12 months on: REVA presents stent trial follow-up results

REVA Medical (ASX:RVA) has announced some positive 12-month, follow-up results from a safety and efficacy trial of its drug-eluting bioresorbable coronary scaffold ReZolve.

The results, presented at the European Course of Revascularization in Paris last week, represent the first 12-month data from a clinical trial which concluded in July 2012.

The eight patients who have completed 12-month angiographic follow-up have demonstrated a mean in-stent late lumen loss - or the change in the minimum diameter of the interior of an artery - of just 0.20 mm.

By comparison, permanent drug-eluting stents usually exhibit late loss values in the range of 0.20 to 0.40 mm.

Principal investigator Dr Alexandre Abizaid, director of invasive cardiology at Brazil’s Instituto Dante Pazzanese de Cardiologia, said the results so far have been encouraging.

“The 12-month late loss demonstrated to date with the ReZolve scaffold is well within the range of safety and performance of drug-eluting metal stents and bioresorbable scaffolds that are used today,” he said.

A total of 22 patients were enrolled in the trial. Since completing an analysis of a six-month follow-up, two patients have had to be treated for focal in-stent restenosis - or renarrowing of the artery at the implant site - and one patient died of unknown causes.

“We learned a great deal from this initial trial,” REVA Chairman and CEO Bob Stockman said.

“The adverse clinical events relating to restenosis occurred in patients that were enrolled in the early stages of the study; the learning from these early cases led to improved lesion preparation techniques for optimal bioresorbable scaffold placement, as well as design enhancements in REVA’s commercial product, ReZolve2.”

ReZolve2 is a sheathless version of the ReZolve scaffold. REVA Medical began enrolling patients for a clinical trial of the improved design in March and aims to have enrolled 125 patients by September.