Abbott Announces Positive Six-Month Results From the World's FirstClinical Trial of a Fully Bioabsorbable Drug-Eluting Coronary StentAbbott's Bioabsorbable Stent Technology Holds Promise as Future-Generation Treatment Option for Physicians Treating Patients with Coronary Artery Disease
ABBOTT PARK, Ill., March 24, 2007 /PRNewswire-FirstCall/ -- Abbott today announced positive results from ABSORB, the world's 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, presented at the 56th Annual of Cardiology Scientific Session in New Orleans, 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, M.D., Ph.D., 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.
"Based on these encouraging safety results, Abbott will continue to advance this technology by enrolling the next cohort of patients in the ABSORB study in Europe and New Zealand," said John M. Capek, Ph.D., 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."
About the ABSORB Trial
The ABSORB trial is 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 of the study include assessments of safety -- MACE and stent thrombosis (blood clot formation) 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, IVUS, 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. The co-principal investigator of the study is John Ormiston, M.D., of Mercy Hospital in Auckland, New Zealand.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety and effectiveness in treating patients with vascular disease.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Posted: March 2007