Rosuvastatin pre-treatment in patients undergoing elective PCI to reduce the incidence of myocardial periprocedural necrosis. The ROMA trial.

OBJECTIVES: The aim of this study is to assess the efficacy of the high-dose Rosuvastatin pre-administration in reducing periprocedural myocardial necrosis and major cardiovascular and cerebrovascular events(MACCE) in patients undergoing elective percutaneous coronary intervention (PCI). BACKGROUND: Elective PCI may be complicated with an elevation of cardiac biomarkers. Several studies suggested that pre-treatment with statins may be associated with a reduction in periprocedural myocardial necrosis. METHODS: One hundred and sixty patients with stable angina who underwent elective PCI were randomly assigned to receive either a pre-procedural loading dose (40 mg) of Rosuvastatin (RG n=80) or a standard treatment (CG n=80).The primary end-point was the incidence of periprocedural myocardial necrosis.The secondary end-point was the assessment of MACCE (cardiac death, all-MI,stroke and TVR) at a 30-day and 12-month follow-up, as well as the rate of periprocedural rise of Troponin T serum levels> 3xULN. RESULTS: Twelve and 24-hour post-PCI CK-MB elevation>3x occurred more frequently in the CG than in the RG (22.7 vs 7.1;p=0.034 and 26.4 vs 8.7;p=0.003).At the 30-day and 12-month follow-up the incidence of cumulative MACCEwas higher in CG than in the RG (30.0% vs 8.7%; p=0.001 and 35.0% vs 12.5%;p=0.001).The difference between the groups was mainly due to the periprocedural MI incidence (26.4% vs 8.7%;p=0.003).The rate of cardiac death, spontaneous MI, TVR and stroke were similar in the two groups. CONCLUSIONS: High loading dose of Rosuvastatin within 24 hours before elective PCI seems to decrease the incidence of periprocedural myocardial necrosis during a period of 12-months compared to the standard treatment. © 2012 Wiley Periodicals, Inc