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Anti-Clotting Drug Used During Angioplasty Reduces Need for Subsequent Bypass Surgery

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Duke Health News 919-660-1306

ORLANDO, FL -- An analysis of data from three multi-center
trials has shown that 19 percent fewer angioplasty patients
required coronary artery bypass graft surgery within six months
if they received a monoclonal antibody drug just prior to the
procedure, Duke University Medical Center researchers reported
Monday.

Previous studies already have demonstrated the ability of
the drug Abciximab (trade name ReoPro) to reduce the need for
subsequent urgent coronary artery bypass graft (CABG) surgery
within 30 days and six months of angioplasty. The current
analysis, which involved 5,641 patients, demonstrated that the
benefits of ReoPro include a reduction in the incidence of both
urgent and non-urgent CABG surgery within six months of
angioplasty.

The researchers said the reduction in the number of surgical
procedures in this group of patients represents an important
cost savings in the treatment of heart patients.

"Since procedures, such as CABGs, are the major drivers in
the costs of cardiac care, this study further demonstrates the
cost-effectiveness of this drug," said Duke's Dr. Barbara
Tardiff, the study's author. "The data showed that those
patients who received ReoPro were 19 percent less likely to
need a CABG within 6 months. That is a statistically
significant difference."

In the United States, the average cost for a dose of ReoPro
is $1,350, while the combined costs associated to a surgical
procedure such as coronary bypasses can be as high as $44,000,
according to the American Heart Association (AHA).

The results of Tardiff's study were prepared for
presentation Monday at the scientific sessions of the 70th
annual scientific meeting of the AHA.

Specifically, Tardiff found that 8.5 percent of the patients
who received a placebo needed a bypass within six months of
their angioplasty, compared to 6.7 percent of those who
received intravenous ReoPro before the procedure.

"By pulling together the results of three large multi-center
trials and analyzing them, we could better ask the question,
'Does this drug reduce the need for all bypass surgeries, not
just those shortly after angioplasty?'" said Tardiff. "The
answer is yes. The beneficial effects we saw at 30 days were
sustained to six months."

ReoPro, a monoclonal antibody (c7E3 Fab), works by clogging
up receptors on platelets in the blood. This receptor, called
the glycoprotein IIb/IIIa receptor, normally binds to "adhesion
molecules" such as fibrinogen, which forms bridges with other
platelet cells, producing a clot. By plugging into the
receptor, ReoPro takes the place of the adhesion molecule and
prevents clots.

In 8 percent to 15 percent of all patients undergoing
angioplasty -- in which a small balloon inserted into clogged
arteries opens them up -- new blockages in the form of blood
clots quickly occur, resulting in an increased risk of death
from a heart attack, Tardiff said.

About 800,000 angioplasties are performed each year
worldwide.

Tardiff said she found certain patient characteristics in
the new analysis were particularly interesting.

"The CABG patients in the ReoPro group who needed bypass
surgery tended to be older (63 vs. 59), heavier (184 pounds vs.
176 pounds) and had diabetes (32.9 percent vs. 22.9 percent),"
Tardiff said.

"These differences were not observed in the treatment groups
overall," she continued. "This may suggest that ReoPro is
preventing CABG in the younger, healthier patients. Those
patients who required bypass after receiving angioplasty were
in a much higher risk class of patients."

The analysis of the data generated by the three different
trials was conducted by Tardiff and Keaven Anderson,
statistician for drug's manufacturer, Centocor, based in
Malvern, Pa.

Data from the following three trials were used:

EPIC (Evaluation of c7E3 for Prevention of Ischemic
Complications) -- Completed in 1992, this trial compared ReoPro
to placebo in high-risk patients.

EPILOG (Evaluation in PTCA to Improve Long-term Outcome with
ReoPro GP IIb/IIIa blockage) -- Completed in 1995, this trial
compared ReoPro to placebo in all risk categories of
patients.

CAPTURE (Chimeric 7E3 Anti-Platelet Therapy in Unstable
Angina Refractory to Standard Treatment) -- This trial,
completed in 1995, compared ReoPro to placebo in high-risk
patients with refractory unstable angina.

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