Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI (ROSUVA-30)

Effectiveness and Safety of Low-dose vs. High-dose Rosuvastatin on Long-term Cardiovascular Events in Korean Patients After Percutaneous Coronary Intervention: 30-month, Prospective, Single-center, Randomized Trial

This study is a prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary intervention with the newer drug-eluting stent.

With the development of the newer generation drug-eluting stents, percutaneous coronary intervention (PCI) has been a feasible treatment for patient with coronary artery disease. However, stent failures including in-stent restenosis and stent thrombosis have been still problematic. Moreover, neoatherosclerosis, which is the atherosclerotic process developed in the neointima within the implanted stent, has been reported to be associated with neoatherosclerotic plaque rupture and contribute to the development of acute coronary syndrome in patients after drug-eluting stent (DES) implantation. In this perspective, recent AHA/ACC and ESC guidelines recommend the high-dose(intensity) statin therapy for patients performed PCI. However, the efficacy of the high-dose(intensity) statin therapy on cardiovascular outcomes is still controversial. Several meta-analysis failed to show the benefit of the high-dose(intensity) statin therapy to reduce the mortality. Moreover, clear evidence for the benefits of such high-dose(intensity) statin therapy has no yet been demonstrated in East Asian patients. This trial was designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after PCI in the era of the newer generation DES era.

Rosuvastatin Calcium, Percutaneous Coronary Intervention, Drug-Eluting Stents, Patient Outcome Assessment, Biomarkers, Hyperlipidemias, Dyslipidemias, Atherosclerosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Anticholesteremic Agents, Hypolipidemic Agents, Lipid Regulating Agents

Patients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention

Patients are treated with Rosuvastatin 20mg/day for 30 months after percutaneous coronary intervention

The cumulative incidences of the composite events of cardiac death, myocardial infarction, and repeat revascularization

The cumulative incidences of all-cause death for 30 months after percutaneous coronary intervention with drug-eluting stent

The cumulative incidences of cardiac death for 30 months after percutaneous coronary intervention with drug-eluting stent

The cumulative incidences of non-fatal myocardial infarction for 30 months after percutaneous coronary intervention with drug-eluting stent

The cumulative incidences of any repeat coronary revascularization for 30 months after percutaneous coronary intervention with drug-eluting stent

The cumulative incidences of stent thrombosis categorized by ARC criteria for 30 months after percutaneous coronary intervention with drug-eluting stent

The percentage of the participants who reached the LDL-C level of <70mg/dL after the treatment for 6 months.

The percent changes of serum level of other biomarkers from baseline to to 6 months of treatment and thereafter

Inclusion Criteria: Patients underwent percutaneous coronary intervention with drug-eluting stent; Exclusion Criteria: Taking other drugs which can influence the lipid profile (eg. Niacin, Fibrates; Serum creatinine level > 2.0 mg/dL Serum aspartate transaminase > 3 times upper limit of normal Serum alanine transaminase > 3 times upper limit of normal Having anaphylactic reaction for Rosuvastatin; Having the other contraindications for Rosuvastatin; Having plan to be pregnant; Having life expectancy less than 1 year