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Double Dose of Clopidogrel Halves Angioplasty Complications: Presented at ACC
By Ed Susman
ORLANDO, FL -- March 7, 2006 -- The risk of complications from angioplasty could be substantially reduced if patients are started on a double dose of the platelet inhibitor clopidogrel.
"We can cut the risk of these complications by 50%," said Germano Di Sciascio, MD, Professor and Chairman of Cardiology, Campus Biomedico, University of Rome, Rome, Italy, in a late-breaking clinical trial presentation here on March 6th at the American College of Cardiology Annual Scientific Sessions 2005.
In the Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty (ARMYDA) trial, Dr. Di Sciascio and colleagues recruited 255 patients. Patients were divided into two groups; 126 received a clopidogrel loading dose of 600 mg about 6 hours before angioplasty, and 129 received 300 mg of clopidogrel, considered the standard dose.
The study was designed to determine if the double dose -- as observed in anecdotal and pilot studies -- offered greater protection against death, myocardial infarction or the need for target vessel revascularization within 30 days, the study's primary endpoint, with 4% of patients on clopidogrel 600 mg and 12% of patients on clopidogrel 300 mg.
Among the other findings, the researchers found that the overall risk of heart attack was reduced by 48% with clopidogrel 600 mg compared to the standard dose.
In a subgroup of patients who received the double dose of clopidogrel and statin therapy, the risk of events decreased by 80%.
The mean creatine kinase-myoglogin level -- a biomarker of heart damage -- was elevated above the normal limit after the procedure in 14% of patients on the 600 mg dose compared to 26% of the 300 mg group.
"The low risk of this pharmacological regimen may support its routine use in patients before planned coronary angioplasty and may influence practice patterns with regard to antiplatelet therapy before percutaneous intervention," Dr. Di Sciascio said during a press briefing on March 6th, just prior to presenting the data to the conference.
"I've been giving 600 mg to my high-risk angioplasty patients," said Lloyd Klein, MD, Professor of Medicine, Rush Medical School, Chicago, Illinois, United States. "Some doctors will begin to use this regimen tomorrow. Some will wait until new guidelines are published."
Dr. Di Sciascio said he now uses the regimen in his low- and medium-risk patients as well as high-risk patients.
[Presentation title: Randomized Trial of High Loading Dose of Clopidogrel for Reduction of Periprocedural Myocardial Infarction in Patients Undergoing Coronary Intervention. Late breaker presentation]
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