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S3: Plenary Session 3

SS07 - Secondary Interventions Following Open versus Endovascular Revascularization for Chronic Limb Threatening Ischemia in the BEST-CLI Trial

Thursday, June 15, 2023
8:23 AM – 8:34 AM ET
Objectives: Patients undergoing revascularization for chronic limb-threatening ischemia (CLTI) experience a high burden of target limb re-interventions. We analyzed data from the BEST-CLI randomized trial comparing initial OPEN and ENDO treatment strategies, with a focus on re-intervention related study endpoints.

Methods: In a planned secondary analysis from the BEST-CLI trial we examined the rates of major re-intervention, any re-intervention, and the composite of any re-intervention, amputation or death (RAD) by intention-to-treat (ITT) assignment in both trial cohorts (cohort 1 with suitable single segment great saphenous vein [SSGSV], N=1434; cohort 2 lacking suitable SSGSV, N= 396). We also compared the cumulative number of major and any re-intervention over time. Comparisons between treatment arms within each cohort were made using a stratified Cox model adjusted for pre-specified baseline covariates (end-stage renal disease, prior index limb revascularization, smoking, diabetes, age>80, WIfi stage, tissue loss, significant infrapopliteal disease).

Results: In cohort 1, assignment to initial OPEN treatment was associated with a significantly reduced incidence of a major limb re-intervention (HR (95% CI): 0.35 (0.27,0.47), p< 0.001), any re-intervention (HR: 0.63 [0.53, 0.75], p<.001), or RAD (HR: 0.69 [0.60-0.79], p<.001; Fig. 1). Findings were similar in cohort 2 for major re-intervention (HR: 0.47 (0.29,0.76), p=.002) or any re-intervention (HR: 0.68 [0.49, 0.95], p=.02). In both cohorts, early (30-day) limb re-interventions were notably higher for patients assigned to ENDO as compared to OPEN (15% vs 4.5% of cohort 1 subjects; 16.9% vs 5.8% of cohort 2 subjects). The cumulative incidence rate of major (IR: 0.50 (0.37,0.67), p< 0.001; Fig. 2) or any re-interventions (IR: 0.66 (0.54,0.81), p< 0.001) over time was significantly less in the OPEN group of cohort 1. Rates of re-intervention per limb salvaged were notably lower in the OPEN arms of both study cohorts (IR 0.48 for both; p<.001 and p=.03 respectively). The majority of target limb re-interventions occurred over the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial.

Figure legends:
1. Time to re-intervention, major amputation or death (RAD) by ITT, cohort 1
2. Total number of cumulative major reinterventions by ITT, cohort 1

Conclusions: Reintervention is common following revascularization for CLTI. Initial treatment with open bypass, particularly in patients with an available SSGSV conduit, is associated with a significantly lower burden of major and minor target limb reinterventions.