Authors | Cowell SJ, Newby DE, Prescott RJ, Bloomfield P, Reid J, Northridge DB, Boon NA; Scottish Aortic Stenosis and Lipid Lowering Trial, Impact on Regression (SALTIRE) Investigators | |
Title | A randomized trial of intensive lipid-lowering therapy in calcific aortic stenosis | |
Full source | N Engl J Med. 2005 Jun 9;352(23):2389-97. | |
|
||
Abstract | BACKGROUND:
Calcific aortic stenosis has many characteristics in common with atherosclerosis,
including hypercholesterolemia. We hypothesized that intensive lipid-lowering
therapy would halt the progression of calcific aortic stenosis or induce
its regression. METHODS: In this double-blind, placebo-controlled trial,
patients with calcific aortic stenosis were randomly assigned to receive
either 80 mg of atorvastatin daily or a matched placebo. Aortic-valve stenosis
and calcification were assessed with the use of Doppler echocardiography
and helical computed tomography, respectively. The primary end points were
change in aortic-jet velocity and aortic-valve calcium score. RESULTS: Seventy-seven
patients were assigned to atorvastatin and 78 to placebo, with a median
follow-up of 25 months (range, 7 to 36). Serum low-density lipoprotein cholesterol
concentrations remained at 130+/-30 mg per deciliter in the placebo group
and fell to 63+/-23 mg per deciliter in the atorvastatin group (P<0.001).
Increases in aortic-jet velocity were 0.199+/-0.210 m per second per year
in the atorvastatin group and 0.203+/-0.208 m per second per year in the
placebo group (P=0.95; adjusted mean difference, 0.002; 95 percent confidence
interval, -0.066 to 0.070 m per second per year). Progression in valvular
calcification was 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; 95 percent confidence
interval, 0.947 to 1.050). CONCLUSIONS: Intensive lipid-lowering therapy
does not halt the progression of calcific aortic stenosis or induce its
regression. This study cannot exclude a small reduction in the rate of disease
progression or a significant reduction in major clinical end points. Long-term,
large-scale, randomized, controlled trials are needed to establish the role
of statin therapy in patients with calcific aortic stenosis |