BACKGROUND Vitamin K antagonists (VKAs), although commonly used to reduce thromboembolic risk in atrial fibrillation, have been incriminated as probable cause of accelerated vascular calcification (VC) in patients on hemodialysis. Functional vitamin K deficiency may further contribute to their susceptibility for VC. We investigated the effect of vitamin K status on VC progression in 132 patients on hemodialysis with atrial fibrillation treated with VKAs or qualifying for anticoagulation. METHODS Patients were randomized to VKAs with target INR 2-3, rivaroxaban 10 mg daily, or rivaroxaban 10 mg daily plus vitamin K2 2000 µg thrice weekly during 18 months. Systemic dp-ucMGP levels were quantified to assess vascular vitamin K status. Cardiac and thoracic aorta calcium scores and pulse wave velocity were measured to evaluate VC progression. RESULTS Baseline dp-ucMGP was severely elevated in all groups. Initiation or continuation of VKAs further increased dp-ucMGP, whereas levels decreased in the rivaroxaban group and to a larger extent in the rivaroxaban+vitamin K2 group, but remained nevertheless elevated. Changes in coronary artery, thoracic aorta, and cardiac valve calcium scores and pulse wave velocity were not significantly different among the treatment arms. All cause death, stroke, and cardiovascular event rates were similar between the groups. Bleeding outcomes were not significantly different, except for a lower number of life-threatening and major bleeding episodes in the rivaroxaban arms versus the VKA arm. CONCLUSIONS Withdrawal of VKAs and high-dose vitamin K2 improve vitamin K status in patients on hemodialysis, but have no significant favorable effect on VC progression. Severe bleeding complications may be lower with rivaroxaban than with VKAs.

中文翻译：

---

房颤血液透析患者使用利伐沙班补充或不补充维生素K2的维生素K拮抗剂替代品的多中心随机对照试验：Valkyrie研究。

背景技术尽管维生素K拮抗剂（VKA）通常用于降低房颤的血栓栓塞风险，但已被认为是血液透析患者加速血管钙化（VC）的可能原因。功能性维生素K缺乏症可能进一步导致其对VC的易感性。我们调查了维生素K状况对132例接受VKA治疗或通过抗凝治疗的房颤血液透析患者的VC进展的影响。方法将患者随机分为18个月每周三次，每次目标INR 2-3，利伐沙班每天10 mg或利伐沙班每天10 mg加维生素K2 2000 µg的VKA。全身dp-ucMGP水平被量化以评估血管维生素K的状态。测量心脏和胸主动脉钙评分和脉搏波速度以评估VC进展。结果基线dp-ucMGP在所有组中均严重升高。VKA的启动或持续作用进一步增加了dp-ucMGP，而利伐沙班组的水平降低，而利伐沙班+维生素K2组的水平较大，但仍保持较高水平。在治疗组之间，冠状动脉，胸主动脉，心脏瓣膜钙积分和脉搏波速度的变化无明显差异。两组之间的所有原因死亡，中风和心血管事件发生率相似。除利伐沙班组与VKA组相比，危及生命和重大出血事件的发生率较低外，出血结局无明显差异。结论撤回VKA和大剂量维生素K2可改善血液透析患者的维生素K状况，但对VC进展没有明显的有利影响。利伐沙班的严重出血并发症可能比VKA少。