Enrolment completed in DIRECT II study of rapamycin-eluting stents with biodegradable polymer


Svelte Medical Systems has announced that the final patient in the DIRECT II (Direct implantation of rapamycin-eluting stents with bioabsorbable drug carrier technology) study has been completed. DIRECT II is a prospective, randomised study that compared the safety and efficacy of Svelte’s drug-eluting coronary stent integrated delivery system (IDS) with the Resolute Integrity drug-eluting stent (Medtronic) in 159 patients at 19 investigative sites.

According to a company press release, the study builds on the positive results of the DIRECT I first-in-man study, which evaluated the Svelte drug-eluting coronary stent IDS in 30 patients in New Zealand. The Svelte system met all study endpoints in DIRECT I while demonstrating in-stent neointimal volume obstruction of 2.7% at six months, a one-third to one-half reduction in volumetric obstruction observed in similar studies with market-leading drug-eluting stents. Clinical outcomes reflected the strong angiographic findings, with 0% clinically driven major adverse cardiovascular events (MACE) reported through 18-months.

Primary endpoints of the DIRECT II study were target vessel failure and in-stent late loss. All patients are scheduled to receive six-month clinical and angiographic follow-up, with clinical follow-up continued through five years. A subset of patients will receive optical coherence tomography (OCT) imaging at six-months.

“We are pleased to have completed this rigorous evaluation of the Svelte drug-eluting stent IDS following the strong and sustained outcomes of the DIRECT I study,” said Stefan Verheye, co-director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp. “As continued emphasis is placed on downsizing access sites and improving procedural efficiencies as well as clinical outcomes, this system presents an important option to interventional cardiologists.”