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ARMYDA-RELOAD: Clopidogrel reload yielded benefit for patients with ACS
Patients with stable angina derived no benefit from additional clopidogrel.
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CHICAGO – Patients with acute coronary syndrome who were prescribed chronic clopidogrel therapy derived clinical benefit from an additional reloading dose of clopidogrel during percutaneous coronary intervention, study results have suggested.
Researchers for the European, multi-center Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty (ARMYDA-RELOAD) trial evaluated the effects of a 600-mg reloading dose of clopidogrel (Plavix, Sanofi Aventis/Bristol-Meyers Squibb) on clinical endpoints in patients with both ACS and stable angina. The results were presented at the 2008 Society of Coronary Angiography and Interventions Annual Scientific Sessions/American College of Cardiology i2 Summit held here recently.
“The rationale of the study is supported by previous evidence that shows that 600 mg of clopidogrel is associated with intense platelet inhibition, which is similar to what is obtained in patients that regularly take 75 mg clopidogrel per day,” Germano DiSciascio, MD, professor of cardiology at Campus Biomedico at the University of Rome, said during a presentation. “However, the latter patient, when given a frontal load of 600 mg of clopidogrel, achieved a further degree of platelet inhibition. Whether this would correspond to improved clinical outcomes is still to be demonstrated.”
Sicker patients benefited
The researchers enrolled 436 patients prescribed chronic clopidogrel therapy undergoing PCI, and randomly assigned them to either placebo (n=217) or a 600-mg reloading dose of clopidogrel (n=219). The researchers then divided the sample into a stable angina group (n=269) and an ACS group (n=167). The primary endpoint was 30-day incidence of death, MI or target vessel revascularization.
The primary endpoint occurred in 7% of patients in the clopidogrel reload group vs. 9% in the placebo group (P=.70). Periprocedural MI occurred in patients from both arms of the study. Patients with ACS assigned to the reloading group had clinical benefit (OR=0.36; 95% CI, 0.29-0.92) and a lower rate of major adverse cardiac events (7% vs. 18%).
“The ARMYDA-RELOAD trial indicates that a significant proportion of patients undergoing PCI are indeed receiving chronic clopidogrel therapy,” DiSciascio said. “Patients with stable angina who are already taking clopidogrel can safely undergo PCI without need of further reload.”
Discussant Peter M. Berger, MD, associate chief research officer at Geisinger Clinic in Danville, Pa., viewed the trial results as negative, yet instructive.
“The trial ought to be considered a negative trial, in that 600 mg of clopidogrel in patients who are already taking 75 mg per day did not improve outcomes to a significant degree,” Berger said. “Despite my emphasis that this is a negative trial and that we be very cautious about subgroups that appear to benefit from a negative trial I would probably continue to recommend reloading for patients who are regularly taking clopidogrel or who claim to be taking their clopidogrel for both higher and lower risk patients.” — by Eric Raible
For more information:
- DiSciascio G, Patti G, Colonna G, et al. Results of the Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-reload (ARMYDA-RELOAD) randomized trial. #2411-11. Presented at: 2008 Society of Coronary Angiography and Interventions Annual Scientific Sessions/American College of Cardiology i2 Summit; March 28–April 1, 2008; Chicago.