Abbott releases results from bioabsorbable drug-eluting stent trial

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Abbott Vascular released positive results from ABSORB, the first clinical trial evaluating the overall safety and performance of a fully bioabsorbable drug-eluting stent platform for the treatment of coronary artery disease. Six-month results from the first 30 patients in the trial were presented at ACC 2007 in New Orleans. The trial demonstrated no stent thrombosis and a low (3.3 percent) hierarchical rate of ischemia-driven major adverse cardiac events (MACE), such as heart attack 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, who is 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 MACE event reported was a non-Q-wave myocardial infarction. The same patient underwent a repeat intervention that occurred 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 Abbott's 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.
Abbott's everolimus-eluting bioabsorbable stent is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. As with a metallic stent, the bioabsorbable stent is designed to restore blood flow by propping the vessel open, providing support until the blood vessel heals. Unlike a metallic stent, a bioabsorbable stent is designed to be slowly metabolized by the body and completely absorbed over time.
Abbott plan to continue advancing this technology by enrolling the next cohort of patients in the ABSORB study in Europe and New Zealand, said John M. Capek, PhD, senior vice president, Abbott Vascular. "The next phase of the ABSORB study will utilize a next-generation bioabsorbable everolimus-eluting stent that incorporates several advancements designed to improve strength and deliverability."