Bioresorbable Vascular Scaffold in Peripheral Artery Disease
What are the outcomes associated with the use of the bioresorbable everolimus-eluting vascular scaffold (BVS) in peripheral artery disease (PAD)?
The ESPRIT I investigators reported the first-in-human study of a drug-eluting BVS for treatment of PAD involving the external iliac artery (EIA) and superficial femoral artery (SFA) in 35 patients.
BVS was used for lesions predominantly located in the SFA (n = 31, 88.6%), and only a small number were in the EIA (n = 4, 11.4%). Mean lesion length was 36 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in three patients (groin hematoma, dissection). Within 2 years, there was one unrelated death, but no patient had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively. Four patients had target lesion revascularization (TLR) due to occlusion (n = 2) and stenosis (n = 2) within the study device, three at 1 year, and another one within the 2-year follow-up. Three TLRs were clinically driven, while one was performed during the 1-year required control angiogram in an asymptomatic patient. At 2 years, 71 % of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet.
This study demonstrates the safety and efficacy of the BVS for PAD.
The femoral-popliteal arteries undergo considerable torsion and bending and the long-term results with stents remain suboptimal despite considerable evolution in stent design. A biodegradable stent, theoretically, would be ideal for this segment and further studies are needed to assess if the promising results of this first-in-human study can be replicated across longer and more complex lesions.
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