A fully bioabsorbable drug-eluting stent platform shows promise based on preliminary results from a first-of-its-kind clinical trial, according to a presentation at the scientific session of the American College of Cardiology.

The six- month results from the first 30 patients in the trial demonstrated no stent thrombosis and a 3.3-percent hierarchical rate of ischemia-driven major adverse cardiac events such as myocardial infarction or repeat intervention.

"The encouraging results from the first 30 patients of ABSORB suggest that drug-eluting bioabsorbable stent technologies may be a promising future therapy option for physicians treating patients with heart disease," said Patrick W. Serruys, MD, PhD, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator of the study. "A drug eluting stent that would eventually disappear after restoring blood flow is an exciting concept that we look forward to further exploring."

The single adverse event was a non-Q-wave myocardial infarction. The same patient underwent a repeat intervention at the site of the original procedure, resulting in an overall target lesion revascularization rate of 3.3 percent.

The trial results confirmed that the treatment effect of everolimus in the bioabsorbable stent is similar to that observed in studies of metallic drug-eluting stents, with everolimus actively inhibiting tissue growth into the artery. The rate of device success (successful placement of the bioabsorbable stent at the site of the lesion) was 93.5 percent.

The bioabsorbable stent is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures.

The ABSORB trial was a prospective, non-randomized, open-label study designed to enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and the Netherlands. Key endpoints include assessments of safety - major adverse cardiovascular event rates and stent thrombosis rates -- at 30, 180 and 270 days, with an annual follow-up for up to five years, and successful deployment of the bioabsorbable drug-eluting stent.

Other key endpoints of the study include follow-up measurements assessed by angiography, intravascular ultrasound, and state-of-the-art imaging modalities at 180 days and two years, as well as a new noninvasive technique in a subset of patients at 18 months.