Second Department of Internal Medicine, Athens Naval Hospital, Athens, Attica, Greece.
Department of Medicine, General Hospital of Nikaia Agios Panteleimon, Piraeus, Attica, Greece.
Ann Vasc Surg. 2022 Mar;80:1-11. doi: 10.1016/j.avsg.2021.07.028. Epub 2021 Oct 10.
PAD is a significant cause of morbidity and mortality affecting over 200 million people worldwide. Current guidelines recommend at least a single antiplatelet or anticoagulant agent in symptomatic PAD and lifelong antithrombotic treatment after a revascularization procedure. The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of direct oral anticoagulants (DOACs) in patients with peripheral artery disease (PAD). PAD is a significant cause of morbidity and mortality affecting over 200 million people worldwide.
The present systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Risk ratios (RR) were calculated using the random effects model.
Overall, 10 studies were included in this systematic review and meta-analysis. In 4 studies, 14,257 patients with PAD were enrolled and they were assigned to receive either aspirin (ASA)+/- clopidogrel (N = 5,894) or DOAC+/- anti-platelet (e.g., ASA, clopidogrel) (n = 8,363). Non DOAC users were found to have higher reintervention rates (RR 1.12; 95% CI 1.01-1.24; P = 0.025) compared to DOAC users. No statistically significant difference was observed between the 2 groups, in terms of major bleeding (RR 0.78; 95% CI 0.50-1.23; P = 0.285), all-cause mortality (RR 0.98; 95% CI: 0.83-1.16; P = 0.818) and cardiovascular mortality (RR: 0.99; 95% CI: 0.73-1.333; P = 0.946) mortality. In addition, two real-world studies comparing DOAC with warfarin showed decreased rates of major cardiovascular events in the DOAC group.
DOAC use alone or combined with an anti-platelet agent could be associated with lower re-intervention rates, without increasing the risk for adverse bleeding events. However, this study failed to detect any difference in terms of all-cause mortality, MACEs and MALEs between DOAC users and DOAC naïve patients. Future studies are needed to better determine the efficacy and safety of DOACs in patients with PAD.
PAD 是一种重要的发病率和死亡率原因，影响着全球超过 2 亿人。目前的指南建议在有症状的 PAD 患者中至少使用一种抗血小板或抗凝药物，并在血管重建手术后进行终身抗血栓治疗。本系统评价和荟萃分析的目的是研究直接口服抗凝剂（DOAC）在周围动脉疾病（PAD）患者中的疗效和安全性。PAD 是一种重要的发病率和死亡率原因，影响着全球超过 2 亿人。
本系统评价和荟萃分析根据系统评价和荟萃分析的首选报告项目进行。使用随机效应模型计算风险比（RR）。
总体而言，本系统评价和荟萃分析共纳入 10 项研究。其中 4 项研究纳入了 14257 例 PAD 患者，他们被分为接受阿司匹林（ASA）+/-氯吡格雷（N=5894）或 DOAC+/-抗血小板（如 ASA、氯吡格雷）（n=8363）。与 DOAC 使用者相比，非 DOAC 使用者的再介入率更高（RR 1.12；95%CI 1.01-1.24；P=0.025）。两组之间在大出血（RR 0.78；95%CI 0.50-1.23；P=0.285）、全因死亡率（RR 0.98；95%CI：0.83-1.16；P=0.818）和心血管死亡率（RR：0.99；95%CI：0.73-1.333；P=0.946）死亡率方面无统计学差异。此外，两项比较 DOAC 与华法林的真实世界研究显示，DOAC 组主要心血管事件发生率降低。
单独使用 DOAC 或与抗血小板药物联合使用可能与较低的再介入率相关，而不会增加不良出血事件的风险。然而，本研究未能检测到 DOAC 使用者和 DOAC 初治患者在全因死亡率、MACEs 和 MALEs 方面的任何差异。需要进一步的研究来更好地确定 DOAC 在 PAD 患者中的疗效和安全性。
