Comparison on long-term effects of atorvastatin or pravastatin combined with clopidogrel for patients undergoing coronary stenting: a randomized controlled trial

Abstract

To evaluate the long-term therapeutic effects of atorvastatin via cytochrome P450 (CYP)3A4 pathway or a non-CYP 3A4 pathway statin, pravastatin, combined with clopidogrel for the patients undergoing coronary stenting. Between February 2006 and March 2007, a total of 1275 patients undergoing successful coronary stenting were randomly assigned to receive atorvastatin 20 mg/d (n = 638) or pravastatin 20 mg/d (n = 637). All patients received standard clopidogrel therapy. The primary end point was cardiac and cerebral ischemic events at 12 months, defined as a composite of cardiac death, non-fatal myocardial infarction (MI) or stroke. The secondary end points were major adverse cardiac and cerebral events (MACCE), stent thrombosis and TIMI hemorrhagic events at 12 months. The baseline clinical characteristics, angiographic and PCI result were comparable between two groups. At 12 month follow-up, no significant difference was observed in cardiac and cerebral ischemic events between two groups (4.7% vs 5.5%, P > 0.05). Also no significant difference existed in rate of cardiac death (1.9% vs 2.5%, P > 0.05), non-fatal MI (0.5% vs 0.3% , P > 0.05), stroke (2.4% vs 2.7%, P > 0.05) and TVR (7.7% vs 5.5%, P > 0.05) between two groups. The rates of MACCE (12.4% vs 11.0%, P > 0.05), stent thrombosis (2.0% vs 2.5%, P > 0.05) and hemorrhagic events (13.0% vs 12.2%, P > 0. 05) were similar between two groups. The 12 month clinical outcomes were similar between patients receiving atorvastatin 20 mg/d or pravastatin 20 mg/d combined with clopidogrel after coronary stenting. It confirmed the efficacy and safety of the combination of clopidogrel with statins via different metabolic pathways.