At the ongoing Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC, Abbott has just presented new results from two-year data from 30 patients in its ABSORB clinical trial. The company says 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.”
More details from Abbott’s press statement:
ABSORB Clinical Trial Results
Two-year data from the first 30 patients enrolled in the ABSORB clinical trial demonstrated a low (3.6 percent, n=28) MACE rate, which was consistent with 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 blood supply 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 percent stent thrombosis rate persisted for all patients across all time points in the ABSORB trial. Potential restoration of unstented artery movement to coronary blood vessels after the bioabsorbable stent was absorbed was revealed at two years with the drugs acetylcholine and nitroglycerin used in nine patients, showing vasodilation in the previously stented area, and methergine used in seven patients, showing vasoconstriction in the previously stented area.
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 110 patients in Belgium, Denmark, France, New Zealand, Poland and the Netherlands. Key endpoints of the study include assessments of safety – MACE (defined as any event that resulted in re-treatment of the treated artery, heart attack or cardiac death) and stent thrombosis (blood clot formation) rates – at 30, 180 and 270 days, with additional annual follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug eluting stent. Other key endpoints of the study include successful deployment of the bioabsorbable drug eluting stent, follow-up measurements assessed by angiography, intravascular ultrasound (IVUS), and state-of-the-art imaging modalities at 180 days and two years.
The company has also released the following video that takes a look at the stent technology:
Flashbacks: Bioabsorbable Stents: So Far So Good ; Evaluation of Bioabsorbable Drug Eluting Coronary Stent Underway; Dissolvable Heart Stents