Division Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Frankfurt, Germany.
Pfizer Deutschland GmbH, Berlin, Germany.
Clin Res Cardiol. 2017 Aug;106(8):618-628. doi: 10.1007/s00392-017-1098-x. Epub 2017 Mar 14.
Non-vitamin K antagonist oral anticoagulants (NOACs) are at least as effective and safe as vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF). All pivotal trials have compared NOACs to warfarin. However, other VKAs are commonly used, for instance phenprocoumon.
A retrospective cohort study using a German claims database assessed the comparative risks of bleeding leading to hospitalization during therapy with NOACs and phenprocoumon in AF patients. Endpoints consisted of major bleeding, gastrointestinal bleeding, and any bleeding. Data were collected from January 1, 2013 to March 31, 2015. Patients newly initiated on dabigatran, apixaban, rivaroxaban, or phenprocoumon were included. Hazard Ratios for bleeding events were derived from Cox proportional hazard models, adjusting for differences in baseline characteristics. Propensity score matching was performed as a sensitivity analysis.
A total of 35,013 patients were identified, including 3138 on dabigatran, 3633 on apixaban, 12,063 on rivaroxaban, and 16,179 on phenprocoumon. Patients prescribed apixaban or phenprocoumon were older compared to those on dabigatran or rivaroxaban and had a higher CHADS-VASc score. After adjusting for baseline confounders, apixaban was associated with lower risks of major bleeding (HR 0.68, 95% CI 0.51-0.90, p = 0.008), gastrointestinal bleeding (HR 0.53, 95% CI 0.39-0.72, p < 0.001), and any bleeding (HR 0.80, 95% CI 0.70-0.92, p = 0.002) compared to phenprocoumon. There were no significant differences in bleeding risk between dabigatran and phenprocoumon. Rivaroxaban was associated with more gastrointestinal bleeding (HR 1.39, 95% CI 1.21-1.60, p < 0.001) and any bleeding (HR 1.19, 95% CI 1.10-1.28, p < 0.001). Sensitivity analysis using propensity score matching confirmed these observations.
Apixaban therapy is associated with a significantly reduced risk of bleeding compared to phenprocoumon. Bleeding risk with dabigatran was similar to that of phenprocoumon but bleeding risk with rivaroxaban was higher.
非维生素 K 拮抗剂口服抗凝剂（NOACs）在预防房颤（AF）卒中方面与维生素 K 拮抗剂（VKAs）同样有效且安全。所有关键试验都将 NOACs 与华法林进行了比较。然而，其他 VKAs 也被广泛使用，例如苯丙香豆素。
一项使用德国索赔数据库的回顾性队列研究评估了在 AF 患者中使用 NOACs 和苯丙香豆素治疗时导致出血并导致住院的相对风险。终点包括大出血、胃肠道出血和任何出血。数据收集自 2013 年 1 月 1 日至 2015 年 3 月 31 日。纳入新开始使用达比加群、阿哌沙班、利伐沙班或苯丙香豆素的患者。出血事件的风险比来自 Cox 比例风险模型，根据基线特征的差异进行调整。进行倾向评分匹配作为敏感性分析。
共确定了 35013 名患者，其中达比加群 3138 名，阿哌沙班 3633 名，利伐沙班 12063 名，苯丙香豆素 16179 名。与达比加群或利伐沙班相比，服用阿哌沙班或苯丙香豆素的患者年龄更大，且 CHADS-VASc 评分更高。在调整了基线混杂因素后，与苯丙香豆素相比，阿哌沙班与较低的大出血风险（HR 0.68，95%CI 0.51-0.90，p=0.008）、胃肠道出血风险（HR 0.53，95%CI 0.39-0.72，p<0.001）和任何出血风险（HR 0.80，95%CI 0.70-0.92，p=0.002）相关。达比加群与苯丙香豆素相比，出血风险无显著差异。与利伐沙班相比，利伐沙班与更多的胃肠道出血（HR 1.39，95%CI 1.21-1.60，p<0.001）和任何出血（HR 1.19，95%CI 1.10-1.28，p<0.001）相关。使用倾向评分匹配的敏感性分析证实了这些观察结果。
与苯丙香豆素相比，阿哌沙班治疗与出血风险显著降低相关。达比加群的出血风险与苯丙香豆素相似，但利伐沙班的出血风险更高。
