Objective: 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.
Methods: 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.
Results: 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.
Conclusion: 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.