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| |  ACC: Plavix (Clopidogrel) Helps Retain Patency of Reperfused Coronary Arteries By Ed Susman ORLANDO, FL -- March 10, 2005 -- The addition of Plavix (clopidogrel) to the thrombolytic regimen being used for treatment of acute myocardial infarction (MI) could dramatically increase the chance that a blood vessel that is opened by the lytic agents will stay unobstructed after 20 days. "Clopidogrel offers an effective, simple, inexpensive and safe mean by which to improve infarct-related patency and reduce ischemic complications," said Marc Sabatine, MD, Professor of Medicine, Harvard School of Medicine, Boston, Massachusetts, United States, here on March 9th at the American Academy of Cardiology 54th Scientific Session. Dr. Sabatine reported that the addition of clopidogrel, a potent anti-platelet agent, to the standard thrombolytic treatment resulted in a 36% reduction in relative risk that the artery blocked in the MI would re-occlude or that the patient would die or have another MI (P =.00000036), he said. Administration of clopidogrel also reduced by 20% the risk of cardiovascular death, MI or need for urgent revascularization through the 30-day period. The clinical benefits were achieved without increasing the risk of bleeding, Dr. Sabatine said as he reported the results of the Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY) - Thrombolysis in Myocardial Infarction (TIMI) 28 trial. Co-investigator Christopher P. Cannon, MD, Associate Professor of Medicine, Harvard School of Medicine, said that while primary angioplasty has a better efficacy in opening blocked arteries in patients having an acute ST-segment elevated MI, relatively few hospitals can offer that procedure in a timely manner, leaving thrombolysis as the only option available, usually using a tissue-plasminogen activator. In the study, 3,491 patients with acute MI were treated with a fibrinolytic agent, aspirin and heparin, and were randomized to receive either placebo or a 300 mg loading dose of clopidogrel followed by 75 mg of clopidogrel daily for 30 days. After 2 to 8 days, patients underwent angiographic evaluation of their coronary arteries. The study's primary endpoint was whether the target artery retained its patency at the time of angiography and/or if the patient had another MI or died. At the time of angiography, the composite endpoint occurred in 15% of the 1,752 patients taking clopidogrel and in 7% of the 1,739 patients on placebo. The rate of absolute reduction in second MI or death was about 7% and this benefit held for 30 days when patients in the clopidogrel arm. Clopidogrel, marketed as Plavix by Sanofi-Aventis and Bristol-Myers Squibb, is standard therapy for people who have blocked arteries opened by stents, Dr. Sabatine said. "It keeps the vessels open," he added. "This is a major finding," said Robert Bonow, MD, Chief of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States. "This likely to have a major impact."
[Presentation title: Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY): Thrombolysis in Myocardial Infarction (TIMI) 28. Abstract 415-3]
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