Bioresorbable Vascular Scaffold in Peripheral Artery Disease

Study Questions:

What are the outcomes associated with the use of the bioresorbable everolimus-eluting vascular scaffold (BVS) in peripheral artery disease (PAD)?

Methods:

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.

Results:

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.

Conclusions:

This study demonstrates the safety and efficacy of the BVS for PAD.

Perspective:

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.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Cardiac Surgery and SIHD, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Nuclear Imaging, Chronic Angina

Keywords: Angiography, Constriction, Pathologic, Coronary Occlusion, Coronary Restenosis, Dissection, Drug-Eluting Stents, Femoral Artery, Hematoma, Iliac Artery, Myocardial Revascularization, Peripheral Arterial Disease, Popliteal Artery, Stents


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