The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.
J Am Coll Cardiol. 2023 Jan 31;81(4):358-370. doi: 10.1016/j.jacc.2022.10.036.
No adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease.
This study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx.
Principal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days.
A total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR]: 1.04; 95% CI: 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation: 1.04; 95% CI: 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency: 1.31; 95% CI: 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001).
These findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease.
目前尚无足够大样本量的研究比较腔内治疗（EVT）联合支架植入与旁路手术（BSx）治疗症状性股腘动脉周围血管疾病的主要临床结局。
本研究旨在对所有比较 EVT 与 BSx 的随机对照试验的个体患者数据进行汇总分析。
5 项可用的随机对照试验的主要研究者同意汇总个体患者数据。主要终点是主要肢体不良事件，即全因死亡、主要截肢或靶肢体再干预的复合终点。次要终点包括免于截肢生存、各主要肢体不良事件组成部分和初始通畅率。早期并发症为 30 天内出血、感染或全因死亡。
共分析了 639 例患者，平均年龄为 68.1±9.1 岁，29.0%为女性。组间基线特征无显著差异。2 年时，EVT 组和 BSx 组患者在主要肢体不良事件（40.1% vs 36.4%；log-rank P=0.447；调整后 HR[aHR]：1.04；95%CI：0.80-1.36）、免于截肢生存（88.1% vs 90.0%；log-rank P=0.455；aHR 用于死亡或截肢：1.04；95%CI：0.63-1.71）和其他次要终点方面无显著差异，除初始通畅率外，EVT 组低于 BSx 组（51.2% vs 61.3%；log-rank P=0.024；aHR 用于初始通畅率丧失：1.31；95%CI：1.02-1.69）。EVT 与较低的早期并发症发生率（6.8% vs 22.6%；P<0.001）和较短的住院时间（3.1±4.2 天 vs 7.4±4.9 天；P<0.001）相关。
这些发现进一步支持 EVT 作为治疗症状性股腘动脉周围血管疾病的一种替代方案，与 BSx 相比具有疗效和安全性。
