Objectives: This study sought to evaluate safety and effectiveness of in-laboratory (in-lab) 600-mg clopidogrel loading pre-percutaneous coronary intervention (PCI) versus routine 6-h pre-load. Background: Clopidogrel pre-treatment significantly improves outcome in patients undergoing PCI; however, efficacy of an in-lab loading strategy before PCI after coronary angiography versus routine pre-load has not been fully characterized. Methods: A total of 409 patients (39% with acute coronary syndrome) were randomized to receive a 600-mg clopidogrel loading dose 4 to 8 h before PCI (pre-load group, n = 204) or a 600-mg loading dose given in the catheterization lab after coronary angiography, but prior to PCI (in-lab group, n = 205). Primary end point was 30-day incidence of major adverse cardiac events: cardiac death, myocardial infarction (MI), or unplanned target vessel revascularization. Results: There was no significant difference in primary end point between the 2 randomization arms (8.8% in-lab vs. 10.3% pre-load; p = 0.72); this was mainly driven by periprocedural MI (8.8% vs. 9.3%, p = 0.99). No increased risk of bleeding or vascular complications was observed in the pre-load arm (5.4% vs. 7.8%; p = 0.42). As determined by the VerifyNow assay (Accumetrics, San Diego, California), patients in the in-lab group showed higher platelet reactivity during PCI and 2 h after intervention versus those in the pre-load arm (p ≤ 0.043). Conclusions: ARMYDA-5 PRELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) trial indicates that a strategy of 600-mg in-lab clopidogrel load pre-PCI may have similar clinical outcomes as routine 4- to 8-h pre-load. Thus, when indicated, in-lab clopidogrel administration can be a safe alternative to routine pre-treatment given before knowing patients' coronary anatomy. © 2010 American College of Cardiology Foundation.
Effectiveness of in-laboratory high-dose clopidogrel loading versus routine pre-load in patients undergoing percutaneous coronary intervention: Results of the ARMYDA-5 PRELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial / Di Sciascio, G., Patti, G., Pasceri, V., Gatto, L., Colonna, G., Montinaro, A., Armyda Preload Investigators Collaborators Di Sciascio, G., Patti, G., Pasceri, V., Colonna, G., Sardella, G., Dambrosio, A., Nusca, A., Melfi, R., Mangiacapra, F., Gatto, L., Dicuonzo, G., Pasceri, V., Speciale, G., Pristipino, C., et al.. - In: JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. - ISSN 0735-1097. - STAMPA. - 56:7(2010), pp. 550-557. [10.1016/j.jacc.2010.01.067]
Effectiveness of in-laboratory high-dose clopidogrel loading versus routine pre-load in patients undergoing percutaneous coronary intervention: Results of the ARMYDA-5 PRELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial
SARDELLA, Gennaro;F. Pelliccia;NGUYEN, BICH LIEN
2010
Abstract
Objectives: This study sought to evaluate safety and effectiveness of in-laboratory (in-lab) 600-mg clopidogrel loading pre-percutaneous coronary intervention (PCI) versus routine 6-h pre-load. Background: Clopidogrel pre-treatment significantly improves outcome in patients undergoing PCI; however, efficacy of an in-lab loading strategy before PCI after coronary angiography versus routine pre-load has not been fully characterized. Methods: A total of 409 patients (39% with acute coronary syndrome) were randomized to receive a 600-mg clopidogrel loading dose 4 to 8 h before PCI (pre-load group, n = 204) or a 600-mg loading dose given in the catheterization lab after coronary angiography, but prior to PCI (in-lab group, n = 205). Primary end point was 30-day incidence of major adverse cardiac events: cardiac death, myocardial infarction (MI), or unplanned target vessel revascularization. Results: There was no significant difference in primary end point between the 2 randomization arms (8.8% in-lab vs. 10.3% pre-load; p = 0.72); this was mainly driven by periprocedural MI (8.8% vs. 9.3%, p = 0.99). No increased risk of bleeding or vascular complications was observed in the pre-load arm (5.4% vs. 7.8%; p = 0.42). As determined by the VerifyNow assay (Accumetrics, San Diego, California), patients in the in-lab group showed higher platelet reactivity during PCI and 2 h after intervention versus those in the pre-load arm (p ≤ 0.043). Conclusions: ARMYDA-5 PRELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) trial indicates that a strategy of 600-mg in-lab clopidogrel load pre-PCI may have similar clinical outcomes as routine 4- to 8-h pre-load. Thus, when indicated, in-lab clopidogrel administration can be a safe alternative to routine pre-treatment given before knowing patients' coronary anatomy. © 2010 American College of Cardiology Foundation.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
