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

• Published in: International journal of cardiology 2013-10, Vol.168 (4), p.3715-3720
• Main Authors: Sardella, Gennaro, Lucisano, Luigi, Mancone, Massimo, Conti, Giulia, Calcagno, Simone, Stio, Rocco E., Pennacchi, Mauro, Biondi-Zoccai, Giuseppe, Canali, Emanuele, Fedele, Francesco
• Format: Article
• Language: English
• Subjects: Aged; Angina, Stable - drug therapy; Angina, Stable - pathology; Angina, Stable - surgery; Atorvastatin Calcium; Biological and medical sciences; Cardiology. Vascular system; Coronary heart disease; Diseases of the cardiovascular system; Elective coronary angioplasty; Elective Surgical Procedures - adverse effects; Female; Fluorobenzenes - administration & dosage; Follow-Up Studies; Heart; Heptanoic Acids - administration & dosage; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Incidence; Male; Medical sciences; Middle Aged; Myocardial Infarction - epidemiology; Myocardial Infarction - pathology; Myocardial Infarction - prevention & control; Myocardial necrosis; Necrosis; Percutaneous Coronary Intervention - adverse effects; Postoperative Complications - epidemiology; Postoperative Complications - pathology; Postoperative Complications - prevention & control; Preoperative Care - methods; Pyrimidines - administration & dosage; Pyrroles - administration & dosage; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Rosuvastatin Calcium; Statin reload; Sulfonamides - administration & dosage; Treatment Outcome
• ISSN: 0167-5273; 1874-1754
• DOI: 10.1016/j.ijcard.2013.06.017

The objective of this study is to compare a reloading dose of Rosuvastatin and Atorvastatin administered within 24h 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. 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. Three hundred and fifty patients with stable angina who underwent elective PCI were randomly assigned to receive a pre-procedural reloading dose of Rosuvastatin (40mg) (Rosuvastatin Group—RG n=175) or Atorvastatin (80mg) (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,6–12month follow-up. Also we evaluate the rise of periprocedural Troponin T serum levels >3× the upper limit of normal. 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. 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.