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Impact of Bypass Conduit and Early Technical Failure on Revascularization for Chronic Limb-Threatening Ischemia
Michael S Conte1, Alik Farber2, Andrew Barleben3
1Division of Vascular and Endovascular Surgery, University of California, San Francisco (M.S.C.).
Insights
Single-segment great saphenous vein bypass is safer and more effective than endovascular intervention for chronic limb-threatening ischemia. This surgical approach reduces major adverse limb events and amputations, offering superior outcomes for patients.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Peripheral Artery Disease Management
Background:
- Optimal revascularization strategy for chronic limb-threatening ischemia (CLTI) remains debated.
- Comparison between open surgical bypass and endovascular intervention (ENDO) is crucial.
- Effectiveness of single-segment great saphenous vein (SSGSV) bypass, alternative conduits (AC), and ENDO needs evaluation.
Purpose of the Study:
- To compare the effectiveness of SSGSV bypass, AC bypass, and ENDO in patients with CLTI.
- To analyze outcomes based on initial revascularization strategy.
- To determine the safety and superiority of different revascularization methods.
Main Methods:
- As-treated analysis of the BEST-CLI randomized controlled trial.
- Comparison of SSGSV bypass, AC bypass, and ENDO for infrainguinal peripheral artery disease.
- Risk-adjusted analysis using multivariable Cox regression models for various endpoints including MALE, amputation, and mortality.
Main Results:
- SSGSV bypass was associated with significantly reduced major adverse limb events (MALE) or all-cause death, major amputation, and reintervention-amputation-death compared to ENDO.
- ENDO group experienced higher MALE within 30 days.
- AC bypass also showed benefits over ENDO for specific outcomes, with SSGSV superiority maintained after excluding early technical failures.
Conclusions:
- Open surgical bypass using SSGSV is safe and clinically superior to ENDO for CLTI patients suitable for either approach.
- Great saphenous vein quality assessment is vital for surgical candidates with CLTI.
- SSGSV bypass offers improved limb salvage and reduced adverse events in CLTI management.
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.
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