SLR - July 2023 - Arthur Tarricone DPM MPH
Title : Delays to revascularization for patients with chronic limb-threatening ischaemiaReference : Li Q, Birmpili P, Johal AS, Waton S, Pherwani AD, Boyle JR, Cromwell DA. Delays to revascularization for patients with chronic limb-threatening ischaemia. Br J Surg. 2022 Jul 15;109(8):717-726. doi: 10.1093/bjs/znac109. PMID: 35543274.
Level of Evidence : Level 2
Scientific Literature Review
Reviewed By: Arthur Tarricone DPM MPH
Residency Program: SUNY Downstate, Brooklyn, NY
Podiatric Relevance: Critical limb ischemia (CLI) is a severe form of peripheral artery disease (PAD) that occurs when there is a significant blockage in the arteries that supply blood to the legs and feet. This condition can lead to pain, non-healing wounds, and tissue death, and it is a major cause of lower-limb amputations. Patients with CLI may present to podiatrists with non-healing wounds, pain, or changes in skin color or temperature in their feet and legs. Bypass vs endovascular approaches have both been implemented for reperfusion. This study aimed to evaluate vein bypass approach vs an endovascular approach for patients with chronic limb threatening ischemia.
Methods: BASIL-2 is an randomized (1:1, Endovascular or bypass) open-label, multicenter, phase 3 trial done in 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible participants were patients who presented to hospital-based vascular surgery units with chronic limb-threatening ischemia (CLI) due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularization procedure to restore limb perfusion. Vein bypass encompassed any vein deemed suitable by the responsible vascular surgeons could be used. Endovascular treatment, any device being used as part of standard of care in that country was permissible. Follow up was conducted at 1, 6, 12, and 24 months. The primary outcome was amputation-free survival defined as time to major (above the ankle) amputation of the trial leg or death from any cause.
Results: Between July 22, 2014, and Nov 30, 2020, 345 patients (65 [19%] women and 280 [81%] men; median age 72·5 years [IQR 62·7–79·3]) with chronic limb-threatening ischemia were randomly assigned an enrolled in the study (Vein bypass n=172 (50% , Endovascular n=173 (50%). 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group had a major amputation or died (adjusted HR 1·35 [95% CI 1·02–1·80]; p=0·037; table 2; figure 2). The median amputation-free survival was 3·3 years [IQR 2·1–4·3] in the vein bypass group and 4·4 years [IQR 3·4–5·9] in the best endovascular group. Sensitivity analyses supported increased risk of major amputation or death in the vein bypass group compared to endovascular therapy.
Conclusions: The authors conclude that a vein bypass first revascularization strategy led to a 35% increased risk of major amputation or death in patients with chronic limb-threatening ischemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularization procedure to restore limb perfusion compared with a best endovascular treatment first revascularization strategy. These conclusions will affect who we send our CLI patients to for revascularization. Additionally, this study will likely affect the way vascular surgeons, interventional radiologists and endovascular specialist treat these patients.