Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.
Department of Neurosurgery, Hyogo College of Medicine, Nishinomiya, Japan.
Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1321-1331. doi: 10.1002/pds.5228. Epub 2021 May 3.
Antiplatelet therapy (APT) is challenging in patients taking oral anticoagulants (OACs) for nonvalvular atrial fibrillation (NVAF) with concomitant atherosclerotic diseases. We scrutinized the generalizability of recent randomized clinical trials showing OAC use alone was superior to OAC plus antiplatelet use in patients with NVAF and coronary artery diseases (CAD).
We conducted a historical multicenter registry at 71 centers in Japan. The inclusion criterion was taking OACs for NVAF. The exclusion criteria were mechanical heart valves or history of pulmonary thrombosis or deep vein thrombosis. Consecutive patients (N = 7826) were registered in February 2013 and were followed until February 2017. The co-primary endpoints were ischemic events and major bleedings. Secondary endpoints were ischemic stroke, hemorrhagic stroke, and all-cause mortality.
The mean patient age was 73 years; 67% were men. Antiplatelets were administered in 25% of patients and 27% had history of CAD. Cumulative incidences of ischemic events and major bleedings at 4 years were 5.9% and 9.6% in the APT group and 5.3% and 7.0% in the No-APT group, respectively. The adjusted hazard ratios (HRs) (95% confidence intervals [CIs]) of the APT group for ischemic events and major bleedings were 1.12 (0.84-1.49) and 1.26 (1.01-1.57), respectively. The adjusted HRs (95% CIs) for ischemic stroke, hemorrhagic stroke, and all-cause mortality were 1.16 (0.86-1.57), and 1.31 (0.70-2.48), and 1.02 (0.82-1.26), respectively.
APT in patients taking OACs for NVAF did not prevent ischemic events but significantly increased major bleedings in the real-world setting.
在伴有动脉粥样硬化疾病的非瓣膜性心房颤动（NVAF）患者中，抗血小板治疗（APT）具有挑战性，这些患者正在服用口服抗凝剂（OAC）。我们仔细研究了最近的随机临床试验结果，这些结果表明，在 NVAF 和冠状动脉疾病（CAD）患者中，单独使用 OAC 优于 OAC 加抗血小板治疗。
我们在日本的 71 个中心进行了一项历史性的多中心登记研究。纳入标准为服用 OAC 治疗 NVAF。排除标准为机械性心脏瓣膜或肺血栓栓塞或深静脉血栓形成病史。连续患者（N=7826）于 2013 年 2 月登记，并随访至 2017 年 2 月。主要共同终点为缺血事件和主要出血。次要终点为缺血性卒中和出血性卒中和全因死亡率。
患者平均年龄为 73 岁，67%为男性。25%的患者使用抗血小板药物，27%的患者有 CAD 病史。APT 组 4 年时缺血事件和主要出血的累积发生率分别为 5.9%和 9.6%，No-APT 组分别为 5.3%和 7.0%。APT 组缺血事件和主要出血的调整后风险比（HR）（95%置信区间[CI]）分别为 1.12（0.84-1.49）和 1.26（1.01-1.57）。缺血性卒中和出血性卒中和全因死亡率的调整后 HR（95%CI）分别为 1.16（0.86-1.57）和 1.31（0.70-2.48）和 1.02（0.82-1.26）。
在服用 OAC 治疗 NVAF 的患者中，APT 并未预防缺血事件，但在真实世界环境中显著增加了大出血的风险。
