英国伯明翰大学医院NHS基金会信托Andrew W Bradbury团队比较了优先静脉搭桥与最佳血管内治疗血管内重建策略治疗慢性肢体威胁性缺血患者的疗效。2023年4月25日，《柳叶刀》杂志发表了这一成果。

慢性危及肢体的缺血是外周动脉疾病最严重的表现，表现为静息时的缺血性疼痛或组织损失（溃疡、坏疽或两者兼有），或两者兼有。研究组比较了静脉搭桥术优先与最佳血管内治疗优先血运重建策略在预防慢性危及肢体的缺血患者的重大截肢和死亡方面的有效性，这些患者需要进行腘下血运重建，无论是否进行额外的腹股沟下近端血运重建手术以恢复肢体灌注。

静脉搭桥术与血管成形术治疗严重下肢动脉硬化症（BASIL）-2是一项开放标签、实用、多中心、3期、随机试验，在英国（n=39）、瑞典（n=1）和丹麦（n=1）进行。因动脉粥样硬化性疾病导致的慢性危及肢体的缺血而被送往医院的血管手术室的患者，以及那些需要腘下血运重建手术以恢复肢体灌注的患者，无论是否需要额外的腹股沟下血运，则符合条件。参与者被随机分配（1:1）接受静脉搭桥术（静脉搭桥组）或最佳血管内治疗（最佳血管内治疗组），作为他们通过安全的在线随机系统进行的第一次血运重建手术。如果参与者有缺血性疼痛或组织损失，但这些疼痛或组织丢失被认为不是主要由动脉粥样硬化性外周动脉疾病引起的，则被排除在外。

大多数静脉旁路使用大隐静脉，起源于股总动脉或股浅动脉。大多数血管内介入治疗包括选择使用普通或药物洗脱支架的普通球囊血管成形术。参与者接受了至少2年的随访。参与中心在当地收集了数据。在英格兰、威尔士和瑞典，中央数据库被用来收集截肢和死亡的信息。伯明翰临床试验中心对数据进行了集中分析。主要结局是无截肢生存率，定义为首次重大（脚踝以上）截肢或全因死亡的时间，以意向治疗人群为衡量标准。通过监测首次血运重建后30天内的严重不良事件来评估安全性。

2014年7月22日至2020年11月30日，345名患有慢性肢体威胁性缺血的参与者（65名[19%]女性和280名[81%]男性；中位年龄72.5岁）被纳入试验，并被随机分配：静脉搭桥组172名（50%），最佳血管内治疗组173名（50%）。静脉搭桥组172名患者中有108名（63%）发生严重截肢或死亡，最佳血管内治疗组173名患者中有92人（53%），校正后的危险比（HR）为1.35。

静脉搭桥组172名患者中有91名（53%）死亡，最佳血管内治疗组173名患者中77名（45%）死亡（校正后HR为1.37）。在这两组患者中，最常见的发病和死亡原因包括首次血运重建后30天内发生的原因，即心血管事件（静脉搭桥组61例死亡，最佳血管内治疗组49例死亡）和呼吸系统事件（静脉旁路组25例死亡，最佳血管内治疗组23例死亡；心血管和呼吸系统死亡人数并不互斥）。

研究结果表明，在BASIL-2试验中，最佳血管内治疗优先血运重建策略与更好的无截肢生存率相关，这在很大程度上是由于最佳血管内处理组的死亡人数较少。这些数据表明，对于更多需要腘下、有或没有额外的腹股沟下近端血运重建手术以恢复肢体灌注的慢性肢体威胁性缺血患者，应考虑采用最佳的血管内治疗第一血运重建策略。

附：英文原文

Title: A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial

Author: Andrew W Bradbury, Catherine A Moakes, Matthew Popplewell, Lewis Meecham, Gareth R Bate, Lisa Kelly, Ian Chetter, Athanasios Diamantopoulos, Arul Ganeshan, Jack Hall, Simon Hobbs, Kim Houlind, Hugh Jarrett, Suzanne Lockyer, Jonas Malmstedt, Jai V Patel, Smitaa Patel, S Tawqeer Rashid, Athanasios Saratzis, Gemma Slinn, D Julian A Scott, Hany Zayed, Jonathan J Deeks

Issue&Volume: 2023-04-25

Abstract:

Background

Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion.

Methods

Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689.

Findings

Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7–79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02–1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00–1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive).

Interpretation

In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularisation strategy.

DOI: 10.1016/S0140-6736(23)00462-2

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00462-2/fulltext