title: Comparison of high reloading ROsuvastatin and Atorvastatin pretreatment in patients undergoing elective PCI to reduce the incidence of MyocArdial periprocedural necrosis. The ROMA II trial.
abstract: OBJECTIVE
  The objective of this study is to compare a reloading dose of Rosuvastatin and Atorvastatin administered within 24 h before coronary angioplasty (PCI) in reducing the rate of periprocedural myonecrosis and major cardiac and cerebrovascular events (MACCE) in patients on chronic statin treatment undergoing elective PCI.
  
  
  BACKGROUND
  Elective PCI may be complicated with elevation of cardiac biomarkers. Several studies suggested that pretreatment with statins may be associated with a reduction in periprocedural myocardial necrosis.
  
  
  METHODS
  Three hundred and fifty patients with stable angina who underwent elective PCI were randomly assigned to receive a pre-procedural reloading dose of Rosuvastatin (40 mg) (Rosuvastatin Group-RG n=175) or Atorvastatin (80 mg) (Atorvastatin Group-AG n=175) and a control group on chronic statin therapy without reloading (Control-Group-CG). The primary end-point was periprocedural myocardial necrosis and the occurrence of MACCE at 30-day,6-12 month follow-up. Also we evaluate the rise of periprocedural Troponin T serum levels >3× the upper limit of normal.
  
  
  RESULTS
  Twelve and 24-hour post-PCI Creatine Kinase Muscle and Brain (CK-MB) elevation >3× occurred more frequently in the CG than in the RG and in the AG (at 24-h: 25.0 vs 7.1; p=0.003 and 25.0 vs 6.1; p=0.001). At 30-day, 6-and 12-month follow-up the incidence of cumulative MACCE was higher in CG than in the RG or AG (at 12-month: 41.0% vs 11.4% vs 12.0%; p=0.001). There was no difference between the RG and AG in terms of myocardial post-procedural necrosis and MACCE occurrence at follow-up.
  
  
  CONCLUSIONS
  High-dose statin reloading improves procedural and long term clinical outcomes in stable patients on chronic statin therapy. Both Rosuvastatin and Atorvastatin showed similar beneficial effects on procedural and long-term outcomes.
authors.affiliation: Cardiovascular, Respiratory, Nephrologic and Geriatric Sciences Department, Umberto I Hospital, Sapienza University of Rome, Rome, Italy. Electronic address: rino.sardella@uniroma1.it.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Sardella
authors.forename: Luigi
authors.initials: L
authors.lastname: Lucisano
authors.forename: Massimo
authors.initials: M
authors.lastname: Mancone
authors.forename: Giulia
authors.initials: G
authors.lastname: Conti
authors.forename: Simone
authors.initials: S
authors.lastname: Calcagno
authors.forename: Rocco E
authors.initials: RE
authors.lastname: Stio
authors.forename: Mauro
authors.initials: M
authors.lastname: Pennacchi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Biondi-Zoccai
authors.forename: Emanuele
authors.initials: E
authors.lastname: Canali
authors.forename: Francesco
authors.initials: F
authors.lastname: Fedele
mesh_terms: D000368:Aged; D060050:Angina, Stable / Q000188:drug therapy / Q000473:pathology / Q000601:surgery; D000069059:Atorvastatin; D017558:Elective Surgical Procedures / Q000009:adverse effects*; D005260:Female; D005464:Fluorobenzenes / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006538:Heptanoic Acids / Q000008:administration & dosage*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000473:pathology / Q000517:prevention & control*; D009336:Necrosis; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D011183:Postoperative Complications / Q000453:epidemiology / Q000473:pathology / Q000517:prevention & control*; D011300:Preoperative Care / Q000379:methods; D011743:Pyrimidines / Q000008:administration & dosage*; D011758:Pyrroles / Q000008:administration & dosage*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D005464:Fluorobenzenes; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; D000069059:Atorvastatin
keywords: Elective coronary angioplasty; Myocardial necrosis; Statin reload