Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Boehringer Ingelheim Ltd., Burlington, Ontario, Canada.
Department of Epidemiology, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.
J Am Coll Cardiol. 2017 Sep 26;70(13):1573-1583. doi: 10.1016/j.jacc.2017.07.793.
Guidelines recommend long-term oral anticoagulation therapy for stroke prevention in patients with atrial fibrillation (AF). Treatment discontinuation rates in vitamin K antagonist (VKA)-treated patients are high but may be lower with non-VKA oral anticoagulant agents.
The goal of this study was to describe and explore predictors of dabigatran etexilate persistence in patients with newly diagnosed AF over 2 years of follow-up.
Consecutive patients newly diagnosed with AF and ≥1 stroke risk factor were followed up for 2 years. Dabigatran nonpersistence was defined as discontinuation of dabigatran for >30 days. A multivariable Cox regression model included region as well as patient clinical and sociodemographic characteristics to explore predictors of nonpersistence.
Eligible patients (N = 2,932) took ≥1 dabigatran dose; their mean age was 70.3 ± 10.2 years, and 55.3% were male. The 2-year probability of dabigatran persistence was 69.2%. Approximately 7% switched to a factor Xa inhibitor and 6% to a VKA. Approximately one-third of dabigatran discontinuations were primarily due to serious or nonserious adverse events. Patients from North America had the highest discontinuation risk, and Latin America had the lowest. Minimally symptomatic or asymptomatic AF and permanent AF were associated with a lower risk for dabigatran nonpersistence. Previous proton pump inhibitor use was associated with a higher risk for dabigatran nonpersistence.
Probability of treatment persistence with dabigatran after 2 years was approximately 70%. Nearly one-half of the patients who stopped dabigatran switched to another oral anticoagulant agent. Patients from North America, and those with paroxysmal, persistent, or symptomatic AF, may be at a higher risk for discontinuing dabigatran.
指南建议对患有心房颤动(AF)的患者进行长期口服抗凝治疗以预防中风。维生素 K 拮抗剂(VKA)治疗患者的停药率很高,但使用非 VKA 口服抗凝剂可能会更低。
本研究的目的是描述并探讨在 2 年随访期间新诊断为 AF 的患者持续使用达比加群酯的预测因素。
连续随访新诊断为 AF 且有≥1 个中风危险因素的患者 2 年。达比加群酯的非持续性定义为达比加群酯停药>30 天。多变量 Cox 回归模型纳入了区域以及患者的临床和社会人口统计学特征,以探讨非持续性的预测因素。
符合条件的患者(N=2932)服用了≥1 剂达比加群酯;他们的平均年龄为 70.3±10.2 岁,55.3%为男性。2 年的达比加群酯持续率为 69.2%。大约 7%的患者转为使用因子 Xa 抑制剂,6%的患者转为使用 VKA。达比加群酯停药的原因约三分之一是由于严重或非严重不良事件。来自北美的患者停药风险最高,而来自拉丁美洲的患者停药风险最低。无症状或症状轻微的 AF 和永久性 AF 与达比加群酯持续率降低相关。质子泵抑制剂的既往使用与达比加群酯的停药风险增加相关。
在 2 年后,达比加群酯的治疗持续率约为 70%。近一半停止达比加群酯治疗的患者改用另一种口服抗凝剂。来自北美的患者,以及阵发性、持续性或有症状的 AF 患者,可能更有停药风险。