Life Science Research, HealthCore, Wilmington, Delaware, USA.
Health Economics and Outcomes Research, Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, USA.
BMJ Open. 2018 Jun 30;8(6):e020676. doi: 10.1136/bmjopen-2017-020676.
With the approval of new non-vitamin K antagonist oral anticoagulants for stroke prevention in non-valvular atrial fibrillation (NVAF), it is anticipated that their introduction may change NVAF treatment patterns; however, there is limited supporting real-world evidence. This study investigated guideline-recommended oral anticoagulation (OAC) treatment and persistence in newly diagnosed patients with NVAF to understand demographic and clinical characteristics.
Retrospective observational administrative claims study in the USA.
Patients with NVAF with ≥1 pharmacy claim for OAC (warfarin, dabigatran, rivaroxaban or apixaban) and no atrial fibrillation diagnosis within 12 months prior to the first claim were identified in the HealthCore Integrated Research Database between 1 November 2010 and 30 November 2013.
45 092 patients with NVAF were included.
The proportion of OAC-treated patients was stratified by CHADS score. Treatment persistence was measured from OAC initiation to discontinuation, end of eligibility or end of study period (30 November 2014), whichever occurred first.
Almost half of the patients (41.1%) received an OAC. The proportion treated differed slightly in baseline stroke risk (CHADS<2: 39.8%; CHADS=2 or 3: 42.4%; and CHADS>3: 40.3%: p<0.001). Treated patients were slightly younger (70±12.2 vs 71±14.3 years; p<0.001), more likely male (59.7% vs 52.5%; p<0.001) and had a slightly elevated stroke risk (CHADS: 2.03±1.3 vs 1.98±1.4; p<0.001) and a lower bleeding risk (HEMORRHAGES: 2.55±1.8 vs 2.80±1.9; p<0.001) relative to untreated patients. Overall, patients with higher CHADS scores had higher HEMORRHAGES scores. The mean follow-up was 2.25 years (2.25±0.85) and 72.7% of patients discontinued OACs; nearly 25% within 3 months and 55% within 12 months. The mean time to discontinuation was 255±249 days.
The proportion of patients with NVAF who received OAC treatment was lower than previously reported and differed slightly by stroke risk. Patients with an elevated stroke risk had a higher bleeding risk, suggesting that clinicians may incorporate both in the treatment decision.
随着新型非维生素 K 拮抗剂口服抗凝剂获批用于预防非瓣膜性心房颤动（NVAF）中的卒中，预计其应用可能改变 NVAF 的治疗模式；然而，目前仅有有限的真实世界证据支持。本研究旨在调查 NVAF 新诊断患者中指南推荐的口服抗凝（OAC）治疗和持续情况，以了解人口统计学和临床特征。
美国回顾性观察性行政索赔研究。
在 2010 年 11 月 1 日至 2013 年 11 月 30 日期间，在 HealthCore 综合研究数据库中，通过≥1 项 OAC（华法林、达比加群、利伐沙班或阿哌沙班）的药房配药且在首次配药前 12 个月内无房颤诊断的 NVAF 患者被确定为研究对象。
共纳入 45092 例 NVAF 患者。
OAC 治疗患者的比例按 CHADS 评分分层。从 OAC 起始至停药、资格结束或研究期结束（2014 年 11 月 30 日）的治疗持续时间进行测量，以先发生者为准。
近一半（41.1%）的患者接受了 OAC 治疗。基线卒中风险（CHADS<2：39.8%；CHADS=2 或 3：42.4%；CHADS>3：40.3%：p<0.001）不同，治疗比例略有差异。治疗患者的年龄稍小（70±12.2 岁 vs 71±14.3 岁；p<0.001），男性比例更高（59.7% vs 52.5%；p<0.001），卒中风险稍高（CHADS：2.03±1.3 vs 1.98±1.4；p<0.001），出血风险稍低（HEMORRHAGES：2.55±1.8 vs 2.80±1.9；p<0.001）。总体而言，CHADS 评分较高的患者 HEMORRHAGES 评分较高。平均随访时间为 2.25 年（2.25±0.85），72.7%的患者停用了 OAC；近 25%的患者在 3 个月内停用，55%的患者在 12 个月内停用。平均停药时间为 255±249 天。
NVAF 患者接受 OAC 治疗的比例低于此前报道，且略受卒中风险影响。卒中风险较高的患者出血风险更高，这表明临床医生可能会将两者都纳入治疗决策中。
