Design and rationale of a study in Asia of atorvastatin pretreatment in patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndromes

Background: Studies in Western populations have shown the benefits of pretreatment with atorvastatin in preventing cardiovascular events in patients, including those with acute coronary syndromes (ACS), undergoing percutaneous coronary intervention (PCI). However, data concerning the value of such therapy in Asian patients are limited. The primary objective of the present study is to evaluate the efficacy of atorvastatin in reducing cardiovascular outcomes in Asian patients with non-ST-segment elevation (NSTE)-ACS following hospital admission for early PCI (within 72 h of the onset of symptoms). Secondary objectives are to assess the effects of atorvastatin on cardiac biomarker levels, and the safety and tolerability profile of atorvastatin. Methods: This study is a prospective, multicenter, open-label trial designed to enroll 350 statin-naïve patients with NSTE-ACS scheduled for PCI in China and the Republic of Korea. Patients are randomized to either usual care or atorvastatin treatment groups, with patients in both treatment groups receiving usual care including atorvastatin 40 mg/day for 30 days post-PCI. Patients in the atorvastatin group receive additional doses of atorvastatin 80 mg at 12 h pre-PCI and 40 mg at 2 h pre-PCI. The primary end point is the incidence of major adverse cardiac events (death, myocardial infarction, and target vessel revascularization) at 30 days post-PCI. Conclusions: The present study will provide valuable insights into whether the benefits of atorvastatin pretreatment extend to Asian patients with ACS undergoing interventions. Enhanced treatment of these patients will be an important contribution towards alleviating the increasing burden of cardiovascular disease in Asian countries.