Hartford Hospital, Hartford, CT, USA.
Analysis Group, Inc., 1190 Avenue des Canadiens-de-Montréal, Suite 1500, Montréal, QC, H3B 0G7, Canada.
Adv Ther. 2023 May;40(5):2339-2354. doi: 10.1007/s12325-023-02483-4. Epub 2023 Mar 22.
Direct oral anticoagulants (DOACs) are essential in ischemic stroke/systemic embolism (SE) prevention among patients with nonvalvular atrial fibrillation (NVAF). This study compared the risk of ischemic stroke/SE among patients with NVAF who discontinued DOACs following the first fill ("one-and-done") relative to patients who continued DOACs beyond the first fill ("continuers").
De-identified data from Symphony Health, an ICON plc Company, PatientSource, April 1, 2017 to October 31, 2020, were used to identify adults with NVAF initiated on DOACs (index date). Patients with only one DOAC claim during the 90-day landmark period starting on the index date were classified as one-and-done and the remaining as continuers. Inverse probability of treatment weighting was used to balance baseline characteristics in the cohorts. Time from the landmark period end to the first ischemic stroke/SE event or, among those without the event, to clinical activity or data end was compared between balanced cohorts using survival analysis.
Of patients initiating DOACs, 23.6% were classified as one-and-done users. After weighting was performed, 241,159 and 238,889 patients comprised the one-and-done and continuer cohorts, respectively. At 12 months of follow-up, the probability of ischemic stroke/SE was 1.44% in the one-and-done cohort and 1.00% in the continuer cohort [hazard ratio (95% confidence interval) 1.44 (1.34-1.54); p < 0.0001]. Results at earlier and later time points and in a sensitivity analysis with a 75-day landmark period were similar.
A substantial proportion of patients were one-and-done DOAC users, which was associated with significantly higher risk of ischemic stroke/SE events. There is an unmet need to improve access and encourage continuous use of DOACs among patients with NVAF so that severe and fatal complications may be mitigated.
在非瓣膜性心房颤动（NVAF）患者中，直接口服抗凝剂（DOAC）对于预防缺血性卒中和全身性栓塞（SE）至关重要。本研究比较了 NVAF 患者在首次用药后停止 DOAC（“一次性”停药）与继续使用 DOAC 超过首次用药（“持续用药”）的患者缺血性卒中和 SE 的风险。
使用 Symphony Health（ICON plc 公司的子公司）和 PatientSource 的匿名数据，时间范围为 2017 年 4 月 1 日至 2020 年 10 月 31 日，以确定开始使用 DOAC 的成年 NVAF 患者（索引日期）。在索引日期开始的 90 天关键时期内只有一次 DOAC 用药的患者被归类为“一次性”停药，其余患者为“持续用药”。采用逆概率治疗加权法对两组患者的基线特征进行平衡。在平衡队列中，通过生存分析比较从关键时期结束到首次缺血性卒中和 SE 事件的时间（或无事件患者的临床活动或数据结束时间）。
在开始使用 DOAC 的患者中，有 23.6%的患者被归类为“一次性”停药患者。在进行加权处理后，241159 例和 238889 例患者分别归入“一次性”停药组和“持续用药”组。在 12 个月的随访中，“一次性”停药组缺血性卒中和 SE 的发生率为 1.44%，“持续用药”组为 1.00%[风险比（95%置信区间）1.44（1.34-1.54）；p<0.0001]。在更早和更晚的时间点以及采用 75 天关键时期的敏感性分析中，结果相似。
相当一部分患者为“一次性”DOAC 停药患者，这与缺血性卒中和 SE 事件的风险显著增加有关。NVAF 患者需要改善 DOAC 的获取途径并鼓励其持续使用，以减轻严重和致命的并发症。
