From the, Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.
Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
J Intern Med. 2021 Jan;289(1):42-52. doi: 10.1111/joim.13140. Epub 2020 Jul 16.
Patient frailty amongst patients with nonvalvular atrial fibrillation (NVAF) is associated with adverse health outcomes and increased risk of mortality. Additional evidence is needed to evaluate effective and safe NVAF treatment in this patient population.
This subgroup analysis of the ARISTOPHANES study compared the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) amongst frail NVAF patients prescribed nonvitamin K antagonist oral anticoagulants (NOACs) or warfarin.
This comparative retrospective observational study of frail, older NVAF patients who initiated apixaban, dabigatran, rivaroxaban or warfarin from 01JAN2013-30SEP2015 was conducted using Medicare and 3 US commercial claims databases. To compare each drug, 6 propensity score-matched (PSM) cohorts were created. Patient cohorts were pooled from 4 databases after PSM. Cox models were used to estimate hazard ratios (HR) of S/SE and MB.
Amongst NVAF patients, 34% (N = 150 487) met frailty criteria. Apixaban and rivaroxaban were associated with a lower risk of S/SE vs warfarin (apixaban: HR: 0.61, 95% CI: 0.55-0.69; rivaroxaban: HR: 0.79, 95% CI: 0.72-0.87). For MB, apixaban (HR: 0.62, 95% CI: 0.57-0.66) and dabigatran (HR: 0.79, 95% CI: 0.70-0.89) were associated with a lower risk and rivaroxaban (HR: 1.14, 95% CI: 1.08-1.21) was associated with a higher risk vs warfarin.
Amongst this cohort of frail NVAF patients, NOACs were associated with varying rates of stroke/SE and MB compared with warfarin. Due to the lack of real-world data regarding OAC treatment in frail patients, these results may inform clinical practice in the treatment of this patient population.
非瓣膜性心房颤动（NVAF）患者的虚弱状况与不良健康结果和死亡率增加有关。需要更多的证据来评估在这一患者人群中使用非维生素 K 拮抗剂口服抗凝剂（NOACs）或华法林的 NVAF 有效和安全的治疗方法。
这项 ARISTOPHANES 研究的亚组分析比较了虚弱的 NVAF 患者服用非维生素 K 拮抗剂口服抗凝剂（NOACs）或华法林后发生卒中/全身性栓塞（S/SE）和大出血（MB）的风险。
这项使用医疗保险和 3 个美国商业索赔数据库的虚弱、老年 NVAF 患者使用阿哌沙班、达比加群、利伐沙班或华法林的回顾性比较观察性研究，从 2013 年 1 月 1 日至 2015 年 9 月 30 日进行。为了比较每种药物，创建了 6 个倾向评分匹配（PSM）队列。在 PSM 后，从 4 个数据库中合并患者队列。使用 Cox 模型估计 S/SE 和 MB 的风险比（HR）。
在 NVAF 患者中，34%（N=150487）符合虚弱标准。与华法林相比，阿哌沙班和利伐沙班与较低的 S/SE 风险相关（阿哌沙班：HR：0.61，95%CI：0.55-0.69；利伐沙班：HR：0.79，95%CI：0.72-0.87）。对于 MB，阿哌沙班（HR：0.62，95%CI：0.57-0.66）和达比加群（HR：0.79，95%CI：0.70-0.89）与较低的风险相关，而利伐沙班（HR：1.14，95%CI：1.08-1.21）与较高的风险相关，与华法林相比。
在这组虚弱的 NVAF 患者中，与华法林相比，NOACs 与不同的卒中/SE 和 MB 发生率相关。由于缺乏关于虚弱患者 OAC 治疗的真实世界数据，这些结果可能为这一患者群体的治疗提供临床依据。
