Antiproliferative endovascular drug technology is associated with fewer major reinterventions after femoropopliteal interventions for chronic limb-threatening ischemia.

OBJECTIVE: Conflicting data exist regarding the benefits of paclitaxel-based endovascular interventions (ENDO-Drug) for patients with chronic limb-threatening ischemia (CLTI). This analysis aims to evaluate the effect of such therapy in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

METHODS: The as treated dataset from the BEST-CLI Trial, a prospective randomized trial comparing surgical and endovascular revascularization for infrainguinal CLTI, was used to assess the association of ENDO-Drug (drug-coated balloons or drug-eluting stents) use and 3-year outcomes after initial technical success in the femoropopliteal (FP) segment. ENDO-Drug was compared with ENDO-No Drug interventions. Outcomes evaluated included major reinterventions (new bypass, interposition graft, thrombectomy, or thrombolysis), any reintervention, major adverse limb events/death, above-ankle amputations, and death.

RESULTS: There were 341 isolated FP endovascular procedures (186 ENDO-Drug, 155 ENDO-No Drug) performed in 341 patients; the majority were for tissue loss (66.3%). On Kaplan-Meier unadjusted analysis, ENDO-Drug was associated with fewer major reinterventions (16.7% vs 29.7%; P = .026), but similar any reinterventions (43.3% vs 55.6%; P = .16), major adverse limb events/death (42.4% vs 53.2%; P = .12), above-ankle amputation (14.1% vs 11.4%; P = .52), and death (21.5% vs 25%; P = .77). On risk-adjusted analysis, ENDO-Drug was associated with fewer major reinterventions (hazard ratio, 0.53; 95% confidence interval, 0.31-0.91; P = .02) and lower death (hazard ratio, 0.52; 95% confidence interval, 0.3-0.91; P = .02). Results were similar when excluding failures within 30 days. When considering any concomitant infrapopliteal interventions, there were 668 FP with or without any infrapopliteal endovascular interventions (377 ENDO-Drug, 291 ENDO-No Drug) performed. On risk-adjusted analysis, after excluding those patients who experienced revascularization failure within 30 days of the index procedure, there were no differences in outcomes overall.

CONCLUSIONS: In patients with CLTI and isolated FP disease treated using endovascular therapy, ENDO-Drug was associated with lower 3-year major reinterventions and death. Endovascular interventions using paclitaxel-based drug technology should be considered in patients with CLTI and FP occlusive disease.