Journal Review in Vascular Surgery: Chronic Limb Threatening Ischemia: BEST-CLI and BASIL-2 Trials

What is the best surgical treatment for a vasculopathy with critical limb threatening ischemia? In this episode of Behind the Knife the vascular surgery subspecialty team discusses two pivotal trials (BEST-CLI and BASIL-2) and how the findings of these trials can help answer this question. In this episode, we will discuss the age old question: open bypass versus best endovascular treatment.

Hosts:

Dr. Bobby Beaulieu is an Assistant Professor of Vascular Surgery at the University of Michigan

Dr. Frank Davis is an Assistant Professor of Vascular Surgery at the University of Michigan

Dr. David Schechtman is a Vascular Surgery Fellow at the University of Michigan

Dr. Drew Braet is a PGY-4 Integrated Vascular Surgery Resident at the University of Michigan

Learning Objectives

Review the definition, prevalence, and prognosis of critical limb threatening ischemia

Review basic treatment options for patients with critical limb threatening ischemia

Understand the methodology, findings, limitations, and clinical applications of the BEST-CLI trial

Understand the methodology, findings, limitations, and clinical applications of the BASIL-2 trial

Compare open bypass and best endovascular therapy for patients with critical limb threatening ischemia

References

Farber A, Menard MT, Conte MS, Kaufman JA, Powell RJ, Choudhry NK, Hamza TH, Assmann SF, Creager MA, Cziraky MJ, Dake MD, Jaff MR, Reid D, Siami FS, Sopko G, White CJ, van Over M, Strong MB, Villarreal MF, McKean M, Azene E, Azarbal A, Barleben A, Chew DK, Clavijo LC, Douville Y, Findeiss L, Garg N, Gasper W, Giles KA, Goodney PP, Hawkins BM, Herman CR, Kalish JA, Koopmann MC, Laskowski IA, Mena-Hurtado C, Motaganahalli R, Rowe VL, Schanzer A, Schneider PA, Siracuse JJ, Venermo M, Rosenfield K; BEST-CLI Investigators. Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia. N Engl J Med. 2022 Dec 22;387(25):2305-2316. doi: 10.1056/NEJMoa2207899. Epub 2022 Nov 7. PMID: 36342173. https://pubmed.ncbi.nlm.nih.gov/36342173/

Bradbury AW, Moakes CA, Popplewell M, Meecham L, Bate GR, Kelly L, et al. 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. The Lancet. 2023. 401(10390), 1798-1809. https://doi.org/10.1016/S0140-6736(23)00462-2

Conte MS Bradbury AW Kolh P et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. Eur J Vasc Endovasc Surg. 2019; 58 (109.e33.): S1-109 https://pubmed.ncbi.nlm.nih.gov/31182334/

Bradbury AW Adam DJ Bell J et al. Multicentre randomised controlled trial of the clinical and cost-effectiveness of a bypass-surgery-first versus a balloon-angioplasty-first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial. Health Technol Assess. 2010; 14: 1-210 https://pubmed.ncbi.nlm.nih.gov/20307380/

Adam DJ Beard JD Cleveland T et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005; 366: 1925-1934 https://pubmed.ncbi.nlm.nih.gov/16325694/

Bradbury AW Adam DJ Bell J et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial: an intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy. J Vasc Surg. 2010; 51: 5S-17 https://pubmed.ncbi.nlm.nih.gov/20435258/

Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH; GVG Writing Group. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019 Jun;69(6S):3S-125S.e40. doi: 10.1016/j.jvs.2019.02.016. Epub 2019 May 28. Erratum in: J Vasc Surg. 2019 Aug;70(2):662. PMID: 31159978; PMCID: PMC8365864. https://pubmed.ncbi.nlm.nih.gov/31159978/

Menard MT, Rosenfield K, Farber A. The BEST-CLI Trial: Implications of the Primary Results. Eur J Vasc Endovasc Surg. 2023 Mar;65(3):317-319. doi: 10.1016/j.ejvs.2022.12.032. Epub 2023 Jan 6. PMID: 36621707. https://pubmed.ncbi.nlm.nih.gov/36621707/

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