title: Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic clopidogrel therapy: results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial.
abstract: OBJECTIVE
  To evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy undergoing percutaneous coronary intervention (PCI).
  
  
  RESULTS
  Five hundred and three patients on >10 days clopidogrel therapy (41% with non-ST-segment elevation acute coronary syndrome, ACS) randomly received 600 mg clopidogrel loading 4-8 h before PCI (n = 252) or placebo (n = 251). Primary endpoint was 30-day incidence of major adverse cardiac events (MACE). In the overall population primary endpoint occurred in 6.7% of patients in the reload vs. 8.8% in the placebo arm [odds ratios (OR) 0.75, 95% confidence intervals (CI) 0.37-1.52; P = 0.50]. In stable angina patients, 1-month MACE were not significantly different (7.0 vs. 3.9%; OR 1.84, 0.60-5.88; P = 0.36), whereas ACS patients had significant clinical benefit with reloading (6.4 vs. 16.3%; OR 0.34, 95% CI 0.32-0.90, P = 0.033 at multivariable analysis; interaction test: P = 0.01). There was no excess bleeding in the reload arm (6% in both groups).
  
  
  CONCLUSIONS
  ARMYDA-4 RELOAD reveals no overall benefit from reloading patients on chronic clopidogrel therapy prior to PCI; the benefit observed in ACS patients is a hypothesis-generating finding that needs to be confirmed by larger studies.
authors.affiliation: Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Via Alvaro del Portillo 200, 00128 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: Giuseppe
authors.initials: G
authors.lastname: Colonna
authors.forename: Fabio
authors.initials: F
authors.lastname: Mangiacapra
authors.forename: Antonio
authors.initials: A
authors.lastname: Montinaro
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D015415:Biomarkers / Q000378:metabolism; D000077144:Clopidogrel; D003323:Coronary Aneurysm; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D009204:Myocardial Revascularization / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011446:Prospective Studies; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine