ARMYDA-5 PRELOAD: Clopidogrel administered in advance of PCI yielded similar outcomes to cath lab administration
Di Sciascio G. J Am Coll Cardiol. 2010;56:550–557.
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Dosage of clopidogrel in the catheterization lab was shown to produce similar clinical outcomes as the standard 4- and 8-hour preloads in patients who underwent percutaneous coronary intervention, according to results of the ARMYDA-5 PRELOAD trial.
The Italian researchers enrolled 409 patients in the study and randomly assigned them to receive either a 600 mg clopidogrel loading dose 4 to 8 hours prior to PCI (n=204) or a 600 mg loading dose given in the catheterization lab after coronary angiography, but prior to PCI (n=205). The primary endpoint was the 30-day incidence of the following major adverse cardiac events: cardiac death, MI or unplanned target vessel revascularization.
Researchers reported no significant difference in the primary endpoint between the two arms (8.8% in-lab vs. 10.3% pre-load), which was driven mainly by periprocedural MI. There was a minor increased risk of bleeding or vascular complications in the pre-load arm (7.8%) vs. the in-lab arm (5.4%). Additional findings showed that patients in the in-lab group showed higher platelet reactivity during PCI (P=.043) and 2 hours after intervention (P=.01) vs. those in the pre-load group, but the levels became similar at 8 and 24 hours.
The trial, the researchers wrote, indicates that a strategy of 600-mg in-lab clopidogrel load pre-PCI may have similar clinical outcomes as routine 4- to 8-hour pre-load. Thus, when indicated, in-lab clopidogrel administration can be a safe alternative to routine pre-treatment given before knowing patients coronary anatomy.
Goran Stankovic, MD, PhD, and Milorad Zivkovic, MD, both with the Medical School of Belgrade in Belgrade, Serbia, explained in an accompanying editorial that the study addresses a clinically relevant question with a randomized controlled trial, and that the results support the in-lab administration of clopidogrel as a safe alternative to routine pre-treatment given before knowing a patients anatomy.
This study serves the purpose of stimulating more and larger efforts to study the issue of clopidogrel platelet reactivity by developing either new regimens of the same drug or new drugs that have different, more predictable and more powerful effects on platelet function, such as prasugrel or ticagrelor, they concluded.
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