Impact of statins on progression of atherosclerosis: rationale and design of SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin versus AtorvastatiN)

Abstract

Background:

Previous imaging studies have demonstrated that the beneficial impact of high-dose statins on the progression of coronary atherosclerosis associates with their ability to lower levels of low-density lipoprotein cholesterol (LDL-C) and C-reactive protein (CRP) and to raise high-density lipoprotein cholesterol (HDL-C). The Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin versus AtorvastatiN (SATURN, NCT00620542) aims to compare the effects of high-dose atorvastatin and rosuvastatin on disease progression.

Methods:

A total of 1385 subjects with established coronary artery disease (CAD) on angiography were randomized to receive rosuvastatin 40 mg or atorvastatin 80 mg for 24 months. The primary efficacy parameter will be the nominal change in percent atheroma volume (PAV), determined by analysis of intravascular ultrasound (IVUS) images of matched coronary artery segments acquired at baseline and at 24-month follow-up. The effect of statin therapy on plasma lipids and inflammatory markers, and the incidence of clinical cardiovascular events will also be assessed. The study does not have the statistical power to directly compare the treatment groups with regard to clinical events.

Conclusion:

Serial IVUS has emerged as a sensitive imaging modality to assess the impact of treatments on arterial structure. In this study, IVUS will be used to determine whether high-dose statins have different effects on plaque progression.

Key words::

• Atherosclerosis
• Coronary artery disease
• Intravascular ultrasound
• Lipids
• Statins

Transparency

Declaration of funding

SATURN is sponsored by AstraZeneca Pharmaceuticals.

Declaration if financial/other interest

J.S.R. has disclosed that he is an employee of AstraZeneca Pharmaceuticals. S.J.N. has disclosed that he has received research support from AstraZeneca, Novartis, Eli Lilly, Anthera, LipoScience and Resverlogix and has received honoraria or been a consultant for Roche, AstraZeneca, Esperion, Abbott, Pfizer, Merck, Takeda, LipoScience, Omthera and Novo-Nordisk; M.B. has disclosed that she has no relevant financial relationships. C.B. has disclosed that she has received research support from Abbott, AstraZeneca, Bristol-Myers Squibb, diaDexus, GlaxoSmithKline, Kowa, Merck, Novartis, Roche, Sanofi-Synthelabo, Takeda, National Institutes of Health, American Diabetes Association, and American Heart Association, is a consultant for Abbott, Adnexus, Amylin, AstraZeneca, Bristol-Myers Squibb, Esperion, Genentech, GlaxoSmithKline, Idera Pharma, Kowa, Merck, Novartis, Omthera, Resverlogix, Roche, Sanofi-Synthelabo, and Takeda, and has received honoraria from Abbott, AstraZeneca, GlaxoSmithKline, Merck, Sanofi-Synthelabo and Takeda. P.B. has disclosed that he has received research support from Merck, Pfizer, Roche and AstraZeneca, is a consultant for AstraZeneca, CSL, Eli-Lilly, Merck, Novartis, Pfizer, Roche and Sanofi-Aventis and has received honoraria from Abbott, AstraZeneca, GlaxoSmithKline, Merck, Novartis, Pfizer and Roche. M.J.C. has disclosed that he has received research support from Merck and Pfizer and received honoraria from Merck, Roche and Kowa. R.E. has disclosed that he has served on the speakers’ bureau for Volcano and as a consultant or on an advisory board for Volcano. P.L. has disclosed that he is an unpaid consultant or involved in clinical trials for AstraZeneca, GlaxoSmithKline, Merck, Novartis, Pfizer, ProNova, and Sigma-Tau; and is a member of the scientific advisory boards for Carolus Therapeutics, Interleukin Genetics, and BIND Biosciences. S.E.N. has disclosed that he has received research support from AstraZeneca, Eli Lilly, Pfizer, Takeda, Sankyo, and Sanofi-Aventis. He has consulted for a number of pharmaceutical companies without financial compensation. All honoraria, consulting fees or any other payments from any for-profit entity are paid directly to charity, so that neither income nor any tax deduction is received.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

No editorial or writing assistance in the preparation of this article is to be declared.