New Data Shows Abbott's Bioabsorbable Drug Eluting Stent Is Absorbed Within Two Years - Leaving Behind Functioning Blood Vessels
SummaryData Indicate Bioabsorbable Stent Platform Has Potential to Become the Next Major Breakthrough in Interventional Treatment
Washington — Abbott (NYSE: ABT) today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries. Patients who received Abbott's bioabsorbable drug eluting coronary stent and were followed out to two years experienced no stent thrombosis out to two years and no new major adverse cardiac events (MACE) between six months and two years. These results confirmed earlier positive one-year clinical results with Abbott's bioabsorbable drug eluting stent. The results were presented today at the Cardiovascular Research Foundation's 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
"Now you see it, now you don't – for the first time, we have data in patients showing that Abbott's bioabsorbable drug eluting stent does its job treating diseased coronary arteries and that it is absorbed by two years," said John Ormiston, M.D., principal investigator in the ABSORB trial and medical director at Mercy Angiography in Auckland, New Zealand."Clinical safety and effectiveness were sustained at two years, and the previously stented portion of arteries demonstrated the ability to expand and contract in a manner similar to a vessel that has never been stented. These are very exciting results that represent a potential major breakthrough in the future treatment of patients with coronary artery disease."
Trends were observed in data from tests of artery movement and function, demonstrating a potential restoration of unstented artery movement to coronary blood vessels after the stent was absorbed – something that is not possible with permanent metal-based stent implants.
Abbott also will present groundbreaking intravascular ultrasound (IVUS) and optical computed tomography (OCT) imaging data on its bioabsorbable drug eluting coronary stent platform this week at TCT in the "Best of Coronary Interventions Abstracts" session at 9:20 a.m. Eastern time on Wednesday, October 15, 2008. IVUS data will reveal a decrease in plaque area in treated arteries corresponding to a similar increase in blood flow area between six months and two years: 12.7 percent decrease in plaque area (p=<0.001, n=17); 10.8 percent increase in luminal area (p=0.03, n=17). OCT imaging data will show absorption of the stent into artery walls and that the blood vessel lining of arteries treated with Abbott's bioabsorbable stent looks more uniform after two years than it did immediately post-treatment.
"The imaging technology data from the ABSORB trial indicate that Abbott's bioabsorbable stent has the potential to restore vascular integrity and endothelial function to treated vessels after two years," said Professor Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB trial. "With these ABSORB data, we have come full circle in interventional time, linking the past, when balloon angioplasty was used without stents, to the future, when disappearing stents may become the new standard of care for patients with coronary artery disease."
Abbott is the only company with long-term clinical data evaluating the safety and performance of a fully bioabsorbable drug eluting coronary stent out to two years. Abbott’s bioabsorbable everolimus eluting coronary 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, Abbott’s bioabsorbable stent is designed to restore blood flow by propping a clogged vessel open, and to provide support until the blood vessel heals. Unlike a metallic stent, however, a bioabsorbable stent is designed to be slowly metabolized by the body and completely absorbed over time.
"The early success of our bioabsorbable stent marks the dawn of the beginning of a new era in the history of interventional medical device treatment," said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Today’s data show that bioabsorbable stents have become more than just a wish for patients – they are now on their way to becoming a clinical reality."
Abbott will begin enrolling the next cohort of 80 patients into its international ABSORB clinical trial in the first half of 2009.