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, Gennaro; Dambrosio, A.; Nusca, A.; Melfi, R.; Mangiacapra, F.; Gatto, L.; Dicuonzo, G.; Pasceri, V.; Speciale, G.; Pristipino, C.; Santini, M.; Pelliccia, F.; Colonna, G.; Montinaro, A.; Ciccirillo, F.; Tondo, A.; Picani, C.; Picciolo, A.; Greco, S.; Bergamo, A.; Colizzi, A.; Quarta, L.; Sardella, G.; Nguyen, BICH LIEN. - 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.
