Reloading With Clopidogrel Improves Clinical Outcomes in Patients with Acute Coronary Syndromes: ARMYDA-RELOAD

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April 1, 2008 By Alexandra M. Palmer [1]

SCAI-ACCi2 08-Chicago, IL: Results from the ARMYDA-RELOAD trial demonstrate improved clinical outcomes when patients with acute coronary syndromes already on clopidogrel are administered an additional 600 mg prior to PCI but not in patients with stable angina. The data was presented by Dr. Germano Di Sciascio at the SCAI-ACC i2 summit Annual Scientific Sessions in Chicago today.

The goal of ARMYDA-RELOAD (Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-RELOAD) was to evaluate the safety and efficacy of a 600 mg clopidogrel re-load in patients with acute coronary syndromes (ACS) and in patients with stable angina.

In this trial, 436 patients who were treated with clopidogrel therapy for more than 10 days prior to PCI were randomized to either an additional 600 mg of clopidogrel (n = 219) or to placebo (n = 217). 167 of these patients presented with ACS. The primary endpoint was the combined risk of death, myocardial infarction and target vessel revascularization. Follow-up time was 30 days.

The primary endpoint was not significant in the overall population (9% vs. 7%, p=0.7) and among patients with stable angina (4% vs. 8%, p=0.23) between the placebo group and the reload groups respectively. However, the reload strategy was beneficial in patients with ACS (7%-reload vs. 18%-no reload, p=0.035). There was no significant difference in the occurrence of bleeding events between the placebo and the reload groups both among patients with stable angina and those with ACS. The platelet reaction unit measured on platelet aggregometry tests demonstrated significant reduction in patients reloaded with clopidogrel in the overall population (p=0.01) and in the ACS group (p=0.046).

The investigators concluded that patients with stable angina who are already taking clopidogrel can safely undergo PCI without need of further reload. On the other hand, the reload strategy was beneficial among patients with ACS.

This is the first study to analyze the effect of clopidogrel reloading on patients with ACS.

Sources

1. Germano Di Sciascio, Giuseppe Patti, Giuseppe Colonna, Vincenzo Pasceri, Andrea D’Ambrosio, Fabio Mangiacapra, Laura Gatto, Gennaro Sardella, Antonio Montinaro, Francesco Ciccirillo. Clopidogrel Reloading Before Percutaneous Coronary Intervention Improves Outcome in Patients With Acute Coronary Syndromes Receiving Chronic Clopidogrel Therapy. Results of the Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-RELOAD (ARMYDA-RELOAD) Randomized Trial.
2. Late Breaking Clinical Trials Session: SCAI Annual Scientific Sessions in partnership with ACC i2 summit, April 1, 2008 Chicago

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