治疗药物；然而，其在 LVAD 接受者中的安全性尚未得到很好的描述。本研究旨在调查对于完全磁悬浮 LVAD 患者，阿哌沙班治疗是否可行，并且在安全性和免于死亡或主要血液相容性相关不良事件 (HRAE)（中风、与华法林治疗相比，装置血栓形成、大出血、主动脉根部血栓和动脉非中枢神经系统血栓栓塞）。 DOAC LVAD（左心室辅助装置中直接口服抗凝剂阿哌沙班的血液相容性评估）试验是一项 2 期、开放标签试验，受试者以 1:1 的比例随机接受阿哌沙班 5 mg 每天两次或华法林治疗。所有患者均需服用小剂量阿司匹林。对患者进行 24 周的随访以评估主要综合结果。共有 30 名患者被随机分组​​：14 名患者接受华法林治疗，16 名患者接受阿哌沙班治疗。患者中位年龄为 60 岁（第一季度至第三季度：52-71 岁），其中 47% 是黑人患者。从 LVAD 植入到随机分组的中位时间为 115 天（第一季度至第三季度：56-859 天）。 24 周时，主要复合结局在接受阿哌沙班治疗的患者中没有出现，而在接受华法林治疗的患者中则有 2 名 (14%) 出现 (0.12)；这两名患者经历了胃肠道大出血。对于 LVAD 患者，使用阿哌沙班抗凝是可行的，且不会出现过多的 HRAE 或死亡。 这项研究为未来评估阿哌沙班在 LVAD 接受者中的安全性和有效性的关键临床试验提供了信息。 （左心室辅助装置中直接口服抗凝剂阿哌沙班的血液相容性评估 [DOAC LVAD]；）