BETH ISRAEL LAUNCHES PILOT STUDY USING
RADIATION THERAPY IN CORONARY PROCEDURES
New York, NY -- Beth Israel Medical Center became the first hospital in New York to launch a nationwide protocol
study that could have a major impact on one of the nation's leading public health problems: recurrence of arterial
blockages in patients who have undergone angioplasties and stent implantation procedures.
Physicians from Beth Israel's invasive cardiology division are working with colleagues from the hospital's Department
of Radiation Oncology to wed their two disciplines to help reduce restenosis, the medical term used to describe
what happens when an angioplasty or similar procedure fails to permanently open a blocked or clogged artery. The
procedure under review, coronary brachytherapy, involves introducing a controlled dose of radiation directly into
the artery following the angiographic procedure.
The pilot procedure is being performed on two study groups: patients who are at risk for developing restenosis
following angioplasty, and patients developing restenosis following angioplasty and stenting, a procedure through
which a small metal tube is inserted directly in the artery for support. The American Heart Association estimates
that more than 600,000 angioplasties are performed annually in the United States, of which 30 to 50 percent result
in restenosis within the first six months. With stenting, the rate of restenosis is reduced by approximately one-third,
still leaving a 15-20 percent of stent patients requiring a second procedure.
During coronary brachytherapy, the cardiologist first performs the traditional angiographic procedure in which
a catheter is inserted into the patient's leg artery and steered through the body to the narrowed artery. The blockage
is then opened, either by inflating the balloon catheter or scraping away the plaque build-up in the artery. The
radiation oncologist then inserts another catheter into the same artery, which allows for a moderate dose of very
localized, ionizing radiation. The study will conclude whether the radiation helps reduce the proliferation of
arterial lining cells that occurs following angioplasties, thus decreasing the scar tissue that may form in the
artery in response to the balloon trauma. This is believed to be the primary cause of restenosis.
Beth Israel physicians involved in the study are optimistic about the results. "For quite some time, we have
been involved in the development of the prototype technology used in this study," said Louis B. Harrison,
M.D., chairman of the department of radiation oncology. "We believe that this procedure can accurately irradiate
the affected areas of the artery and, hopefully, improve the outcomes of the patients involved in this study."
The cardiologists on the study team also pointed to the significant impact the study could have on a very costly
public health problem. "If this study can prove that a major reduction in restenosis is possible, the national
number of repeat interventional procedures could be reduced significantly," said James Wilentz, M.D., director
of interventional cardiology. He also pointed out that while coronary brachytherapy takes a bit longer than the
traditional angioplasty procedures, it does not lengthen the patient's hospital stay, nor does it involve any additional
post-operative care.
Warren Sherman, M.D., director of the cardiac catheterization laboratory, said that Beth Israel recently renovated
and expanded its angiography suite to accommodate coronary brachytherapy, knowing that the introduction of this
form of treatment was imminent. "This is an exceptionally promising form of therapy to prevent restenosis,
" he said. ""It is, however, experimental and, as such, must be put to the test. By virtue of the
strengths of both Dr. Harrison's team and our cardiology group, we are uniquely positioned to conduct this research."
Juliana Pisch, M.D., the other radiation oncologist involved in the study, also pointed out that advanced imaging
technology, such as intravascular ultrasound, has made it easier to pinpoint exactly where the irradiation should
be delivered in the artery and exactly what dose should be prescribed. "It allows us to map our strategy much
more accurately and deliver the radiation more precisely," she said.
All patients involved in the study will receive careful follow-up examinations for two years to determine the procedure's
effectiveness.
Anyone who has suffered from restenosis and is interested in participating in Beth Israel's Coronary Brachytherapy
study, should contact Denise McDermott, M.S.N., A.C.R.N., Research Associate, at (212) 420-2416.