title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Via Alvaro del Portillo 200, Rome, Italy. g.disciascio@unicampus.it
authors.forename: Germano
authors.initials: G
authors.lastname: Di Sciascio
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Patti
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Pasceri
authors.forename: Laura
authors.initials: L
authors.lastname: Gatto
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colonna
authors.forename: Antonio
authors.initials: A
authors.lastname: Montinaro
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D000077144:Clopidogrel; D017023:Coronary Angiography; D005260:Female; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine