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

N/ANot Yet RecruitingNCT07277218

Chunshui He600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Femoropopliteal In-Stent Restenosis (ISR)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Age \>18 years. Willing and able to provide written informed consent. Rutherford Clinical Category 2-5. Angiographically confirmed ≥50% stenosis or occlusion within a previously implanted superficial femoral or proximal popliteal artery stent more than 30 days after implantation. The target lesion is within the previously stented segment or extends no more than 3 cm proximally or distally beyond the prior stent. Total target lesion length ≤30 cm. At least one patent below-the-knee runoff vessel. Willing and able to complete follow-up through 24 months. After lesion preparation, both the DCB-first and Eluvia-first strategies remain clinically feasible. Exclusion Criteria: Pregnancy or lactation. Rutherford Clinical Category 0 or 6. Target lesion stenosis \<50%. Target lesion length \>30 cm. Severe calcification precluding endovascular treatment. Acute limb ischemia or acute thrombosis of the target limb. Untreated hemodynamically significant aorto-iliac inflow disease. Cerebrovascular accident within 60 days before the index procedure. Contraindication to required antiplatelet or anticoagulant therapy. Inability or unwillingness to provide informed consent. Life expectancy \<2 years or another factor making completion of follow-up unlikely. Persistent post-preparation anatomy that mandates one treatment strategy and therefore eliminates clinical equipoise.

Outcomes

Primary Outcomes

Clinically-Driven Target Lesion Revascularization (CD-TLR)

Clinically driven target lesion revascularization (CD-TLR) is defined as repeat percutaneous or surgical revascularization of the target lesion, defined as the treated segment plus 5 mm proximally and distally, for ≥50% restenosis or occlusion accompanied by recurrent or worsening limb symptoms, Rutherford-category deterioration, ABI/TBI decline consistent with hemodynamic worsening, including an ABI decline ≥0.15 from the post-procedure reference when applicable, or failure or worsening of tissue loss in patients with chronic limb-threatening ischemia. Events will be independently adjudicated.

Time frame: 24 months post-procedure