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Drug Prevents Angioplasty Complications Years After Single Treatment

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Duke Health News 919-660-1306

BIRMINGHAM, U.K. -- One-time use of a drug that stops clots
from forming has significantly reduced life-threatening
complications from angioplasty both immediately and up to three
years after treatment, researchers from The Cleveland Clinic
Foundation and Duke University Medical Center reported
Monday.

New data from two clinical trials that tested the value of a
monoclonal antibody called ReoPro were prepared for
presentation at scientific sessions this week at the annual
European Society of Cardiology meeting in Birmingham, United
Kingdom.

The findings in the trial called EPILOG (Evaluation in PTCA
to Improve Long-term Outcome with ReoPro GP IIb/IIIa blockage)
show that one-month after treatment, overall death, recurrent
heart attacks and urgent repeat angioplasty or by-pass surgery
were reduced by up to 59 percent in all patients who were
treated with an injection and 12 hours of infusion of ReoPro,
compared to patients who didn't receive the drug.

The 30-day data also demonstrated that for every 1,000
patients who received ReoPro at the time of their angioplasty,
50 fewer patients suffered heart attacks, 36 fewer needed
follow-up, emergency angioplasties or by-pass surgery, and five
more people were alive compared to 1,000 patients who did not
receive ReoPro.

Data from the trial called EPIC (Evaluation of c7E3 for
Prevention of Ischemic Complications), which followed high-risk
patients for years after angioplasty, found that after three
years, there were 100 fewer cases of repeat procedures
(angioplasty or by-pass surgery) among those who received
ReoPro. Furthermore, there was a 60 percent reduction in
mortality in EPIC patients who had suffered from acute heart
attacks or unstable angina at the time of their
angioplasty.

"These findings are highly promising; a new way to make
angioplasty a safer and more lasting treatment for heart
disease," said Dr. Eric J. Topol, chairman of the department of
cardiology at The Cleveland Clinic Foundation. Topol and Dr.
Robert Califf, director of the Duke Clinical Research
Institute, were co-leaders for the studies.

Both trials were double-blinded, placebo-controlled and
randomized. EPIC enrolled 2,099 high-risk patients at 56
hospitals in the United States. In EPILOG, 2,792 patients at
varied risks were studied at 69 hospitals in the United States
and Canada.

Angioplasty is an increasingly popular technique to relieve
the plaque blockages that clog arteries around the heart. More
than 800,000 patients worldwide are annually treated with the
procedure, which uses a small balloon to open blocked vessels.
However, new blockages in the form of blood clots quickly occur
in up to 10 percent of patients, resulting in an increased risk
of death from a heart attack. Such blockages often require an
emergency heart bypass operation or another angioplasty
procedure.

Because substantial numbers of patients treated with ReoPro
will not have to return to the hospital for such complications,
the researchers said they believe that the price of the drug--
more than $1,000 per treatment in the United States -- will
provide an ultimate savings to society in the cost of treating
heart disease.

Califf called the study a "milestone in heart research."
After the first study, EPIC, found that the combination of
ReoPro and high-doses of the blood thinner heparin was
significantly beneficial in preventing new clots but caused
excess bleeding in some high-risk patients, scientists went
back to the drawing board, and designed EPILOG as a follow-up
study. EPILOG showed that the same use of ReoPro, but combined
with lower doses of heparin, was much more effective in
protecting patients from both recurrent clots and bleeding. The
beneficial effect was so substantial that an independent
committee of experts monitoring the study stopped the trial
early.

"We were able to take an experimental drug that appeared
very promising but had drawbacks in its first trial because of
bleeding, and tailor the treatment and study it again," Califf
said. "The result is that we now have a proven therapy that I
think should be routinely used with most angioplasty
procedures.

"This is a wonderfully protective drug that heralds a new
era for angioplasty in which better devices, such as stents,
and drugs are used in combination." Califf said. "Amazingly,
the benefit of its use just gets stronger as time passes. It
seems not only to stop the initial formation of clots, but also
prevents the recurrence of blockage in the vessel months or
years later."

The EPIC study was funded by Centocor Inc., of Malvern, Pa.,
which manufactures ReoPro. EPILOG was funded by both Centocor
and Eli Lilly and Co., of Indianapolis, Ind., which markets the
drug.

The presentation in Europe was the first presentation of
complete data on both studies. Initial and six-month results on
the 2,099 EPIC patients were published in the April 7, 1994,
issue of the New England Journal of Medicine and on April 9,
1994, in The Lancet. A report in the August 15, 1996, issue of
Circulation, using the six-month data from EPIC, found that
while the drug reduces short and long-term complications, it
cost the health care system no more than standard
treatment.

The new EPIC data showed that the number of complications --
heart attacks, repeat angioplasty and death -- that were
prevented by using ReoPro remains significantly high through
the three years these high-risk patients have been followed,
researchers said. At 6 months, 23 percent of complications were
prevented, compared to 20 percent after one year, 14 percent
after two years, and 13 percent after three years.

Initial results of EPILOG, presented in March at the annual
meeting of the American College of Cardiology, showed that in
1,500 patients studied, there was a relative decrease of 68
percent in death and heart attack among patients who were
treated with ReoPro. That is almost twice the benefit shown in
the EPIC study, which included only high-risk patients.
Importantly, the risk of bleeding was significantly reduced in
these patients, according to Topol.

Complete results from all 2,792 patients now show that there
was a 70 percent reduction in complications for patients who
used low doses of heparin, and a 50 percent reduction in those
who were treated with higher doses of heparin.

This proves that ReoPro works best when combined with lower
doses of heparin, Califf said.

ReoPro is the first monoclonal antibody approved by the U.S.
Food and Drug Administration that can be used as an active
disease treatment therapy, Califf said. Also known in its
experimental form as c7E3 Fab, it is derived from mouse and
human immune cells.

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