ROsuvastatin LOading and Clinical Outcomes (ROLOCO) trial

Abstract

Background: Pre-procedural administration of statins has been found to be associated with reduced peri-procedural myocardial injury and infarction. Aim: The aim of the present study was to evaluate the effect of pre-procedural single high loading dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and composite of death or myocardial infarction from cardiovascular (CV) causes, target vessel revascularization (TVR), or stroke. Methods: Two hundred ninety nine statin-naive patients with stable ischemic heart disease (SIHD) and de novo lesions appropriate for PCI were randomized to rosuvastatin-treatment (n = 153) and to no-treatment (n = 146) groups. A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI. Four-year follow-up period was planned (long-term follow-up of previously published study). Results: A total of 290 (97%) patients (147 rosuvastatin and 143 no-treatment) completed the study. The median age was 62 years. Male was 70% and 18% of patients had diabetes and 43% had hypertension. Previous MI and PCI/CABG history were present in 27% and 39% of patients, respectively. The primary end-point of all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke was lower in the rosuvastatin group compared with the no-treatment group (10.2% vs. 22.4%, p = 0.005), driven by a reduction in TVR (6.1% vs. 13.3%, p = 0.039). ![Figure][1] Conclusion: Among patients with SIHD undergoing PCI, pre-procedural administration of single high loading dose of rosuvastatin was associated with a reduction in major adverse cardiac and cerebrovascular events (MACCE) at 4 years, driven primarily by a reduction in TVR. [1]: pending:yes