Positive nine-month results from the first 45 patients enrolled in the second stage of the ABSORB trial were presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC, USA.
At nine months, the Bioresorbable Vascular Scaffold (BVS) demonstrated strong results that remained consistent with the six-month data from the same 45-patient group, with the rate of major adverse cardiac events unchanged at 4.4% and no reports of thromboses. The results were presented by John Ormiston, Mercy Hospital, Auckland, New Zealand, and co-principal investigator for the ABSORB trial.
Six-month results for all 101 patients enrolled in the second stage of the ABSORB trial were also presented. In the complete patient population, the major adverse cardiac events rate remained consistent, with a nominal increase from 4.4% at six months in the first 45 patients to 5.0% at six months in all 101 patients. There were no reports of thromboses in any of the 101 patients.
“In addition to the positive safety data we’ve seen to date, the late loss rate of 0.19mm reported at six months is comparable to a metallic drug eluting stent, and may address a limitation of metal stents by not leaving metal in the artery. This technology is truly a step forward for the field of interventional cardiology, and I am excited about the prospect of treating patients with this revolutionary product,” said Ormiston.
The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. The scaffold is then slowly metabolised and resorbed by the body. Since a permanent implant is not left behind, a vessel treated with a bioresorbable vascular scaffold may ultimately have the ability to move, flex and pulsate similar to an untreated vessel.
“We are pleased with the progress of ABSORB and the encouraging data we continue to see from the trial in the entire cohort of more than 100 patients. The findings to date show that the device appears to effectively treat coronary artery disease with the possibility of restoring natural vessel function in a way that is not possible with permanent implants,” said Patrick W Serruys, Thoraxcentre, principal investigator for the ABSORB trial, Erasmus University Hospital, Rotterdam, The Netherlands.
Abbott’s BVS is under investigation in two clinical studies, ABSORB and ABSORB EXTEND, and is currently not available for sale anywhere in the world.