Abbott says its bioabsorbable drug-eluting stent could become next major breakthrough in interventional treatment

14 October 2008

Mumbai: Abbott today said that two-year data from 30 patients in its ABSORB clinical trial showed hat 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.

According to Abbott, patients who received its 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. The company said these results confirmed its earlier positive one-year clinical results with its 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 on Wednesday, 15 October 2008.

Abbott says the 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 per cent decrease in plaque area (p=<0.001, n=17); 10.8 per cent 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.