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.