美国哥伦比亚大学欧文医学中心Sahil A. Parikh团队比较了药物洗脱可吸收支架与血管成形术治疗慢性肢体威胁性缺血和腘下动脉病变患者的疗效与安全性。2023年10月25日出版的《新英格兰医学杂志》发表了这项成果。

在患有慢性肢体威胁性缺血（CLTI）和腘下动脉疾病患者中，血管成形术与频繁的再干预和再狭窄导致的不良肢体预后有关。药物洗脱可吸收支架的使用对这些预后的影响尚不清楚。

在这项多中心、随机、对照试验中，261名CLTI和腘下动脉疾病患者以2：1的比例被随机分配接受依维莫司洗脱可吸收支架治疗或血管成形术治疗。主要疗效终点是在1年时不发生以下事件：目标肢体脚踝以上截肢、目标血管闭塞、临床驱动的目标病变血运重建和目标病变的二元再狭窄。主要安全终点是6个月时无重大肢体不良事件和围手术期死亡。

支架组173名患者中有135名和血管成形术组88名患者中有48名观察到主要疗效终点（即无事件发生）（Kaplan–Meier估计，74%对44%；绝对差异为30个百分点；优势单侧P<0.001）。支架组170名患者中有165人和血管成形术组90名患者中有90人观察到主要安全终点（绝对差异为−3个百分点；非劣效性单侧P<0.001）。支架组2%的患者和血管成形术组3%的患者发生了与指标手术相关的严重不良事件。

研究结果表明，在腘下动脉疾病引起的CLTI患者中，就主要疗效终点而言，使用依维莫司洗脱可吸收支架优于血管成形术。

附：英文原文

Title: Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease | NEJM

Author: Ramon L. Varcoe, Brian G. DeRubertis, Raghu Kolluri, Prakash Krishnan, David C. Metzger, Marc P. Bonaca

Issue&Volume: 2023-10-25

Abstract:

Background

Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown.

Methods

In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death.

Results

The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan–Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, 3 percentage points; 95% CI, 6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group.

Conclusions

Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point.

DOI: 10.1056/NEJMoa2305637

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2305637