伯明翰大学Catherine A Moakes研究团队的一项最新研究揭示了腿部严重缺血的普通球囊与药物球囊和支架置入术。相关论文于2025年2月24日发表于国际顶尖学术期刊《英国医学杂志》上。

目的:确定哪种原发性血管内血管重建策略对需要腘窝血管内血管重建（伴或不伴腘下血管重建）的慢性肢体缺血性患者最有效的临床治疗。

设计:三臂、开放标签、实用、多中心、随机、3期优势试验（BASIL-3）。

设置:35个英国NHS血管单位。

参与者:有慢性肢体威胁的缺血性患者，需要股腘血管内血管重建，伴或不伴腘下血管重建。

干预措施参与者:随机分配（1:1:1），分别为带或不带裸金属支架的股腘动脉球囊成形术（PBA±BMS）、带或不带裸金属支架的药物包被球囊成形术（DCBA±BMS）和药物洗脱支架（DES）作为第一种血管重建策略。

主要结果测量：主要结局是无截肢生存，定义为到第一次主要截肢或任何原因死亡的时间。次要结局包括主要结局、主要肢体不良事件、主要心脏不良事件和其他预先规定的临床和患者报告的结局措施的复合组成部分。在第一次血运重建术后30天内收集严重不良事件。

参与者:随机抽取167名（35%）女性，平均年龄71.8岁（标准差10.8）。160例中有106例（66%）严重截肢或死亡。

参与者:PBA±BMS组161例中有97例（60%），DES组159例中有93例（58%）(校正风险比：PBA±BMS vs DCBA±BMS: 0.84, 97.5%可信区间0.61 ~ 1.16，P=0.22；PBA±BMS vs DES: 0.83, 0.60 ~ 1.15， P=0.20)。两组间严重不良事件发生率无差异。

结果:2016年1月29日至2021年8月31日期间，共有481人

研究结果表明，对于接受股腘血管内血管重建（伴或不伴腘下血管重建）的慢性肢体威胁性缺血患者，DCBA±BMS和DES均未比PBA±BMS在股腘段获得显著的临床益处。

附：英文原文

Title: Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial

Author: Andrew W Bradbury, Jack A Hall, Matthew A Popplewell, Lewis Meecham, Gareth R Bate, Lisa Kelly, Jon J Deeks, Catherine A Moakes

Issue&Volume: 2025/02/24

Abstract: Objective To determine which primary endovascular revascularisation strategy represents the most clinically effective treatment for patients with chronic limb threatening ischaemia who require endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.

Design Three arm, open label, pragmatic, multicentre, randomised, phase 3 superiority trial (BASIL-3).

Setting 35 UK NHS vascular units.

Participants Patients with chronic limb threatening ischaemia who required endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.

Interventions Participants were randomly assigned (1:1:1) to femoro-popliteal plain balloon angioplasty with or without bare metal stenting (PBA±BMS), drug coated balloon angioplasty with or without bare metal stenting (DCBA±BMS), or drug eluting stenting (DES) as their first revascularisation strategy.

Main outcome measures The primary outcome was amputation free survival defined as time to first major amputation or death from any cause. Secondary outcomes included the composite components of the primary outcome, major adverse limb events, major adverse cardiac events, and other prespecified clinical and patient reported outcome measures. Serious adverse events were collected up to 30 days after the first revascularisation procedure.

Results Between 29 January 2016 and 31 August 2021, 481 participants were randomised (167 (35%) women, mean age 71.8 years (standard deviation 10.8)). Major amputation or death occurred in 106 of 160 (66%) participants in the PBA±BMS group, 97 of 161 (60%) in the DCBA±BMS group, and 93 of 159 (58%) in the DES group (adjusted hazard ratios: PBA±BMS v DCBA±BMS: 0.84, 97.5% confidence interval 0.61 to 1.16, P=0.22; PBA±BMS v DES: 0.83, 0.60 to 1.15, P=0.20). No differences in serious adverse events were reported between the groups.

Conclusions Neither DCBA±BMS nor DES conferred significant clinical benefit over PBA±BMS in the femoro-popliteal segment in patients with chronic limb threatening ischaemia undergoing endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.

DOI: 10.1136/bmj-2024-080881

Source: https://www.bmj.com/content/388/bmj-2024-080881