Abbott announced positive nine-month results from the first 45 patients enrolled in the second stage of the ABSORB trial. At nine months, Abbott's 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 (MACE) unchanged at 4.4 per cent and no reports of blood clots (thromboses). These results were presented during the Cardiovascular Research Foundation's 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC.
"I am impressed with how consistent the BVS data have been to date, as the nine-month data are compelling and supportive of earlier positive results," said John Ormiston, M.D., medical director at Mercy Hospital in Auckland, New Zealand, and co-principal investigator for the ABSORB trial. "In addition to the positive safety data we've seen to date, the late loss rate of 0.19 millimeters 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."
Abbott also presented six-month results for all 101 patients enrolled in the second stage of the ABSORB trial. In this complete patient population, the MACE rate remained consistent, with a nominal increase from 4.4 percent at six months in the first 45 patients to 5.0 percent at six months in all 101 patients. There were no reports of blood clots in any of the 101 patients.
"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," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial. "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."
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. The BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as resorbable sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to slowly metabolize and eventually be resorbed by the body. Since a permanent implant is not left behind, a vessel treated with a BVS may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. The potential to restore these naturally occurring vessel functions, or vascular restoration, is one of the features that makes Abbott's BVS revolutionary in the treatment of coronary artery disease.
The ABSORB trial is a prospective, non-randomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety – MACE and treated-site thrombosis rates – at 30 days; six, nine, 12 and 24 months; with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12, 18, 24 and 36 months.
The ABSORB EXTEND trial is a single-arm study that is currently enrolling patients at up to 100 centres in Europe, Asia Pacific, Canada and Latin America. The trial will enrol approximately 1,000 patients, including patients with more complex coronary artery disease.
Abbott's bioresorbable technology delivers everolimus, an anti-proliferative drug. Everolimus is developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit treated-site neointimal growth in the coronary vessels following vascular device implantations, due to its anti-proliferative properties.
Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.