Clinical Research Directory

Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis

Femoropopliteal in-stent restenosis (ISR) remains an important cause of recurrent symptoms and repeat revascularization after lower-extremity endovascular treatment. Drug-coated balloons (DCBs) avoid an additional permanent metallic layer, whereas drug-eluting stents provide mechanical scaffolding with local antiproliferative drug delivery. Direct prospective comparative-effectiveness evidence in symptomatic femoropopliteal ISR remains limited. DEFIER is a prospective, multicenter observational comparative-effectiveness cohort study enrolling up to 600 adults with symptomatic Rutherford category 2-5 femoropopliteal ISR. Treatment is selected by the treating physician as part of routine clinical care and is not assigned by the research protocol. After guidewire crossing and lesion preparation, patients for whom both strategies remain clinically feasible enter the primary comparative cohort. The DCB-first strategy uses IN.PACT Admiral or AcoArt Orchid 0.035, with protocol-defined focal bare-metal bailout stenting permitted when clinically required. The Eluvia-first strategy uses the Eluvia drug-eluting vascular stent. Participants will be followed for 24 months. The primary outcome is the cumulative incidence of first clinically driven target lesion revascularization (CD-TLR) through 24 months. Comparative analyses will use a prespecified target-trial framework and propensity-score overlap weighting, with death and major target-limb amputation treated as competing events.