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

Methods

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

三臂、开放标签、实用主义、多中心、随机、第三阶段优势试验（BASIL-3）。

35 UK NHS vascular units.

35个英国国家医疗服务体系（NHS）血管外科单位。

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

需要进行股-腘动脉血管成形术，无论是否包括腘下动脉，进行血管重建的慢性肢体威胁性缺血患者。

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.

参与者被随机分配（1:1:1）接受股-腘动脉普通球囊血管成形术，有或无裸金属支架（PBA±BMS），药物涂层球囊血管成形术，有或无裸金属支架（DCBA±BMS），或药物洗脱支架（DES）作为他们的首次血管重建策略。

The primary outcome was amputation free survival defined as time to first major amputation or death from any cause.

主要结果是无截肢生存，定义为首次重大截肢或任何原因死亡的时间。

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.

次要结果包括主要结果的复合组成部分、重大不良肢体事件、重大不良心脏事件以及其他预先设定的临床和患者报告的结果指标。

Serious adverse events were collected up to 30 days after the first revascularisation procedure.

在首次血管重建手术后30天内收集严重不良事件。

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)).

在2016年1月29日至2021年8月31日期间，共有481名参与者被随机分配（其中167名（35%）为女性，平均年龄为71.8岁（标准差为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 interval0.61 to 1.16, P=0.22; PBA±BMS v DES: 0.83, 0.60 to 1.15, P=0.20).

在PBA±BMS组的160名（66%）参与者中，有106名发生了主要截肢或死亡，在DCBA±BMS组的161名（60%）参与者中，有97名发生了主要截肢或死亡，在DES组的159名（58%）参与者中，有93名发生了主要截肢或死亡（调整后的风险比：PBA±BMS与DCBA±BMS比较：0.84，97.5%置信区间0.61至1.16，P=0.22；PBA±BMS与DES比较：0.83，0.60至1.15，P=0.20）。

No differences in serious adverse events were reported between the groups.

两组之间未报告严重不良事件的差异。

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.

在慢性肢体威胁性缺血患者中，接受股-腘动脉血管成形术，无论是否包括腘下动脉血管重建，DCBA±BMS或DES与PBA±BMS相比，均未在股-腘段提供显著的临床益处。

trial_registration

ISRCTN registry ISRCTN14469736.

ISRCTN注册 ISRCTN14469736。