Bioresorbable drug-eluting scaffolding appears to be safe and effective in patients with iliac and femoral artery lesions, based on six-month results in the first-in-man ESPRIT trial presented Jan. 22 at the International Symposium on Endovascular Therapy in Miami Beach, Fla.
While promising, the findings are based on a single-arm study with a small number of uncomplicated patients and a short follow-up, said principal investigator Johannes Lammer, MD, director of the cardiovascular and interventional radiology division at Medical University in Vienna in Austria. “These were selected patients with very short and very simple lesions,” he told Cardiovascular Business. “Usually [in practice] we have patients who either have multiple lesions or who have longer lesions. It was a selected group of patients with less severe disease.”
ESPRIT was designed to assess the safety and performance of Abbott Vascular’s Esprit bioresorbable vascular scaffolding. Researchers from Belgium, Germany, France and Austria enrolled 35 patients with symptomatic atherosclerotic disease of the superficial femoral or iliac arteries who were treated for a single, de novo lesion with the Esprit device.
Lesion lengths were less than 50 mm and vessel diameter was between 5.5 mm and 6.5 mm. Claudication ranged from mild (Rutherford Classification 1, 8.6 percent of patients at baseline) to severe (Rutherford Classification 3, 57 percent at baseline).
Lammer reported 100 percent procedural success in this group. In-segment diameter stenosis decreased from 80 percent to 13.1 percent. At six months, there were no deaths, amputations of the treated limbs, scaffold thrombosis or target lesion or target vessel revascularizations. One patient was lost to follow-up.
None of the patients had severe claudication at six months and 67.7 percent of the cohort had no claudication at six months.
Lammer reported no indications of scaffold recoil as well, which had been a limitation previously.
“The very early bioresorbable scaffolds did not have enough radial stiffness, so if they were used in fibrotic or calcified lesions, then they could not open the artery sufficiently,” he explained. “Therefore the recoil is of high interest. These devices now have sufficiently high radial force so there was only minimal to zero recoil.”
The study is funded by Abbott Vascular and will extend over a three-year follow-up.