Indiana University School of Medicine is First in State to Test New Procedure for Cardiac Patients
INDIANAPOLIS--Indiana University School of Medicine cardiologists and radiation specialists will test an experimental treatment that could reduce the need for repeat balloon angioplasty and bypass procedures.
The new procedure, which is the first FDA-approved clinical trial of its kind, involves irradiating the interior of a cardiac artery immediately after physicians perform balloon angioplasty on the patient. IU is the only site in Indiana and one of only 23 in the nation testing the intracoronary radiation therapy procedure.
Angioplasty is performed in patients with coronary artery disease, which is the leading cause of death in the U.S. The disease affects more than 13 million people in the nation and, this year alone, an estimated 1.8 million patients will undergo procedures such as bypass surgery or balloon angioplasty to re-open their arteries.
In balloon angioplasty, physicians use a catheter to thread their way through the artery to the site of a blockage caused by the narrowing or stenosis of the artery. Then a balloon on the end of the catheter is inflated to open the blocked site.
In 30 percent to 50 percent of all patients treated with balloon angioplasty, the artery narrows again. This event is called restenosis.
"When a patient undergoes balloon angioplasty, the treatment may injure the artery walls causing scar tissue to grow as part of the healing process," explained Vincent Pompili, M.D., assistant professor of medicine, an investigator at the Krannert Institute of Cardiology and the principal investigator of the trial. "The scar tissue causes a re-narrowing or restenosis of the artery and a second balloon angioplasty may be needed."
Until now, the only treatment available to help prevent restenosis was placement of a stent, which is an expandable metal device that is permanently implanted to support the artery wall. However, even with stents, restenosis can occur in up to 20 percent of the patients, often leading to yet another angioplasty procedure. About 900,000 coronary interventions are preformed each year in the United States and about 180,000 of those are repeat angioplasty procedures.
With the intracoronary radiation therapy procedure, physicians use a catheter to insert a low dose of radiation inside the coronary artery at the site where the stenosis has been treated with angioplasty. Beta radiation is used to inhibit cell growth inside the artery.
The procedure takes less than 10 minutes and patients are exposed to less than 1 percent of the radiation used in a normal x-ray, said Robert Timmerman, M.D., assistant professor of radiation oncology and co-investigator on the trial. In earlier studies, intracoronary radiation reduced restenosis by 70 percent.
"We have been aware for a long time that radiation may inhibit the formation of certain types of scar tissue growth," said Dr. Timmerman. "Only recently, however, has it been technically feasible to effectively deliver radiation within a small artery. These new devices allow fairly high doses of beta or electron radiation to be delivered to the artery wall with very little penetration beyond."
A total of 1,100 patients will be enrolled in the multi-center trial. This is a Phase III placebo-controlled trial sponsored by Novoste Corp., makers of the Beta-Cath system which delivers the dose of beta radiation inside the artery.
For additional information or an appointment, call the Krannert Institute of Cardiology at 317-630-7261.
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