NEW YORK, NY – SEPTEMBER 28, 2015 – Noteworthy data will be presented at Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium next month on several trials examining the use of cardiovascular stents (or “scaffolds”) that are absorbed back into the body over time.
“It really is a thrilling new technology and development for the stent field,” said Juan F. Granada, MD, Executive Director and Chief Innovation Officer of the CRF Skirball Center for Innovation and Co-Director of the TCT Conference. “Developed with materials that naturally resorb into the artery following implantation, bioresorbable stents give us an opportunity to treat the lesion and avoid the potential risks that exist by having the stent in the body for an extended period of time.”
The first bare-metal stents were very effective, but presented a risk of restenosis, or recurrence of the blockage. Drug-eluting stents then reduced restenosis, but with an increased risk of stent thrombosis occurring over time, a complication thought to be related to the potential interference of the permanently implanted stent with normal vessel healing. Over the last 15 years, significant refinements in stent design have drastically reduced these complications and now drug-eluting stents are considered the standard of care for many patients currently undergoing percutaneous coronary interventions.
Data on several late-breaking clinical trials will be presented at TCT:
- ABSORB III – A 2,000 patient randomized trial of the everolimus-eluting bioresorbable vascular scaffold (BVS). As the pivotal trial for the device, it will be reviewed by the FDA as it considers whether or not to approve this device. The trial measures the safety and efficacy of this scaffold compared to a current generation metallic drug-eluting stent (DES) at one year.
- Data will also be presented from a trial called ABSORB China, which tested the technology in that country.
- BIOSOLVE II examines the safety and efficacy of a different sirolimus-eluting bioresorbable metallic scaffold at six months. This is of particular importance as bioresorbable metals promise to maintain some of the biomechanical properties shown by their non-resorbable counterparts.
“There is a great deal of excitement regarding the results of these studies that are being presented at TCT. It has been a while since there was this much enthusiasm in the field of coronary intervention, and these stents have the potential to add significantly to our armamentarium for treating patients with coronary artery disease in a minimally invasive approach,” said Ajay J. Kirtane, MD, SM, Co-Director of TCT. He is also Director of Cardiac Catheterization Laboratories and Chief Academic Officer of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.