Conflict of interest: Nothing to report.
Coronary Artery Disease
Rosuvastatin pretreatment in patients undergoing elective PCI to reduce the incidence of myocardial periprocedural necrosis: The ROMA trial†
Article first published online: 8 NOV 2012
Copyright © 2012 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions
Volume 81, Issue 1, pages E36–E43, 1 January 2013
How to Cite
Sardella, G., Conti, G., Donahue, M., Mancone, M., Canali, E., De Carlo, C., Di Roma, A., Calcagno, S., Lucisano, L. and Fedele, F. (2013), Rosuvastatin pretreatment in patients undergoing elective PCI to reduce the incidence of myocardial periprocedural necrosis: The ROMA trial. Cathet. Cardiovasc. Intervent., 81: E36–E43. doi: 10.1002/ccd.24403
- Issue published online: 21 DEC 2012
- Article first published online: 8 NOV 2012
- Accepted manuscript online: 19 APR 2012 07:08AM EST
- Manuscript Accepted: 2 MAR 2012
- Manuscript Revised: 22 JAN 2012
- Manuscript Received: 4 SEP 2011
- myocardial necrosis;
- elective coronary angioplasty;
The aim of this study is to assess the efficacy of the high-dose rosuvastatin preadministration in reducing periprocedural myocardial necrosis and major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing elective percutaneous coronary intervention (PCI).
Elective PCI may be complicated with an elevation of cardiac biomarkers. Several studies suggested that pretreatment with statins may be associated with a reduction in periprocedural myocardial necrosis.
One hundred and sixty patients with stable angina who underwent elective PCI were randomly assigned to receive either a preprocedural loading dose (40 mg) of rosuvastatin group (RG, n = 80) or a standard treatment [control group (CG), n = 80].The primary endpoint was the incidence of periprocedural myocardial necrosis. The secondary endpoint was the assessment of MACCE [cardiac death, all-myocardial infarction (MI), stroke, and target vessel revascularization (TVR)] at a 30-day and 12-month follow-up, as well as the rate of periprocedural rise of Troponin T-serum levels >3× upper limit of normal.
Twelve and 24-hr post-PCI creatinine kinase MB isoform elevation >3× 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 MACCE was 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.
High loading dose of rosuvastatin within 24 hr 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.