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ARMYDA-5.

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  1. ARMYDA-5 Trial Design: ARMYDA-5 was a randomized trial ofpretreatment with 600 mg clopidogrel loading dose (n = 174) 4 to 8 hours prior to angiography or loading with clopidogrel in the cath lab after defining the anatomy only when the need for PCI was confirmed (n = 176) in patients undergoing PCI. Primary endpoint was death, MI, or target vessel revascularization (TVR) at 30 days. • Results • No difference in primary endpoint of death, MI, or TVR at 30 days between groups (Figure); all of events in composite endpoint were MIs • Platelet reactivity ↓ in pretreatment group vs. cath lab group at time of PCI (241 vs. 272 PRU, p = 0.04) and 2 hours (186 vs. 245 PRU, p = 0.005); no difference in platelet reactivity at 6 hours and 24 hours • Minor bleeding did not differ between groups (Figure); no major bleeds in either arm • Conclusions • Among patients undergoing PCI, preloading with 600 mg of clopidogrel was not associated with difference in primary endpoint of death, MI, or TVR at 30 days vs. loading in cath lab once anatomy was defined • Data were similar to PRAGUE 8, which showed no difference in death, MI, stroke, TIA, or reintervention compared with selective clopidogrel use during angiography if PCI was needed • Sample size was small and likely underpowered to detect difference in clinical events; however, also no differences seen in continuous biomarker measures, which provide more power Death, MI, TVR at 30 Days (p = 0.56) Minor Bleeding at 30 Days (p = NS) % In-Lab Treatment Pretreatment Presented at TCT 2007

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