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 < or = 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. Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
RCT Entities:
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 < or = 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. Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Authors: José Carlos Nicolau; Gilson Soares Feitosa Filho; João Luiz Petriz; Remo Holanda de Mendonça Furtado; Dalton Bertolim Précoma; Walmor Lemke; Renato Delascio Lopes; Ari Timerman; José A Marin Neto; Luiz Bezerra Neto; Bruno Ferraz de Oliveira Gomes; Eduardo Cavalcanti Lapa Santos; Leopoldo Soares Piegas; Alexandre de Matos Soeiro; Alexandre Jorge de Andrade Negri; Andre Franci; Brivaldo Markman Filho; Bruno Mendonça Baccaro; Carlos Eduardo Lucena Montenegro; Carlos Eduardo Rochitte; Carlos José Dornas Gonçalves Barbosa; Cláudio Marcelo Bittencourt das Virgens; Edson Stefanini; Euler Roberto Fernandes Manenti; Felipe Gallego Lima; Francisco das Chagas Monteiro Júnior; Harry Correa Filho; Henrique Patrus Mundim Pena; Ibraim Masciarelli Francisco Pinto; João Luiz de Alencar Araripe Falcão; Joberto Pinheiro Sena; José Maria Peixoto; Juliana Ascenção de Souza; Leonardo Sara da Silva; Lilia Nigro Maia; Louis Nakayama Ohe; Luciano Moreira Baracioli; Luís Alberto de Oliveira Dallan; Luis Augusto Palma Dallan; Luiz Alberto Piva E Mattos; Luiz Carlos Bodanese; Luiz Eduardo Fonteles Ritt; Manoel Fernandes Canesin; Marcelo Bueno da Silva Rivas; Marcelo Franken; Marcos José Gomes Magalhães; Múcio Tavares de Oliveira Júnior; Nivaldo Menezes Filgueiras Filho; Oscar Pereira Dutra; Otávio Rizzi Coelho; Paulo Ernesto Leães; Paulo Roberto Ferreira Rossi; Paulo Rogério Soares; Pedro Alves Lemos Neto; Pedro Silvio Farsky; Rafael Rebêlo C Cavalcanti; Renato Jorge Alves; Renato Abdala Karam Kalil; Roberto Esporcatte; Roberto Luiz Marino; Roberto Rocha Corrêa Veiga Giraldez; Romeu Sérgio Meneghelo; Ronaldo de Souza Leão Lima; Rui Fernando Ramos; Sandra Nivea Dos Reis Saraiva Falcão; Talia Falcão Dalçóquio; Viviana de Mello Guzzo Lemke; William Azem Chalela; Wilson Mathias Júnior Journal: Arq Bras Cardiol Date: 2021-07 Impact factor: 2.667