WASHINGTON, Oct. 13 Abbott (NYSE: ABT) todayannounced two-year data from 30 patients in its ABSORB clinical trial,demonstrating that its bioabsorbable drug eluting stent successfully treatedcoronary artery disease and was absorbed into the walls of treated arterieswithin two years, leaving behind blood vessels that appeared to move andfunction similar to unstented arteries. Patients who received Abbott'sbioabsorbable drug eluting coronary stent and were followed out to two yearsexperienced no stent thrombosis out to two years and no new major adversecardiac events (MACE) between six months and two years. These resultsconfirmed earlier positive one-year clinical results with Abbott'sbioabsorbable drug eluting stent. The results were presented today at theCardiovascular Research Foundation's 20th annual Transcatheter CardiovascularTherapeutics (TCT) scientific symposium.
"Now you see it, now you don't -- for the first time, we have data inpatients showing that Abbott's bioabsorbable drug eluting stent does its jobtreating diseased coronary arteries and that it is absorbed by two years,"said John Ormiston, M.D., principal investigator in the ABSORB trial andmedical director at Mercy Angiography in Auckland, New Zealand. "Clinicalsafety and effectiveness were sustained at two years, and the previouslystented portion of arteries demonstrated the ability to expand and contract ina manner similar to a vessel that has never been stented. These are veryexciting results that represent a potential major breakthrough in the futuretreatment 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 coronaryblood vessels after the stent was absorbed -- something that is not possiblewith permanent metal-based stent implants.
Abbott also will present groundbreaking intravascular ultrasound (IVUS)and optical computed tomography (OCT) imaging data on its bioabsorbable drugeluting coronary stent platform this week at TCT in the "Best of CoronaryInterventions Abstracts" session at 9:20 a.m. Eastern time on Wednesday, Oct.15, 2008. IVUS data will reveal a decrease in plaque area in treated arteriescorresponding to a similar increase in blood flow area between six months andtwo years: 12.7 percent decrease in plaque area (p=<0.001, n=17); 10.8 percentincrease in luminal area (p=0.03, n=17). OCT imaging data will show absorptionof the stent into artery walls and that the blood vessel lining of arteriestreated with Abbott's bioabsorbable stent looks more uniform after two yearsthan it did immediately post-treatment.
"The imaging technology data from the ABSORB trial indicate that Abbott'sbioabsorbable stent has the potential to restore vascular integrity andendothelial function to treated vessels after two years," said ProfessorPatrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at theThoraxcentre, Erasmus University Hospital, Rotterdam, and co-principalinvestigator in the ABSORB trial. "With these ABSORB data, we have come fullcircle in interventional time, linking the past, when balloon angioplasty wasused without stents, to the future, when disappearing stents may become thenew standard of care for patients with coronary artery disease."
Abbott is the only company with long-term clinical data evaluating thesafety and performance of a fully bioabsorbable drug eluting coronary stentout to two years. Abbott's bioabsorbable everolimus eluting coronary stent ismade of polylactic acid, a proven biocompatible material that is commonly usedin medical implants such as dissolvable sutures. As with a metallic stent,Abbott's bioabsorbable stent is designed to restore blood flow by propping aclogged vessel open, and to provide support until the blood vessel heals.Unlike a metallic stent, however, a bioabsorbable stent is designed to beslowly metabolized by the body and completely absorbed over time.
"The early success of our bioabsorbable stent marks the dawn of thebeginning of a new era in the history of interventional medical devicetreatment," said John M. Capek, Ph.D., executive vice president, MedicalDevices, Abbott. "Today's data show that bioabsorbable stents have become morethan just a wish for patients -- they are now on their way to becoming aclinical reality."
Abbott will begin enrolling the next cohort of 80 patients into itsinternational ABSORB clinical trial in the first half of 2009.
ABSORB Clinical Trial Results
Two-year data from the first 30 patients enrolled in the ABSORB clinicaltrial demonstrated a low (3.6 percent, n=28) MACE rate, which was consistentwith results at one year (3.4 percent, n=29) and before six-months(3.3 percent, n=30). One patient had a minor heart attack due to lack of bloodsupply at six-months, another was electively lost to follow up at one year,and one patient died from a non-cardiac cause at two years. A zero percentstent thrombosis rate persisted for all patients across all time points in theABSORB trial. Potential restoration of unstented artery movement to coronaryblood vessels after the bioabsorbable stent was absorbed was revealed at twoyears with the drugs acetylcholine and nitroglycerin used in nine patients,showing vasodilation in the previously stented area, and methergine used inseven patients, showing vasoconstriction in the previously stented area.
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label) studydesigned to enroll up to 110 patients in Belgium, Denmark, France, NewZealand, Poland and the Netherlands. Key endpoints of the study includeassessments of safety -- MACE (defined as any event that resulted inre-treatment of the treated artery, heart attack or cardiac death) and stentthrombosis (blood clot formation) rates -- at 30, 180 and 270 days, withadditional annual follow-up for up to five years, as well as an assessment ofthe acute performance of the bioabsorbable drug eluting stent. Other keyendpoints of the study include successful deployment of the bioabsorbable drugeluting stent, follow-up measurements assessed by angiography, intravascularultrasound (IVUS), and state-of-the-art imaging modalities at 180 days and twoyears.
Everolimus, developed by Novartis Pharma AG, is a proliferation signalinhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on itsdrug eluting stents. Everolimus has been shown to inhibit in-stent neointimalgrowth in the coronary vessels following stent implantation, due to itsanti-proliferative properties.
For images of Abbott's bioabsorbable stent and other information, pleasevisit the company's online TCT newsroom athttp://www.abbottvascular.com/presskit.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leadingvascular care businesses. Abbott Vascular is uniquely focused on advancing thetreatment of vascular disease and improving patient care by combining thelatest medical device innovations with world-class pharmaceuticals, investingin research and development, and advancing medicine through training andeducation. Headquartered in Northern California, Abbott Vascular offers acomprehensive portfolio of vessel closure, endovascular and coronary products.
Abbott is a global, broad-based health care company devoted to thediscovery, development, manufacture and marketing of pharmaceuticals andmedical products, including nutritionals, devices and diagnostics. The companyemploys more than 68,000 people and markets its products in more than 130countries.
Abbott's news releases and other information are available on thecompany's Web site at http://www.abbott.com.