AimsUse of novel anticoagulation in mechanical circulatory support is controversial. We report the rationale and design of the ApixiVad pilot trial, a pilot study testing the safety of apixaban as an anticoagulant in patients bridged to transplant (BTT) or for destination (DT) with Heartmate 3 (HM3) left ventricular assist device (LVAD).Methods and resultsApixaban has been used in small non‐randomized cohorts in LVAD patients and shown to be effective in ex vivo studies. The ApixiVAD study examines apixaban use in a multicentre, international, open‐label, randomized, controlled trial aiming to include 50 BTT or DT HM3 patients with a 1:1 randomization ratio. This event‐driven study has a maximum follow‐up period of 24 months with interim analysis at 6 months. The primary outcome is death, thromboembolic events and major bleeding, including operative bleeding and immediate transplant outcomes. The secondary outcome focuses on patients' quality of life related to anticoagulation. This investigator‐driven pilot study is not powered to determine the non‐inferiority of apixaban. An increase in primary outcome in the apixaban group of 20% will be considered a signal of harm.ConclusionsA positive outcome in the ApixiVAD study would provide the basis for future, larger, pivotal anticoagulation trials in LVAD patients.

中文翻译：

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阿哌沙班作为移植和目的地 LVAD 的桥梁 - 基本原理和研究设计：ApixiVAD 试验

目的 在机械循环支持中使用新型抗凝药物存在争议。我们报告 ApixiVad 试点试验的基本原理和设计，该试点研究测试阿哌沙班作为抗凝剂在使用 Heartmate 3 (HM3) 左心室辅助装置 (LVAD) 桥接移植 (BTT) 或目的地 (DT) 的患者中的安全性方法和结果阿哌沙班已用于 LVAD 患者的小型非随机队列，并被证明对离体学习。 ApixiVAD 研究在一项多中心、国际、开放标签、随机对照试验中检查了阿哌沙班的使用情况，该试验旨在以 1:1 的随机比例纳入 50 名 BTT 或 DT HM3 患者。这项事件驱动的研究最长随访期为 24 个月，中期分析为 6 个月。主要结局是死亡、血栓栓塞事件和大出血，包括手术出血和即刻移植结果。次要结局侧重于患者与抗凝相关的生活质量。这项由研究者驱动的试点研究无法确定阿哌沙班的非劣效性。阿哌沙班组主要结局增加 20% 将被视为危害信号。结论 ApixiVAD 研究的积极结果将为未来针对 LVAD 患者进行更大规模的关键抗凝试验奠定基础。