Veterans Affairs Eastern Colorado Health Care System, Denver, CO; University of Colorado-School of Medicine, Aurora, CO; Colorado Cardiovascular Outcomes Research Consortium, Denver, CO.
Veterans Affairs Eastern Colorado Health Care System, Denver, CO; Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; University of Colorado-School of Public Health, Aurora, CO.
Am Heart J. 2014 Jun;167(6):810-7. doi: 10.1016/j.ahj.2014.03.023. Epub 2014 Apr 5.
Dabigatran is a novel oral anti-coagulant (NOAC) that reduces risk of stroke in patients with non-valvular atrial fibrillation (NVAF). It does not require routine monitoring with laboratory testing which may have an adverse impact on adherence. We aimed to describe adherence to dabigatran in the first year after initiation and assess the association between non-adherence to dabigatran and clinical outcomes in a large integrated healthcare system.
We studied a national cohort of 5,376 patients with NVAF, initiated on dabigatran between October-2010 and September-2012 at all Veterans Affairs hospitals. Adherence to dabigatran was calculated as proportion of days covered (PDC) and association between PDC and outcomes was assessed using standard regression techniques.
Mean age of the study cohort was 71.3 ± 9.7 years; 98.3% were men and mean CHADS2 score was 2.4 ± 1.2 (mean CHA2DS2VASc score 3.2 ± 1.4). Median PDC was 94% (IQR 76%-100%; mean PDC 84% ± 22%) over a median follow-up of 244 days (IQR 140-351). A total of 1,494 (27.8%) patients had a PDC <80% and were classified as non-adherent. After multivariable adjustment, lower adherence was associated with increased risk for combined all-cause mortality and stroke (HR 1.13, 95% CI 1.07-1.19 per 10% decrease in PDC). Adherence to dabigatran was not associated with non-fatal bleeding or myocardial infarction.
In the year after initiation, adherence to dabigatran for a majority of patients is very good. However, 28% of patients in our cohort had poor adherence. Furthermore, lower adherence to dabigatran was associated with increased adverse outcomes. Concerted efforts are needed to optimize adherence to NOACs.
达比加群酯是一种新型口服抗凝药物（NOAC），可降低非瓣膜性心房颤动（NVAF）患者发生中风的风险。它不需要常规进行实验室检测，这可能会对患者的依从性产生不利影响。我们旨在描述达比加群酯在起始治疗后的第一年的依从性，并评估在一个大型综合医疗保健系统中，达比加群酯不依从与临床结局之间的关系。
我们研究了一个全国性的 NVAF 患者队列，该队列共纳入了 5376 名于 2010 年 10 月至 2012 年 9 月期间在所有退伍军人事务部医院起始使用达比加群酯的患者。使用比例天数覆盖（PDC）来评估患者对达比加群酯的依从性，并使用标准回归技术评估 PDC 与结局之间的关系。
研究队列的平均年龄为 71.3 ± 9.7 岁；98.3%为男性，平均 CHADS2 评分为 2.4 ± 1.2（平均 CHA2DS2VASc 评分为 3.2 ± 1.4）。中位 PDC 为 94%（IQR 76%-100%；平均 PDC 84% ± 22%），中位随访时间为 244 天（IQR 140-351）。共有 1494 名（27.8%）患者的 PDC＜80%，被归类为不依从。经多变量调整后，PDC 每降低 10%，全因死亡率和中风的风险增加（风险比 1.13，95%置信区间 1.07-1.19）。达比加群酯的依从性与非致死性出血或心肌梗死无关。
在起始治疗后的一年内，大多数患者对达比加群酯的依从性非常好。然而，我们队列中的 28%的患者依从性较差。此外，达比加群酯的依从性较低与不良结局的增加相关。需要共同努力，优化新型口服抗凝药物的依从性。
