Purpose: To investigate the midterm performance of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) for the treatment of symptomatic infrapopliteal atherosclerotic disease.
Methods: A single-center study prospectively enrolled 48 symptomatic patients (mean age 82.1±8.0 years; 27 men) between September 2013 and February 2018 to evaluate the Absorb everolimus-eluting BVS system in distal popliteal and tibial lesions. Mean lesion length was 20.1±10.8 mm. Following predilation, up to 2 BVS were implanted in target lesions in 55 limbs. Clinical and duplex ultrasound follow-up was performed at 1, 3, 6, 12, 24, 36, and 48 months to determine 30-day morbidity and midterm Kaplan-Meier estimates of binary restenosis, clinically-driven target lesion revascularization (CD-TLR), amputation, and mortality.
Results: Seventy-one scaffolds were implanted to treat 61 lesions. Technical success was achieved in all patients, with no amputation, death, or target limb bypass surgery within 30 days of the index procedure. There was 1 early thrombotic occlusion of 2 BVS in a previously anticoagulated patient not given antiplatelet medication after the procedure. During a mean follow-up of 24.0±15.3 months, 11 (23%) patients died; the remaining 37 were available for follow-up. Binary restenosis (50%-75%) was detected in 6 (8%) scaffolds. Primary patency estimates at 12, 24, and 36 months were 92.2%, 90.3%, and 81.1%; freedom from CD-TLR estimates were 97.2%, 97.2%, and 87.3% at the same time points. No late scaffold thrombosis has been observed. The majority of the 55 limbs (51, 93%) were clinically improved; 4 (7%) were unchanged. Thirty-six (92%) of 39 limbs treated for tissue loss achieved complete wound healing, with no major amputation (limb salvage 100%).
Conclusion: Midterm follow-up demonstrates excellent safety, patency, and freedom from CD-TLR rates using the Absorb bioresorbable vascular scaffold below the knee.
Keywords: absorbable implants; angioplasty; drug-eluting technology; everolimus; infrapopliteal artery; ischemia; lower extremity; occlusion; peripheral artery disease; polymers; stenosis; tibial artery.