AHA: Year-Long Clopidogrel Therapy Reduces Coronary Events in Angioplasty-eligible Patients
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AHA: Year-Long Clopidogrel Therapy Reduces Coronary Events in Angioplasty-eligible Patients

By Ed Susman

CHICAGO, IL -- November 19, 2002 -- Angioplasty-eligible patients assigned to year-long clopidogrel treatment appear to have significantly reduced rates of coronary and stroke events, researchers reported here November 18 at the 2002 Scientific Sessions of the American Heart Association (AHA).

During a late-breaker oral presentation, doctors reported a 27 percent reduction in the combined primary end point of death, heart attack or stroke in the intent-to-treat population of 2,118 people. The reduction achieved statistical significance at the p=0.02 level.

Steven Steinhubl, MD, associate professor of medicine at University of North Carolina, in Chapel Hill, North Carolina, United States, and his colleagues recruited patients in 99 centers in the United States and Canada for the Clopidogrel for the Reduction of Events During Observation (CREDO) trial.

Dr. Steinhubl said that current treatment calls for four-week administration of clopidogrel and aspirin for anti-platelet aggregation in patients who undergo angioplasty. In the CREDO trial, 85 percent of patients actually underwent the procedures, another 4 percent were treated with coronary artery bypass surgery, and the remaining 11 percent were treated medically.

Patients assigned to clopidogrel remained on the drug for one year along with aspirin therapy. The placebo cohort took clopidogrel for four weeks and then placebo for a year along with aspirin therapy.

"The risk of heart attack and stroke remains high for the life of these patients even after the angioplasty treatment," De. Steinhubl said. His results showed that clopidogrel reduced incidence of death by 24.6 percent, heart attacks by 21.7 percent, stroke by 25.1 percent and heart attack deaths by 24 percent compared to placebo.

"Long-term use of clopidogrel and aspirin will become the standard of care for patients who are eligible for angioplasty for at least a year," said Dr. Valentin Fuster, professor of cardiology at the Mount Sinai School of Medicine, in New York, United States.

A second part of the CREDO trial attempted to see if pre-loading with clopidogrel affected outcomes after angioplasty. Dr. Steinhubl said the researchers found significant prevention of vascular events if patients received the loading dose of clopidogrel at least six hours before the surgical procedure, achieving statistical significance at the p=0.05 level. The loading dose looked at outcomes after 28 days.

The trial was supported by Bristol Myers Squibb and Sanofi-Synthelabo.

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