Male Vs Female Comparison of High Rosuvastatin and Atorvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of Myocardial Periprocedural Necrosis. The ROMA II Gender Differences Sub-Study

Background: In ROMA II trials we ascertained that the reloading of statin, in stable patients on chronic statin therapy, decreases the incidence of periprocedural myocardial infarction (PMI) comparing with the standard treatment. Objectives: We sought to investigate the impact of gender difference on the efficacy of statin reloading to reduce the PMI. Methods: In ROMA II trial, patients who underwent elective PCI, were randomized to receive a pre-procedural loading dose of statin or the standard treatment. In this sub-analysis patients were divided in two groups according to gender differences. Results: Twelve and 24-hours post-PCI Troponin T (TnT) elevation > 5 x 99th percentile URL frequency didn’t show significant differences between men and female treated with a reloading dose of statin (respectively, at 12-h: 11.3% vs 8.3%; p = 0.22 and at 24-h: 16.7% vs 17.9%; p = 0.97). At 12-months follow-up the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) did not show significant differences between men and female treated with reloading dose of statin (respectively, 5% vs 4%, p = 0.62, Log-rank test). Conclusions: PMI is not correlated with sex in stable patients reloaded with statin.