近日，瑞士苏黎世大学医院Stefano Barco团队报道了西罗莫司涂层球囊血管成形术治疗腹股沟下动脉疾病的疗效。2026年3月30日，《新英格兰医学杂志》发表了这一成果。

腹股沟下动脉疾病中使用西罗莫司涂层球囊血管成形术是否能降低主要不良肢体事件的发生率，目前尚不明确。

在这项前瞻性、开放标签、非劣效性试验中，研究组采用了预设的序贯检验策略以验证优效性，并进行盲态结局判定。将腹股沟下动脉疾病患者按1:1比例随机分配，分别接受西罗莫司涂层球囊或普通球囊血管成形术。主要结局是随机分组后1年内发生以下事件的复合终点：需进行非计划的靶肢体大截肢，或因严重肢体缺血而对靶病变进行血管内或外科血运重建。关键次要结局是随机分组后1年内发生以下事件的复合终点：任何非计划的靶肢体截肢，或因严重或非严重肢体缺血对靶病变进行血运重建。非劣效性界值为5个百分点。主要安全性结局是随机分组后1年内全因死亡。

共1252例患者纳入试验：626例分配至西罗莫司涂层球囊组，626例分配至普通球囊组。患者中位年龄为75岁，35.1%为女性。西罗莫司涂层球囊组有55例患者（8.8%）发生主要结局事件，普通球囊组有94例患者（15.0%）发生主要结局事件（风险差异的中位无偏估计值为4.9个百分点；95%置信区间为8.5至1.3；非劣效性P<0.001；优效性P=0.009）。关键次要结局事件发生率分别为144例（23.0%）和193例（30.8%）（风险差异7.8个百分点；95%置信区间12.7至2.9；P=0.002）。西罗莫司涂层球囊组74例患者（11.8%）死亡，普通球囊组80例患者（12.8%）死亡（风险差异1.0个百分点；95%置信区间-4.6至2.7；P=0.67）。两组不良事件发生率似乎相差不大。

研究结果表明，在接受血管内治疗的腹股沟下动脉疾病患者中，与普通球囊血管成形术相比，使用西罗莫司涂层球囊血管成形术可降低1年时主要不良肢体事件的发生率。

附：英文原文

Title: Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease

Author: Stefano Barco, Rolf P. Engelberger, Ulrike Held, Riccardo M. Fumagalli, Alexandru Grigorean, Daniel Hayoz, Mario Münger, Tim Sebastian, Roman Stadler, Davide Voci, Simon Wolf, Frédéric Baumann, Tobias Tritschler, Conrad von Stempel, Daniel Périard, Nils Kucher

Issue&Volume: 2026-03-30

Abstract:

Background

Whether sirolimus-coated balloon angioplasty for infrainguinal artery disease reduces the incidence of major adverse limb events remains unknown.

Methods

In this prospective, open-label, noninferiority trial with a prespecified sequential testing strategy for superiority and blinded outcome adjudication, we randomly assigned patients with infrainguinal artery disease in a 1:1 ratio to undergo angioplasty with a sirolimus-coated balloon or with an uncoated balloon. The primary outcome was a composite of unplanned major amputation affecting the target limb or endovascular or surgical revascularization of the target lesion for critical limb ischemia within 1 year after randomization. The key secondary outcome was a composite of any unplanned amputation affecting the target limb or revascularization of the target lesion for critical or noncritical limb ischemia within 1 year after randomization. The noninferiority margin was 5 percentage points. The primary safety outcome was death from any cause within 1 year after randomization.

Results

A total of 1252 patients were enrolled in the trial: 626 patients were assigned to the sirolimus-coated–balloon group and 626 to the uncoated-balloon group. The median age of the patients was 75 years, and 35.1% were women. A primary-outcome event occurred in 55 patients (8.8%) in the sirolimus-coated–balloon group and in 94 patients (15.0%) in the uncoated-balloon group (median unbiased estimate of risk difference, 4.9 percentage points; 95% confidence interval [CI], 8.5 to 1.3; P<0.001 for noninferiority; P=0.009 for superiority); a key secondary-outcome event occurred in 144 patients (23.0%) and 193 patients (30.8%), respectively (risk difference, 7.8 percentage points; 95% CI, 12.7 to 2.9; P=0.002). Death occurred in 74 patients (11.8%) in the sirolimus-coated–balloon group and in 80 patients (12.8%) in the uncoated-balloon group (risk difference, 1.0 percentage points; 95% CI, 4.6 to 2.7; P=0.67). The incidence of adverse events appeared to be similar in the two groups.

Conclusions

Among patients with infrainguinal artery disease undergoing endovascular treatment, angioplasty with sirolimus-coated balloons led to a lower incidence of major adverse limb events at 1 year than angioplasty with uncoated balloons.

DOI: NJ202603300000022

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2600360