November 1997

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Kathi Ovnic, 404/727-9371 -

ORLANDO -- Coronary arteries remain open six months after mild irradiation in 90 percent of postangioplasty patients evaluated in the Beta Radiation for Restenosis Trial (BERT-1), reports Emory University's Spencer B. King III, M.D., principal investigator of BERT-1, today at the 70th American Heart Association Scientific Sessions.

These findings suggest radiation treatment blocks restenosis -- the process by which coronary arteries widened by balloon angioplasty eventually renarrow.

BERT-1 is the first human trial to test the use of low doses of locally-delivered beta radiation for preventing restenosis that occurs in about one-third of patients who undergo angioplasty. A phase III clinical trial based on BERT-1 preliminary data is now evaluating the technique in 1,100 patients at 26 medical centers in North America and Europe.

During the study, specially fitted catheters delivered minute amounts of beta radiation (90Sr/Y) to angioplasty sites in the coronary arteries of 35 patients. The researchers measured the diameter of vessel openings before angioplasty, just after angioplasty and at six months' followup. Subjects' vessels were, on average, 73 percent closed before angioplasty, 25 percent just after angioplasty and 25 percent at the six-month followup.

The increase noted in the diameter of the vessel's opening (lumen) several months after angioplasty when compared to the opening just after angioplasty is referred to as "late loss." The team found that radiation reduced the late loss and late loss index by 85-90 percent.

"Using this system, intracoronary beta radiation was feasible without disrupting the normal cath (cardiac catheterization) lab routine or producing complications," report Dr. King and his colleagues. "As illustrated, the usual late lumen loss was eliminated in most patients."

BACKGROUND During angioplasty, a balloon-tipped catheter is threaded through arteries to sites within those arteries that nourish the heart with oxygen-rich blood. As the balloon expands, it pushes plaque against vessel walls and frees up blood flow. Unfortunately, that same lifesaving procedure (as well as the use of tiny metal stents to prop open vessels) triggers an inflammatory response in about one-third of patients, putting them at risk for restenosis and further cardiac complications.

About 500,000 coronary angioplasties are performed domestically each year and another 500,000 are performed annually outside the United States; hence, about 300,000 persons each year are at risk for restenosis after angioplasty. In the United States, repeat angioplasties cost in the billions of dollars.

Dr. King directs the Gruentzig Cardiovascular Disease Research Center and is professor of Medicine (Cardiology) at the Emory University School of Medicine. Other authors of the current study include David O. Williams and Prakash Chougule of Rhode Island Hospital, Raoul Bonan of the Montreal Heart Institute, and Larry Klein, Ron Waxman, Keith A. Robinson, Kris Anderberg, Judy Scruby and Ian R. Crocker, all of the Emory University School of Medicine.

BERT-1 was funded by the National Institutes of Health.


Intracoronary Beta Radiation Inhibits Late Lumen Loss

Following Balloon Angioplasty: Results of the BERT-1 Trial (Abstract 1211)

Oral presentation: 3:45 p.m., Nov. 10, 1997 (Auditorium)

Spencer B. King III, Emory University;

David O. Williams, Prakash Chougule, Rhode Island Hospital, Raoul Bonan, Montreal Heart Institute, and Larry Klein, Ron Waxman, Keith A. Robinson, Kris Anderberg, Judy Scruby, and Ian R. Crocker, Emory University


(Beta Radiation for Restenosis Trial)

Emory has been a leader in early animal studies of radiation for restenosis, and early human studies testing efficacy of radiation for preventing restenosis after angioplasty in patients with peripheral artery disease or kidney disease.

1) EmoryÍs Spencer King, M.D., approached Novoste Corp. about developing the beta radiation system. Novoste obtained exclusive rights from Emory to use the system in August 1996.

2) Dr. King, who is principal investigator of Phase I of B.E.R.T. -- the first FDA approved trial testing beta radiation for restenosis after angioplasty -- presented results at the 1996 American Heart AssociationÍs Scientific Sessions. He is presenting six-month follow-up data at the 1997 Scientific Sessions.

3) Based on the findings of B.E.R.T.-1, the National Institutes of Health has funded a Phase II study which is beginning (in the fall of 1997) to recruit 1,110 patients at 26 medical centers in the United States, Canada and Europe. Emory is one study site. Principal investigator of Phase II is Richard Kuntz, M.D., of Beth Israel Hospital, Boston.

4) First patient in Atlanta to receive radiation treatment for Phase II of B.E.R.T. underwent procedure led by EmoryÍs John Douglas, M.D., early in September, 1997.

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Copyright ©Emory University, 1997. All Rights Reserved.
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