SALTIRE
Trial question
What is the role of intensive lipid-lowering therapy in patients with calcific aortic stenosis?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 155
155 patients (47 female, 108 male).
Inclusion criteria: patients with calcific aortic stenosis.
Key exclusion criteria: active or chronic liver disease, a history of alcohol or drug abuse, severe mitral-valve stenosis, severe mitral or aortic regurgitation, LV dysfunction, a planned aortic-valve replacement, or intolerance of statins.
Interventions
N=77 atorvastatin (80 mg daily).
N=78 placebo (matching placebo once daily).
Primary outcome
Change in aortic-jet velocity
0.199 m/s/y
0.203 m/s/y
0.2 m/s/y
0.2 m/s/y
0.1 m/s/y
0.1 m/s/y
0.0 m/s/y
Atorvastatin
Placebo
No significant
difference ↔
No significant difference in change in aortic-jet velocity (0.199 m/s/y vs. 0.203 m/s/y; MD -0.002, 95% CI -0.07 to 0.07).
Secondary outcomes
No significant difference in progression in valvular calcification (22.3%/y vs. 21.7%/y; RR 0.998, 99% CI 0.95 to 1.05).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with calcific aortic stenosis, atorvastatin was not superior to placebo with respect to change in aortic-jet velocity.
Reference
Cowell SJ, Newby DE, Prescott RJ et al. A randomized trial of intensive lipid-lowering therapy in calcific aortic stenosis. N Engl J Med. 2005 Jun 9;352(23):2389-97.
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