title: Rosuvastatin for Reduction of Myocardial Damage during Coronary Angioplasty - the Remedy Trial.
abstract: BACKGROUND
  Periprocedural myocardial infarction (MI) is a frequent complication of percutaneous coronary intervention (PCI). Statins might reduce its incidence. The aims of the present study are to assess whether such benefit is a class-effect or whether differences exist between various lipid-lowering strategies and whether cardioprotection is exerted by increasing circulating endothelial progenitor cells (EPCs).
  
  
  METHODS
  The REMEDY study will enroll a total of 1080 patients submitted to elective PCI. Eligible patients will be randomized into 4 groups: 1) placebo; 2) atorvastatin (80 mg + 40 mg before PCI); 3) rosuvastatin (40 mg twice before PCI); and 4) rosuvastatin (5 mg) and ezetimibe (10 mg) twice before PCI. Peri-procedural MI is defined as an elevation of markers of cardiac injury (either CK-MB or troponin I or T) values >5x the upper reference limit estimated at the 99th percentile of the normal distribution, or a rise >20 % in case of baseline values already elevated. EPCs will be assessed before, at 24 h and - in a subset of diabetic patients - at 3 months after PCI (EPC-substudies). The primary endpoint of the main REMEDY study is the rate of peri-procedural MI in each of the 4 treatment arms. Secondary endpoints are the combined occurrence of 1-month major adverse events (MACE, including death, MI, or the need for unplanned revascularization); and any post-procedural increase in serum creatinine. Endpoints of the EPC-substudies are the impact of tested regimens on 1) early (24-h) and 3-month EPC levels and functional activity; 2) stent strut re-endothelialization and neointimal hyperplasia; 3) 1-year MACE. REMEDY will add important information on the cardioprotective effects of statins after PCI.
authors.affiliation: Clinica Mediterranea, Naples, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
authors.affiliation: Institute of Cardiology and Center of Excellence on Aging, "G. d'Annunzio" University - Chieti, C/o Ospedale SS. Annunziata, Via dei Vestini, 66013, Chieti, Italy.
authors.forename: Rosalinda
authors.initials: R
authors.lastname: Madonna
authors.affiliation: Institute of Cardiology and Center of Excellence on Aging, "G. d'Annunzio" University - Chieti, C/o Ospedale SS. Annunziata, Via dei Vestini, 66013, Chieti, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Zimarino
authors.affiliation: Department of Cardiothoracic Sciences, Monaldi Hospital, Second University of Naples, Naples, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Calabrò
authors.affiliation: Department of Molecular Medicine and Medical Biotechnologies, "Federico II" University of Naples, Naples, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Quintavalle
authors.affiliation: Dimensione Ricerca, Milan, Italy.|ES Health Science Foundation, Lugo, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Salomone
authors.affiliation: Department of Molecular Medicine and Medical Biotechnologies, "Federico II" University of Naples, Naples, Italy.
authors.forename: Gerolama
authors.initials: G
authors.lastname: Condorelli
authors.affiliation: Institute of Cardiology and Center of Excellence on Aging, "G. d'Annunzio" University - Chieti, C/o Ospedale SS. Annunziata, Via dei Vestini, 66013, Chieti, Italy. rdecater@unich.it.
authors.forename: Raffaele
authors.initials: R
authors.lastname: De Caterina
mesh_terms: D000293:Adolescent; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D000069059:Atorvastatin / Q000627:therapeutic use; D002316:Cardiotonic Agents / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000601:surgery*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000069438:Ezetimibe / Q000627:therapeutic use; D006321:Heart / Q000187:drug effects; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D000068718:Rosuvastatin Calcium / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D002316:Cardiotonic Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000068718:Rosuvastatin Calcium; D000069059:Atorvastatin; D000069438:Ezetimibe
keywords: Cardioprotection; Endothelial progenitor cells; PCI; Percutaneous coronary intervention; Periprocedural myocardial infarction; Statins