ESPRIT I Trial's 3-Year Results Reported for Abbott Vascular's Esprit Bioresorbable Vascular Scaffold

September 21, 2016—Michael R. Jaff, DO, presented data from the ESPRIT I trial during the third Late-Breaking Trials session at VIVA 16, the 14th annual Vascular InterVentional Advances meeting, which is sponsored by VIVA Physicians, Inc. and held September 18–22, 2016 at the Wynn Las Vegas in Las Vegas, Nevada.

The purpose of the ESPRIT I clinical investigation was to evaluate the safety and performance of the Esprit everolimus-eluting bioresorbable vascular scaffold (Abbott Vascular) in patients with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries. The trial was a prospective, single-arm, open-labeled, multicenter clinical investigation that enrolled 35 patients at seven clinical sites in Europe. Follow-up through 3 years has been completed in the study patients.

At VIVA 16, Dr. Jaff advised that clinical assessment and peak systolic velocity ratio assessment by duplex ultrasound were performed at 1, 6, and 12 months and at 2 and 3 years. Angiographic follow-up was performed at 12 months.

Thirty-five study scaffolds (6 X 58 mm) and one nonstudy stent were placed in 35 patients Rutherford Becker category 1 to 3 disease with lesion length of 35.5 mm and reference vessel diameter of 4.9 mm. Acute device success was 100%. Angiographic restenosis at 1 year was lower in smaller vessels, where scaffold size was matched appropriately to vessel diameter.

The 3-year results confirm earlier data demonstrating the safety and feasibility of treatment with the Esprit bioresorbable vascular scaffold for SFA and iliac lesions, with no new events occurring between 2 and 3 years, noted Dr. Jaff.