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Randomized Controlled Trial
. 2025 Mar;18(3):e014716.
doi: 10.1161/CIRCINTERVENTIONS.124.014716. Epub 2025 Mar 18.

Impact of Bypass Conduit and Early Technical Failure on Revascularization for Chronic Limb-Threatening Ischemia

Michael S Conte  1 , Alik Farber  2 , Andrew Barleben  3 , Emiliano Chisci  4 , Gheorghe Doros  5 , Vikram S Kashyap  6 , Ahmed Kayssi  7 , Philippe Kolh  8 , Carla C Moreira  9 , Timothy Nypaver  10 , Kenneth Rosenfield  11 , Vincent L Rowe  12 , Andres Schanzer  13 , Niten Singh  14 , Jeffrey J Siracuse  2 , Michael B Strong  15 , Matthew T Menard  15
Affiliations
Randomized Controlled Trial

Impact of Bypass Conduit and Early Technical Failure on Revascularization for Chronic Limb-Threatening Ischemia

Michael S Conte et al. Circ Cardiovasc Interv. 2025 Mar.

Abstract

Background: The optimal strategy for lower extremity revascularization (surgical bypass versus endovascular intervention) in patients with chronic limb-threatening ischemia (CLTI) is unclear. We examined the effectiveness of open surgical bypass using single-segment great saphenous vein conduit (SSGSV), alternative conduits (AC), or endovascular interventions (ENDO) among patients with CLTI deemed acceptable for either open surgical bypass or ENDO treatment.

Methods: This was a planned as-treated analysis of the multicenter BEST-CLI (Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia) randomized controlled trial comparing open surgical bypass and ENDO for CLTI due to infrainguinal peripheral artery disease. Outcomes were tabulated based on the initial revascularization received: SSGSV bypass, AC bypass, and ENDO. Analyses were performed for all treated patients and then excluding those who experienced early technical failure. Multivariable Cox regression models were used. End points included the primary trial outcome (major adverse limb event [MALE] or all-cause death), major amputation, MALE at any time or perioperative (30-day) death, reintervention-amputation-death, and all-cause mortality.

Results: Among 1780 patients with CLTI, treatments received included SSGSV bypass (n=621), AC bypass (n=236), and ENDO (n=923) procedures. There were no significant differences in 30-day mortality, major adverse cardiovascular events, or serious adverse events; subjects treated with ENDO experienced greater MALE within 30 days (13.1% versus 2.7%, 3% for SSGSV, AC; P<0.001). On risk-adjusted analysis, SSGSV bypass was associated with reduced MALE or all-cause death (hazard ratio, 0.65 [95% CI, 0.56-0.76]; P<0.001), major amputation (hazard ratio, 0.70 [95% CI, 0.52-0.94]; P=0.017), MALE or perioperative death (hazard ratio, 0.51 [0.41-0.62]; P<0.001), and reintervention-amputation-death (hazard ratio, 0.69 [95% CI, 0.61-0.79]; P<0.001). AC bypass was associated with reduced MALE or perioperative death and reintervention-amputation-death compared with ENDO. Significant benefits of SSGSV over ENDO remained when excluding patients who experienced early technical failure. There were no significant differences in long-term mortality by initial treatment received. When analyzed by the level of disease treated, the improved outcomes of SSGSV were greatest among patients who underwent femoropopliteal revascularization.

Conclusions: Analysis of as-treated outcomes from the BEST-CLI trial demonstrates the safety and clinical superiority of bypass with SSGSV among patients with CLTI who were deemed suitable for either open surgical bypass or ENDO revascularization. Assessment of great saphenous vein quality should be incorporated into the evaluation of patients with CLTI who are surgical candidates.

Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02060630 and NCT02060630.

Keywords: amputation; chronic limb-threatening ischemia; endovascular procedures; limb salvage; saphenous vein; vascular grafting.

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Conflict of interest statement

Dr Conte serves on the Data Safety Monitoring Board for Abbott Vascular and acts as a consultant for BioGenCell. Dr Farber is a grant recipient from the Novo Nordisk Foundation and provides consulting services to Sanifit, LeMaitre, and BioGenCell. He also serves on the advisory board for Dialysis-X and iThera Medical. Dr Rosenfield holds consulting or scientific advisory board positions with Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, Becton Dickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, Inspire MD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Medtronic, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Truvic, Vasorum, and Vumedi; has equity or stock options in Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Crossliner, Cruzar Systems, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Vasorum, and Vumedi; has received research grants from the NIH, Abiomed, Boston Scientific, Novo Nordisk Foundation, Penumbra, and Gettinge-Atrium; and is a member of the Board of Directors for The National PERT (Pulmonary Embolism Response Team) Consortium. Dr Singh is a member of the Medtronic Regional Scientific Advisory Board. Dr Siracuse has received an education grant from WL Gore to Boston University and an education grant from Becton Dickinson to Boston University. Dr Menard serves as an advisor to Janssen. The other authors report no conflicts.

References

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