Cardiovascular Department, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan; Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan; Division of Cardiology, Department of Internal Medicine, New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical Foundation), Taipei, Taiwan.
Cardiovascular Department, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan; Microscopy Core Laboratory, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.
Can J Cardiol. 2021 Jan;37(1):113-121. doi: 10.1016/j.cjca.2020.02.071. Epub 2020 Feb 19.
Evidence of clinical outcomes for oral anticoagulants and antiplatelet treatment (APT) in patients with atrial fibrillation (AF) and critical limb ischemia (CLI) is very limited.
In this nationwide retrospective cohort study collected from Taiwan National Health Insurance Research Database, 1223 patients with AF and CLI taking direct-acting oral coagulants (DOACs), warfarin, or APT were identified from June 1, 2012, to December 31, 2017. We used propensity score stabilized weighting (PSSW) to balance covariates across study groups.
After PSSW, DOAC (n = 446) was associated with lower risks of ischemic stroke/systemic embolism (IS/SE), all major adverse limb events, and all major bleeding events compared with warfarin (n = 237). DOAC was associated with lower risks of IS/SE, acute myocardial infarction (AMI), and all major adverse limb events and a comparable risk of major bleeding events compared with APT (n = 540). DOAC has a lower risk of composite net-clinical-benefit outcome (IS/SE, AMI, all major adverse limb events, plus all major bleeding events) compared with warfarin (hazard ratio [HR]: 0.48; 95% confidence interval [CI]: 0.35-0.65; P < 0.0001) or APT (HR: 0.44; 95% CI: 0.34-0.56; P < 0.0001). The composite net-clinical-benefit outcome was comparable for warfarin vs APT. The reduced risk of net-clinical-benefit outcome for DOAC vs warfarin or APT persisted in high subgroups including age > 75 years, presence of diabetes mellitus, or chronic kidney disease.
DOAC was associated with a significantly lower risk of composite net-clinical-benefit outcome than either warfarin or APT in patients with AF and concomitant CLI. Further prospective study is necessary to validate the findings in the future.
关于口服抗凝剂和抗血小板治疗(APT)在合并有房颤(AF)和严重肢体缺血(CLI)的患者中的临床结局证据非常有限。
本项全国性回顾性队列研究数据来自于台湾全民健康保险研究数据库,共纳入 1223 例自 2012 年 6 月 1 日至 2017 年 12 月 31 日期间服用直接口服抗凝剂(DOAC)、华法林或 APT 的合并有 AF 和 CLI 的患者。我们使用倾向评分稳定加权(PSSW)法在各组间平衡协变量。
经过 PSSW 调整后,与华法林相比,DOAC(n=446)降低了缺血性卒中/全身性栓塞(IS/SE)、所有主要不良肢体事件(MALE)和所有大出血事件的风险;与 APT(n=540)相比,DOAC 降低了 IS/SE、急性心肌梗死(AMI)和所有 MALE 的风险,且大出血事件风险相当。与华法林(HR:0.48;95%置信区间[CI]:0.35-0.65;P<0.0001)或 APT(HR:0.44;95%CI:0.34-0.56;P<0.0001)相比,DOAC 降低了复合净临床获益结局(IS/SE、AMI、所有 MALE 事件和所有大出血事件)的风险。华法林与 APT 的复合净临床获益结局相当。在年龄>75 岁、合并有糖尿病或慢性肾脏病的高危亚组中,DOAC 降低净临床获益结局的风险均优于华法林或 APT。未来有必要开展前瞻性研究来验证这些发现。