A Randomized Trial of Intensive Lipid-Lowering Therapy in Calcific Aortic Stenosis
S. Joanna Cowell, B.M., David E. Newby, M.D., Robin J. Prescott, Ph.D., Peter Bloomfield, M.D., John Reid, M.B., Ch.B., David B. Northridge, M.D., Nicholas A. Boon, M.D., for the Scottish Aortic Stenosis and Lipid Lowering Trial, Impact on Regression (SALTIRE) Investigators
Background Calcific aortic stenosis has many characteristicsin common with atherosclerosis, including hypercholesterolemia.We hypothesized that intensive lipid-lowering therapy wouldhalt the progression of calcific aortic stenosis or induce itsregression.
Methods In this double-blind, placebo-controlled trial, patientswith calcific aortic stenosis were randomly assigned to receiveeither 80 mg of atorvastatin daily or a matched placebo. Aortic-valvestenosis and calcification were assessed with the use of Dopplerechocardiography and helical computed tomography, respectively.The primary end points were change in aortic-jet velocity andaortic-valve calcium score.
Results Seventy-seven patients were assigned to atorvastatinand 78 to placebo, with a median follow-up of 25 months (range,7 to 36). Serum low-density lipoprotein cholesterol concentrationsremained at 130±30 mg per deciliter in the placebo groupand fell to 63±23 mg per deciliter in the atorvastatingroup (P<0.001). Increases in aortic-jet velocity were 0.199±0.210m per second per year in the atorvastatin group and 0.203±0.208m per second per year in the placebo group (P=0.95; adjustedmean difference, 0.002; 95 percent confidence interval, 0.066to 0.070 m per second per year). Progression in valvular calcificationwas 22.3±21.0 percent per year in the atorvastatin group,and 21.7±19.8 percent per year in the placebo group (P=0.93;ratio of post-treatment aortic-valve calcium score, 0.998; 95percent confidence interval, 0.947 to 1.050).
Conclusions Intensive lipid-lowering therapy does not halt theprogression of calcific aortic stenosis or induce its regression.This study cannot exclude a small reduction in the rate of diseaseprogression or a significant reduction in major clinical endpoints. Long-term, large-scale, randomized, controlled trialsare needed to establish the role of statin therapy in patientswith calcific aortic stenosis.
Source Information
From the Department of Cardiology, Royal Infirmary, Edinburgh (S.J.C., D.E.N., P.B., N.A.B.); Public Health Sciences, University of Edinburgh Medical School, Edinburgh (R.J.P.); the Department of Radiology, Borders General Hospital, Melrose, Roxburghshire, United Kingdom (J.R.); and the Department of Cardiology, Western General Hospital, Edinburgh (D.B.N.).
Address reprint requests to Dr. Newby at the Department of Cardiology, Royal Infirmary, Old Dalkeith Rd., Little France, Edinburgh EH16 4SU, United Kingdom, or at d.e.newby{at}ed.ac.uk.
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