Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor.
Consulting for Statistics, Computing, & Analytics Research, University of Michigan, Ann Arbor.
JAMA Intern Med. 2021 Jun 1;181(6):817-824. doi: 10.1001/jamainternmed.2021.1197.
It is unclear how many patients treated with a direct oral anticoagulant (DOAC) are using concomitant acetylsalicylic acid (ASA, or aspirin) and how this affects clinical outcomes.
To evaluate the frequency and outcomes of prescription of concomitant ASA and DOAC therapy for patients with atrial fibrillation (AF) or venous thromboembolic disease (VTE).
DESIGN, SETTING, AND PARTICIPANTS: This registry-based cohort study took place at 4 anticoagulation clinics in Michigan from January 2015 to December 2019. Eligible participants were adults undergoing treatment with a DOAC for AF or VTE, without a recent myocardial infarction (MI) or history of heart valve replacement, with at least 3 months of follow-up.
Use of ASA concomitant with DOAC therapy.
Rates of bleeding (any, nonmajor, major), rates of thrombosis (stroke, VTE, MI), emergency department visits, hospitalizations, and death.
Of the study cohort of 3280 patients (1673 [51.0%] men; mean [SD] age 68.2 [13.3] years), 1107 (33.8%) patients without a clear indication for ASA were being treated with DOACs and ASA. Two propensity score-matched cohorts, each with 1047 patients, were analyzed (DOAC plus ASA and DOAC only). Patients were followed up for a mean (SD) of 20.9 (19.0) months. Patients taking DOAC and ASA experienced more bleeding events compared with DOAC monotherapy (26.0 bleeds vs 31.6 bleeds per 100 patient years, P = .01). Specifically, patients undergoing combination therapy had significantly higher rates of nonmajor bleeding (26.1 bleeds vs 21.7 bleeds per 100 patient years, P = .02) compared with DOAC monotherapy. Major bleeding rates were similar between the 2 cohorts. Thrombotic event rates were also similar between the cohorts (2.5 events vs 2.3 events per 100 patient years for patients treated with DOAC and ASA compared with DOAC monotherapy, P = .80). Patients were more often hospitalized while undergoing combination therapy (9.1 vs 6.5 admissions per 100 patient years, P = .02).
Nearly one-third of patients with AF and/or VTE who were treated with a DOAC received ASA without a clear indication. Compared with DOAC monotherapy, concurrent DOAC and ASA use was associated with increased bleeding and hospitalizations but similar observed thrombosis rate. Future research should identify and deprescribe ASA for patients when the risk exceeds the anticipated benefit.
目前尚不清楚有多少接受直接口服抗凝剂（DOAC）治疗的患者同时使用乙酰水杨酸（ASA，或阿司匹林），以及这对临床结局有何影响。
评估心房颤动（AF）或静脉血栓栓塞性疾病（VTE）患者同时使用 ASA 和 DOAC 治疗的频率和结局。
设计、地点和参与者：这项基于登记的队列研究在密歇根州的 4 个抗凝诊所进行，时间为 2015 年 1 月至 2019 年 12 月。符合条件的参与者为正在接受 DOAC 治疗的 AF 或 VTE 成年患者，无近期心肌梗死（MI）或心脏瓣膜置换术史，且至少有 3 个月的随访。
同时使用 ASA 和 DOAC 治疗。
出血（任何、非主要、主要）、血栓形成（中风、VTE、MI）、急诊就诊、住院和死亡的发生率。
在 3280 名研究队列患者中（1673 名[51.0%]男性；平均[标准差]年龄 68.2[13.3]岁），1107 名（33.8%）没有明确 ASA 用药指征的患者同时接受 DOAC 和 ASA 治疗。分析了两组经过倾向评分匹配的队列，每组各有 1047 名患者（DOAC 加 ASA 和 DOAC 单药治疗）。患者平均（标准差）随访 20.9（19.0）个月。与 DOAC 单药治疗相比，同时使用 DOAC 和 ASA 的患者发生出血事件更多（每 100 患者年 26.0 例 vs 31.6 例，P =.01）。具体而言，与 DOAC 单药治疗相比，接受联合治疗的患者非主要出血发生率显著更高（每 100 患者年 26.1 例 vs 21.7 例，P =.02）。两组的主要出血发生率相似。两组的血栓事件发生率也相似（每 100 患者年 DOAC 加 ASA 治疗组有 2.5 例，而 DOAC 单药治疗组有 2.3 例，P =.80）。接受联合治疗的患者更常住院（每 100 患者年 9.1 次 vs 6.5 次，P =.02）。
近三分之一接受 DOAC 治疗的 AF 和/或 VTE 患者在无明确指征的情况下同时使用了 ASA。与 DOAC 单药治疗相比，同时使用 DOAC 和 ASA 与出血和住院增加有关，但观察到的血栓形成率相似。未来的研究应确定并停止对风险超过预期获益的患者使用 ASA。
