ESPRIT 1: Bioresorbable vascular scaffold effective at 6 months

A bioresorbable drug-eluting scaffold for treatment of symptomatic atherosclerotic disease of the superficial femoral artery or iliac arteries was effective at 6 months, according to a study presented at the 26th annual International Symposium on Endovascular Therapy.

The scaffold (Esprit BVS, Abbott Vascular) is designed to dissolve into the bloodstream in 18 months to 2 years.

Johannes Lammer, MD, of the Medical University of Vienna, Austria, and colleagues are conducting the prospective, single-arm, multicenter ESPRIT 1 study to determine the clinical effectiveness of the scaffold in 35 patients (mean age, 65 years; 77% men) with single de novo lesions of the superficial femoral artery (n=31) or external iliac arteries (n=4). Patients had lesion lengths ≤50 mm and vessel diameters ≥5.5 mm to ≤6.5 mm.

At 6 months, in the 34 patients not lost to follow-up, the researchers observed no deaths, amputations, bypass surgery of the treated limb, scaffold thrombosis, target lesion revascularization, target vessel revascularization or target extremity revascularization. Angiographic and duplex ultrasound results showed widely patent arteries after the procedure, with no indicators of acute scaffold recoil. In-stent diameter restenosis was reduced from 80% to 13.1% after the procedure. Lammer also reported 100% acute procedural success.

Prior to stenting, 91% of patients had moderate to severe pain when walking and none reported being free of pain. At 6 months, 85% of patients had no pain while walking and 3% had moderate pain, according to a press release. The researchers also observed substantial improvement in functional status; severe claudicants (Rutherford category 3) dropped from 57% at baseline to 0% at 6 months.

“The 6-month results are very promising — we’re seeing zero restenosis in the first patients to receive the [scaffold] on the peripheral arteries,” Lammer stated in the release. “The [scaffold] combines the best of proven treatments while avoiding some of the problems. It opens arteries and prevents restenosis, then resorbs into the bloodstream so there are no stent breaks, no prolonged irritation or delayed in-stent restenosis and no interference with [MRI] or surgery.”

For more information:

Lammer J. Session VIII: Treating the SFA: Are we making progress? Presented at: ISET; Jan. 18-22, 2014; Miami Beach, Fla.

Disclosure: The study was funded by Abbott Vascular.