Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results

• Published in: JACC. Cardiovascular interventions 2016-06, Vol.9 (11), p.1178-1187
• Main Authors: Lammer, Johannes, Bosiers, Marc, Deloose, Koen, Schmidt, Andrej, Zeller, Thomas, Wolf, Florian, Lansink, Wouter, Sauguet, Antoine, Vermassen, Frank, Lauwers, Geert, Scheinert, Dierk, Popma, Jeffrey J, McGreevy, Robert, Rapoza, Richard, Schwartz, Lewis B, Jaff, Michael R
• Format: Article
• Language: English
• Subjects: Absorbable Implants; Aged; Angiography; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Ankle Brachial Index; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Coated Materials, Biocompatible; Everolimus - administration & dosage; Everolimus - adverse effects; Exercise Tolerance; Feasibility Studies; Female; Femoral Artery - diagnostic imaging; Femoral Artery - physiopathology; Humans; Iliac Artery - diagnostic imaging; Iliac Artery - physiopathology; Intermittent Claudication - diagnostic imaging; Intermittent Claudication - physiopathology; Intermittent Claudication - therapy; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease - diagnostic imaging; Peripheral Arterial Disease - physiopathology; Peripheral Arterial Disease - therapy; Prospective Studies; Prosthesis Design; Recovery of Function; Recurrence; Retreatment; Risk Factors; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2016.02.051

This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA). Drug-eluting BVS has shown promise in coronary arteries. The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication. Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet. The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974).