More than 300,000 angioplasty procedures are performed in the United States every year, but in almost 40percent of those cases tissue grows back in the blood vessel and additional blockages develop - all because of the trauma associated with inserting the angioplasty catheter itself. However, Researchers at Penn State's College of Medicine have developed a procedure that virtually eliminates that new tissue growth. The team found that coating the balloon angioplasty catheters with ceramide reduces the risk of subsequent blockages by greater than 90% in animal studies.
The Penn State team of scientists, led by principal investigator Mark Kester, Ph.D. associate professor of pharmacology, has worked for the past five years to solve this significant medical challenge. Kester and his colleagues will publish the results of their research in a new paper titled, "Ceramide-coated Balloon Catheters Limit Neointimal Hyperplasia Following Stretch Injury in Carotid Arteries", appearing in the August 18, 2000 issue of the journal Circulation Research.
Dr. Kester explained, "While angioplasty has literally been a lifesaver for millions of patients, the very act of inserting a catheter causes arterial damage. The damaged artery responds to this trauma with rapid vascular smooth muscle cell growth at the site of the injury (known as restenosis), resulting in a blockage and a significant reduction in blood flow. Our research has revealed that applying an analogue of a naturally occurring membrane component called ceramide to the balloon surface of angioplasty catheters inhibits the growth of those smooth muscle cells so that blockages don't develop."
Kester and his team found that when the balloon angioplasty catheters are coated with a cell-permeable ceramide, the growth-inhibiting drug is delivered to the precise area injured by the inflation of the balloon catheter. Through both cell culture system and animal trials, the ceramide was found to be a safe and effective therapy, preventing vascular smooth muscle cell growth and resultant arterial obstruction. Additional testing is planned with clinical trials anticipated in two years. Kester has filed a provisional patent for his work.
While the majority of patients who would benefit the most from this breakthrough are those who receive coronary angioplasty or stents, Kester believes additional uses will follow. "Patients who suffer from kidney diseases and need dialysis must be connected to dialysis machines through functional arteries and veins," Kester noted. "The access ports often become clogged or restricted because of restenosis. We think the ceramide treatment could help those patients as well."
The Penn State team led by Dr. Kester includes Peter Waybill, M.D., Marc Kozak, M.D., Ronald Wilson, D.V.M., Steven Levison, Ph.D., Lakshman Sandirasegarane, Ph.D., Jong Yun, Ph.D., Nicole Bourbon, B.S., Raymond Rothstein, B.S. and Roger Charles, B.S. The research was sponsored by the W.W. Smith Charitable Trust in Newtown Square, Pennsylvania and by the National Institutes of Health.
Journal
Circulation Research