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Coronary artery disease (CAD) is the leading cause of death for men and women in the United States. For patients who do not require open heart surgery to open blocked blood vessels, inserting metallic drug-eluting stents is standard therapy. Stony Brook specialists will compare the efficacy and safety of Absorb™, a drug-eluting bioresorbable vascular scaffold (BVS) manufactured by Abbott, to standard metallic drug-eluting stents in two groups of patients. Absorb will only be used in patients whose condition enables them to elect for the dissolvable stent. The Principal Investigator leading the trial at Stony Brook is Luis Gruberg, MD.
"This type of coronary stent that 'disappears' is the latest technology to treat vessel blockages," said Dr. Gruberg, Professor of Medicine, Division of Cardiovascular Medicine, and Director of Research, Interventional Cardiology, at Stony Brook University School of Medicine. "Unlike metallic stents that stay within the vessels permanently, this stent completely dissolves within about two years after implantation and may promote natural vessel motion to the treated tissue." The ABSORB III clinical trial will enroll approximately 2,250 patients at over 100 locations throughout the U.S. Although the Absorb BVS has been approved in Europe since 2011 and is currently being used across Europe and parts of Asia Pacific and Latin America, it is not yet cleared for use in the United States. The ABSORB III trial will provide the basis for an anticipated FDA approval. At Stony Brook, Dr. Gruberg expects to enroll 30 to 40 patients. Eligibility is based on non-emergency cases with simple blockages in the coronary arteries. Men or women of any age in need of stent implantation may be eligible. Dr. Gruberg said that the BVS technology and the device acting as a "temporary scaffold" to the vessel is designed to result in more vessel flexibility compared to vessels with permanent metallic stents. He explained that the potential end result is a dissolved stent with a vessel that has enhanced pulsation similar to a normal, unblocked blood vessel. To determine this endpoint, Dr. Gruberg will evaluate vasomotion, a measure of how much natural motion returns to the vessel in patients treated with Absorb once the new device dissolves into arterial tissue. A unique aspect of the BVS stent is that it is made of polylactide, a naturally dissolvable material derived from products like corn starch, which is commonly used in medical implants such as dissolving sutures. After the drug-eluting stent dissolves only two pairs of tiny metallic markers are left behind to enable a physician to identify where the device was implanted. Following is an animation, supplied by Abbott, depicting how the resorbable device works: Video not loaded
For more information about this clinical trial and enrollment at Stony Brook, please call the Stony Brook University Heart Institute Research Office at 631-444-3309 About Stony Brook University Heart Institute Source: Stony Brook University Heart Institute with additional reporting by Burt Cohen, September 22, 2013 |
