Charité - Universitätsmedizin Berlin, Institute of Clinical Pharmacology and Toxicology, Charitéplatz 1, 10117 Berlin, Germany.
Bayer AG, Müllerstraße 178, 13342 Berlin, Germany.
Int J Cardiol. 2024 Jun 1;404:131894. doi: 10.1016/j.ijcard.2024.131894. Epub 2024 Mar 2.
Non-vitamin K antagonist oral anticoagulants (NOACs) have largely supplanted vitamin K antagonists (VKAs) for oral anticoagulation in non-valvular atrial fibrillation (NVAF). However, data on the real-world effectiveness of NOACs vs. phenprocoumon, a VKA widely used in Germany, are limited. The RELOADED study aimed to compare effectiveness of factor Xa NOACs and phenprocoumon in NVAF in clinical practice.
Patients who started on a factor Xa NOAC or phenprocoumon for NVAF during the study period were enrolled from the Institute for Applied Healthcare Research Berlin. Patients were followed from first prescription until the end of exposure or available data. Primary outcomes were analyzed by Cox proportional hazard regression models and included ischemic stroke and systemic embolism for effectiveness, and intracranial hemorrhage (ICH) for safety. Subgroups of interest were patients with diabetes and patients with renal impairment.
The total study population was 64,920; 36.3% of patients initiated phenprocoumon, 34.4% initiated rivaroxaban, 25.0% apixaban, and 4.4% edoxaban. Treatment with phenprocoumon is associated with a similar risk of ischemic stroke/systemic embolism as treatment with rivaroxaban or apixaban; while rivaroxaban (adjusted hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.43-0.75) and apixaban (adjusted HR 0.43, 95% CI 0.31-0.6) were associated with a lower risk of ICH compared to phenprocoumon in NVAF patients. The use of rivaroxaban and apixaban was associated with a lower risk of developing kidney failure in patients with diabetes or renal impairment in comparison to those treated with phenprocoumon.
The factor Xa NOACs rivaroxaban and apixaban demonstrated similar effectiveness and lower rates of ICH compared with phenprocoumon in this study.
非维生素 K 拮抗剂口服抗凝剂（NOACs）在非瓣膜性心房颤动（NVAF）中已基本替代了维生素 K 拮抗剂（VKAs）用于口服抗凝治疗。然而，关于 NOACs 与在德国广泛使用的 VKA 苯丙香豆素的真实世界有效性的数据有限。RELOADED 研究旨在比较 NVAF 中新型口服抗凝剂与苯丙香豆素的有效性。
本研究从柏林应用医疗保健研究所招募了在研究期间开始使用新型口服抗凝剂或苯丙香豆素治疗 NVAF 的患者。患者从首次处方开始随访，直至暴露结束或获得可用数据。主要结局通过 Cox 比例风险回归模型进行分析，包括有效性的缺血性卒中和全身性栓塞，以及安全性的颅内出血（ICH）。感兴趣的亚组为患有糖尿病和肾功能损害的患者。
总研究人群为 64920 例；36.3%的患者开始使用苯丙香豆素，34.4%的患者开始使用利伐沙班，25.0%的患者开始使用阿哌沙班，4.4%的患者开始使用依度沙班。与苯丙香豆素治疗相比，利伐沙班（调整后的风险比 [HR] 0.57，95%置信区间 [CI] 0.43-0.75）和阿哌沙班（调整后的 HR 0.43，95% CI 0.31-0.6）治疗与缺血性卒中和全身性栓塞的风险相似，而利伐沙班和阿哌沙班与苯丙香豆素相比，NVAF 患者的 ICH 风险降低。与苯丙香豆素治疗相比，在患有糖尿病或肾功能损害的患者中，使用利伐沙班和阿哌沙班与发生肾衰竭的风险降低相关。
在这项研究中，与苯丙香豆素相比，新型口服抗凝剂利伐沙班和阿哌沙班在 NVAF 患者中具有相似的疗效和更低的 ICH 发生率。
