A randomized trial of intensive lipid-lowering therapy in calcific aortic stenosis

Scottish Aortic Stenosis and Lipid Lowering Trial, Impact on Regression (SALTIRE) Investigators, S Joanna Cowell, David E Newby, Robin J Prescott, Peter Bloomfield, John Reid, David B Northridge, Nicholas A Boon

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)2389-2397
Number of pages9
JournalNew England Journal of Medicine
Volume352
Issue number23
DOIs
Publication statusPublished - 9 Jun 2005

Keywords

  • Anticholesteremic Agents
  • Aortic Valve
  • Aortic Valve Stenosis
  • Atorvastatin Calcium
  • Blood Flow Velocity
  • Calcinosis
  • Cholesterol, LDL
  • Disease Progression
  • Double-Blind Method
  • Echocardiography, Doppler
  • Heptanoic Acids
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pyrroles
  • Treatment Failure

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