Rosuvastatin pre-treatment in patients undergoing elective PCI to reduce the incidence of myocardial periprocedural necrosis. The ROMA trial
Catheterization and Cardiovascular Interventions, 04/30/2012
Sardella G et al. – High loading dose of Rosuvastatin within 24 hours before elective percutaneous coronary intervention (PCI) seems to decrease the incidence of periprocedural myocardial necrosis during a period of 12–months compared to the standard treatment.Methods
- 160 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.
- 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.