Radioactive Burst Rx to Keep Diseased Arteries Open

NEW YORK - January 24, 2001 - Experts at the U.S. Food and Drug Administration (FDA) caution that much more testing is needed to make sure that the benefits of a new radiation treatment outweigh the risks of the procedure, which may include blood clots and possibly an increased risk of later heart attack. The two studies are published in the January 25th issue of The New England Journal of Medicine.

European researchers are claiming that a dose of radiation can help keep heart arteries wide and clear after artery-clearing angioplasty. In one 6-month study conducted in Europe, 181 patients received various doses of a type of radiation, known as beta-radiation, in combination with angioplasty, either with or without stents. This type of procedure could be done in America without FDA approval.

About 30% to 40% of heart disease patients who undergo angioplasty end up with restenosis--a reclosure of the clogged artery. While stents can help prop the artery open, restenosis is still a risk. Usually, the re-closure is due to the overgrowth of new cells in the artery, which can be triggered by the angioplasty, a procedure in which a balloon-tipped catheter is used to squash fatty plaque against artery walls.

In patients without stents, the rate of restenosis was just 4% in patients who received the highest dose of radiation compared with 28% in those who had the lowest dose. A closer look showed that arteries actually widened in 74% of these patients with the highest dose, according to the report. The radiation dose also lowered the restenosis rate in patients with stents from 29% to 15%.

In a second study, investigators also found that radiation therapy can keep arteries from re-narrowing after angioplasty, but the treatment appeared to lead to some troubling complications in some patients with stents.

About 5% of patients in the radiation group experienced blood clots late in the study, compared with less than 1% of patients in the placebo group. This rise in blood clots was linked to an increased rate of heart attacks, which was more than twice as high in radiation-treated patients.

The problem only occurred in patients who received a new stent at the time of angioplasty and who had not had a complete course of blood-thinning drugs. So it is possible that limiting the use of new stents and the use of blood-thinning therapy may prevent the complications, according to Leon's team. However, the blood-thinning therapy may significantly increase the risk of death in a certain number of patients because blood-thinning drugs like Coumadin can cause life-threatening bleeding.

The study was funded by Cordis, the New Jersey-based manufacturer of the technology. Several of the researchers have served as consultants or received funding from companies involved in the development of radiotherapy.

“The FDA is in agreement...that we lack sufficient information to define the ultimate role of irradiation in the treatment of coronary disease,'' write Dr. Wolf Sapirstein, Dr. Bram Zuckerman and James Dillard.

SOURCE: The New England Journal of Medicine 2001;344:243-256, 295-299.

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