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

November 10, 1997

ORLANDO, Fla. -- 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:Others involved in the analysis were, from Duke, Dr. James Tcheng and Dr. Robert Califf; from Centocor, Dr. Catherine Cabot; from Thoraxcenter in Rotterdam, Netherlands, Dr. Jaap Deckers and Dr. Maarten Simoons; and Dr. Eric Topol, Cleveland Clinic.
-end-


Duke University Medical Center

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