Secondary Interventions Following Open vs Endovascular Revascularization for Chronic Limb-threatening Ischemia in the BEST-CLI Trial

Abstract

Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the BEST-CLI randomized trial comparing initial open and endovascular treatment strategies, with a focus on reintervention related study end points. In a planned secondary analysis from the BEST-CLI trial we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, 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 reintervention over time. Comparisons between treatment arms within each cohort were made using a stratified Cox model adjusted for prespecified baseline covariates (end-stage renal disease, prior index limb revascularization, smoking, diabetes, age >80, WIfi stage, tissue loss, and significant infrapopliteal disease). In cohort 1, assignment to initial open treatment was associated with a significantly reduced incidence of a major limb reintervention (hazard ratio [HR], 0.35; 95% confidence interval, 0.27-0.47; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or RAD (HR, 0.69; 95% CI, 0.60-0.79; P < .001) (Fig 1). Findings were similar in cohort 2 for major reintervention (HR, 0.47; 95% CI, 0.29,0.76; P = .002) or any reintervention (HR, 0.68; 95% CI, 0.49, 0.95; P = .02). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to endovascular intervention 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 (IR) of major (IR, 0.50; 95% CI, 0.37-0.67; P < .001) (Fig 2) or any reinterventions (IR, 0.66; 95% CI, 0.54-0.81; P < .001) over time was significantly less in the open group of cohort 1. Rates of reintervention 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 reinterventions occurred over the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial. Reintervention is common following revascularization for chronic limb-threatening ischemia. 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.Fig 2Total number of cumulative major reinterventions by intention to treat (ITT), cohort 1.View Large Image Figure ViewerDownload Hi-res image Download (PPT)