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

Abstract

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.

Key words::

• Atorvastatin
• Acute coronary syndrome
• Advanced coronary artery disease

Transparency

Declaration of funding

This study has been financially supported by the Lazio Regional Section of the Italian National Association of Hospital Cardiologists (ANMCO), which is the scientific association of cardiologists working in public hospitals of the Italian National Health Service (www.anmco.it). All authors are active members of this scientific association.

The study was independently designed and conducted by the investigators and was not supported nor funded by any industry. All authors have contributed significantly to the preparation of the final report, have participated in the writing of the manuscript and approved the final version.

Declaration of financial/other relationships

All authors have neither financial relationships nor conflicts of interest to disclose in relation to this study. Peer reviewers may receive honoraria for their review work for CMRO. The peer reviewers have disclosed that they have no relevant financial relationships.

Acknowledgements

The investigators acknowledge the secretarial assistance during the study and in the preparation of the final report of Mrs Irene Di Pinto, whose work was entirely funded by the Lazio Regional Section of Italian National Association of Hospital Cardiologists (ANMCO).

The results of the study have been partially presented as an abstract at the European Congress of Cardiology 2008, Munich, Germany

Steering committee of the study

F. Colivicchi, M. Tubaro, M. Santini, “S. Filippo Neri” Hospital, Rome, Italy; A. Genovesi Ebert, “Spedali Riuniti” Hospital, Livorno, Italy

Investigators

F. Colivicchi; M. Tubaro; D. Mocini; M. Santini, “S. Filippo Neri” Hospital, Rome, Italy; G. Melina; S. Strano, Sapienza University, Rome, Italy; M.Uguccioni, “CTO-Alesini” Hospital, Rome, Italy.

End point committee

P. Buccolini, “S. Feliciano” Clinic, Rome Italy; F. Ammirati, “G.B. Grassi” Hospital, Ostia, Rome, Italy

Study safety and efficacy monitor

D. Melina, Catholic University, Rome, Italy