Polymeris Alexandros A, Zietz Annaelle, Schaub Fabian, Meya Louisa, Traenka Christopher, Thilemann Sebastian, Wagner Benjamin, Hert Lisa, Altersberger Valerian L, Seiffge David J, Lyrer Flurina, Dittrich Tolga, Piot Ines, Kaufmann Josefin, Barone Lea, Dahlheim Ludvig, Flammer Sophie, Avramiotis Nikolaos S, Peters Nils, De Marchis Gian Marco, Bonati Leo H, Gensicke Henrik, Engelter Stefan T, Lyrer Philippe A
Department of Neurology and Stroke Center, University Hospital Basel and University of Basel, Basel, Switzerland.
Neurology and Neurorehabilitation, University Department of Geriatric Medicine Felix Platter, University of Basel, Basel, Switzerland.
Eur Stroke J. 2022 Sep;7(3):221-229. doi: 10.1177/23969873221099477. Epub 2022 May 10.
Data on the safety and effectiveness of once-daily (QD) versus twice-daily (BID) direct oral anticoagulants (DOAC) in comparison to vitamin K antagonists (VKA) and to one another in patients with atrial fibrillation (AF) and recent stroke are scarce.
Based on prospectively obtained data from the observational registry Novel-Oral-Anticoagulants-in-Ischemic-Stroke-Patients(NOACISP)-LONGTERM (NCT03826927) from Basel, Switzerland, we compared the occurrence of the primary outcome - the composite of recurrent ischemic stroke, major bleeding, and all-cause death - among consecutive AF patients treated with either VKA, QD DOAC, or BID DOAC following a recent stroke using Cox proportional hazards regression including adjustment for potential confounders.
We analyzed 956 patients (median age 80 years, 46% female), of whom 128 received VKA (13.4%), 264 QD DOAC (27.6%), and 564 BID DOAC (59%). Over a total follow-up of 1596 patient-years, both QD DOAC and BID DOAC showed a lower hazard for the composite outcome compared to VKA (adjusted HR [95% CI] 0.69 [0.48, 1.01] and 0.66 [0.47, 0.91], respectively). Upon direct comparison, the hazard for the composite outcome did not differ between patients treated with QD versus BID DOAC (adjusted HR [95% CI] 0.94 [0.70, 1.26]). Secondary analyses focusing on the individual components of the composite outcome revealed no clear differences in the risk-benefit profile of QD versus BID DOAC.
The overall benefit of DOAC over VKA seems to apply to both QD and BID DOAC in AF patients with a recent stroke, without clear evidence that one DOAC dosing regimen is more advantageous than the other.
关于每日一次（QD）与每日两次（BID）直接口服抗凝剂（DOAC）在房颤（AF）合并近期卒中患者中与维生素K拮抗剂（VKA）相比以及两者之间安全性和有效性的数据较少。
基于从瑞士巴塞尔的观察性注册研究“缺血性卒中患者新型口服抗凝剂（NOACISP）-长期研究”（NCT03826927）前瞻性获得的数据，我们使用Cox比例风险回归，包括对潜在混杂因素进行调整，比较了近期卒中后接受VKA、QD DOAC或BID DOAC治疗的连续性AF患者中主要结局——复发性缺血性卒中、大出血和全因死亡的复合结局的发生率。
我们分析了956例患者（中位年龄80岁，46%为女性），其中128例接受VKA治疗（13.4%），264例接受QD DOAC治疗（27.6%），564例接受BID DOAC治疗（59%）。在总计1596患者年的随访中，与VKA相比，QD DOAC和BID DOAC的复合结局风险均较低（调整后HR[95%CI]分别为0.69[0.48，1.01]和0.66[0.47，0.91]）。直接比较时，接受QD与BID DOAC治疗的患者复合结局风险无差异（调整后HR[95%CI]为0.94[0.70，1.26]）。针对复合结局各个组成部分的次要分析显示，QD与BID DOAC的风险效益概况无明显差异。
在近期卒中的AF患者中，DOAC相对于VKA的总体益处似乎适用于QD和BID DOAC，没有明确证据表明一种DOAC给药方案比另一种更具优势。
