Multicenter Randomized Controlled Trial of Vitamin K Antagonist Replacement by Rivaroxaban with or without Vitamin K2 in Hemodialysis Patients with Atrial Fibrillation: the Valkyrie Study
| Autor: | Piet Van Hoenacker, Dirk De Bacquer, Bruno Van Vlem, Francis Verbeke, Joost Delanote, Rogier Caluwé, Didier De Surgeloose, Lotte Pyfferoen, Koen De Boeck, An S. De Vriese |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Vitamin K medicine.drug_class medicine.medical_treatment 030232 urology & nephrology 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Fibrinolytic Agents Rivaroxaban Clinical Research Renal Dialysis Internal medicine Atrial Fibrillation Vitamin K deficiency medicine Humans Prospective Studies Vascular Calcification Pulse wave velocity Stroke Aged Aged 80 and over business.industry Vitamin K2 Vitamin K 2 Atrial fibrillation General Medicine Vitamin K antagonist medicine.disease Antifibrinolytic Agents Nephrology Cardiology Drug Therapy Combination Female Vitamin K Deficiency Hemodialysis business Factor Xa Inhibitors medicine.drug |
| Zdroj: | J Am Soc Nephrol |
| ISSN: | 1533-3450 1046-6673 |
| DOI: | 10.1681/asn.2019060579 |
| Popis: | 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. Copyright © 2020 by the American Society of Nephrology. |
| Databáze: | OpenAIRE |
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