Secondary interventions following open versus endovascular revascularization for chronic limb threatening ischemia in the BEST-CLI trial.

Patients undergoing revascularization for CLTI experience a high burden of target limb re-interventions. We analyzed data from the BEST-CLI randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on re-intervention related study endpoints. In a planned secondary analysis 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 all index limb re-interventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models. In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb re-intervention (HR [95% CI]: 0.37 [0.28,0.49], p<0.001), any re-intervention (HR: 0.63 [0.53, 0.75], p<.001), or RAD (HR: 0.68 [0.60-0.78], p<.001). Findings were similar in cohort 2 for major re-intervention (HR: 0.53 [0.33,0.84], p=.007) or any re-intervention (HR: 0.71 [0.52, 0.98], p=.04). In both cohorts, early (30-day) limb re-interventions were notably higher for patients assigned to ENDO as compared to OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio (MR) 0.45 [95% CI: 0.34, 0.58], p < 0.001) or any target limb re-interventions (MR 0.67 [0.57, 0.80], p < 0.001) per year was significantly less in the OPEN arm of cohort 1. The mean number of re-interventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR 0.45 [0.35, 0.57], p <.001 and MR 0.66 [0.55, 0.79], p <.001 for major and all, respectively). The majority of index limb re-interventions occurred during 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 CLTI. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions.

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