Objectives: To evaluate the effect of intensive lipid-lowering treatment on coronary artery calcification in a substudy of a trial recruiting patients with calcific aortic stenosis.
Methods: In a double blind randomised controlled trial, 102 patients with calcific aortic stenosis and coronary artery calcification were randomly assigned by the minimisation technique to atorvastatin 80 mg daily or matched placebo. Coronary artery calcification was assessed annually by helical computed tomography.
Results: 48 patients were randomly assigned to atorvastatin and 54 to placebo with a median follow up of 24 months (interquartile range 24–30). Baseline characteristics and coronary artery calcium scores were similar in both groups. Atorvastatin reduced serum low density lipoprotein cholesterol (−53%, p < 0.001) and C reactive protein (−49%, p < 0.001) concentrations whereas there was no change with placebo (−7% and 17%, p > 0.95 for both). The rate of change in coronary artery calcification was 26%/year (0.234 (SE 0.037) log arbitrary units (AU)/year; n = 39) in the atorvastatin group and 18%/year (0.167 (SE 0.034) log AU/year; n = 49) in the placebo group, with a geometric mean difference of 7%/year (95% confidence interval −3% to 18%, p = 0.18). Serum low density lipoprotein concentrations were not correlated with the rate of progression of coronary calcification (r = 0.05, p = 0.62).
Conclusion: In contrast to previous observational studies, this randomised controlled trial has shown that, despite reducing systemic inflammation and halving serum low density lipoprotein cholesterol concentrations, statin treatment does not have a major effect on the rate of progression of coronary artery calcification.
- AU, arbitrary units
- BELLES, Beyond Endorsed Lipid Lowering with EBT Scanning
- CRP, C reactive protein
- LDL, low density lipoprotein
- SALTIRE, Scottish Aortic Stenosis Lipid Lowering Therapy, Impact on Regression
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Published Online First 31 January 2006
The SALTIRE trial was supported by a project grant from the British Heart Foundation (PG/2000/044) and an unrestricted educational grant from Pfizer (UK). Additional support was provided by the Wellcome Trust Clinical Research Facility, Edinburgh.
Competing interests: DEN and NAB hold unrestricted educational grant awards from Pfizer (UK) Ltd. DEN, DBN and NAB have undertaken paid consultancy and served on advisory boards for Pfizer (UK) Ltd.
Author contributions: ESH, SJC, JB and JR acquired the data. ESH and RP analysed the data. DEN, DBN and NAB conceived and designed the study. All authors contributed to the writing, revision and approval of the paper.
SALTIRE research team: Lorraine Anderson, Corrine Bell, Margaret Bland, Peter Bloomfield, Sharon Cameron, Nicholas Cruden, Jean Cunningham, Hayley Cuthbertson, Laura Flint, Margaret Henderson, Dawn Lyle, Maureen O’Donnell, Finney Paterson, Karen Paterson, Robin Prescott, Simon Robinson, Heather Spence, Julie Ticknal and Audrey White