Six-month results from the prospective, single-arm, multicentre, European ESPRIT I trial being presented at the 26th annual International Symposium on Endovascular Therapy (ISET, 18–22 January, Miami, USA) suggest that the Esprit drug-eluting bioresorbable vascular scaffold (Abbott Vascular) appears to be effective in treating iliac and femoral lesions.
The ESPRIT I set out to evaluate the safety and performance of the Esprit Bioresorbable Vascular Scaffold in patients with symptomatic atherosclerotic disease of the superficial femoral or iliac arteries.
Johannes Lammer, professor of Radiology and director, Division of Cardiovascular and Interventional Radiology, Medical University of Vienna, Austria, speaking on behalf of the trial investigators, reported a 100% acute procedural success. “Angiographic and duplex ultrasound results show widely patent arteries after the procedure, with no indicators of acute scaffold recoil. There were no clinical endpoint events, target lesion revascularisation or scaffold thrombosis observed out to six months. There was a substantial improvement in functional status of patients; severe claudicants (Rutherford category 3) dropped from 57% at baseline to 0% at six months,” he said.
“The six-month results are very promising. The bioresorbable vascular scaffold combines the best of proven treatments while avoiding some of the problems. It opens arteries and prevents restenosis, then resorbs into the blood stream so there are no stent breaks, no prolonged irritation or delayed in-stent restenosis and no interference with magnetic resonance imaging or surgery,” Lammer added.
The Esprit bioresorbable vascular scaffold looks and works like a stent and is designed for use in the treatment of lesions in the superficial femoral artery and iliac arteries. It is made of polylactide that naturally resorbs and fully metabolises. The everolimus drug-coating is designed to prevent restenosis. The BVS is called a scaffold rather than a stent because it is a temporary structure that naturally dissolves into the blood stream within 18 months to two years, rather than a permanent implant.
In the study, 35 patients were treated for blockages averaging about 3.5cm in length; 22.9% were total occlusions. Four patients had blockages in the pelvic iliac arteries (11.4%) and 31 (88.6%) in the superficial femoral artery. Six months after treatment, all of the arteries in the 34 patients who were followed remained open, with the narrowing reduced from an average of 80% prior to treatment to 13% after treatment. Prior to treatment, 32 patients (91%) had moderate to severe pain while walking, and no patients were pain-free. Six months after treatment, 29 patients (85%) had no pain while walking, and only one (3%) had moderate pain.