Full-dose atorvastatin versus conventional medical therapy after non-ST-elevation acute myocardial infarction in patients with advanced non-revascularisable coronary artery disease

Aims: This study tested the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation. Methods and results: The study was an open-label, randomised, controlled, blinded end-point classification trial, employing the PROBE (Prospective Open Treatment and Blinded End Point Evaluation) design. A total of 290 patients (mean age 74.6 +/- 9.6 years) with NSTE-AMI and angiographic evidence of severe and diffuse CAD, not amenable to revascularisation by either coronary surgery or angioplasty, were randomised to atorvastatin 80 mg/day (n = 144) or conventional medical treatment (n = 146). A primary end point event (combination of cardiovascular death, non-fatal acute myocardial reinfarction and disabling stroke within 12 months of randomisation) occurred in 16.0% of patients treated with atorvastatin 80 mg/day and in 26.7% of patients receiving conventional treatment (HR 0.56; 95% CI 0.33-0.93, p = 0.027). The study was not blinded. Consequently, a bias in the assessment of clinical outcome cannot be completely excluded. Conclusions: In conclusion, when compared with a conventional treatment strategy, full-dose therapy with atorvastatin 80 mg/day provides greater protection against ischaemic recurrences after NSTE-AMI in patients with severe, diffuse, non-revascularisable CAD.