ASTRONOMER Finds No Benefit of Rosuvastatin in Aortic Valvular Stenosis

January 4, 2010—Kwan Leung Chan, MD, et al have published findings from the ASTRONOMER (Aortic Stenosis Progression Observation: Measuring Effects of Rosuvastatin) trial that sought to assess the effect of cholesterol lowering with rosuvastatin (Crestor, AstraZeneca Pharmaceuticals LP, Wilmington, DE) on the progress of aortic valvular stenosis. The investigators noted that aortic valvular stenosis is an active process with similarities to atherosclerosis. The findings were published online ahead of print in Circulation. The University of Ottawa Heart Institute and AstraZeneca Canada (Mississauga, ON) sponsored the study, which was conducted in Canada.

As detailed in Circulation, ASTRONOMER was a randomized, double-blind, placebo-controlled trial in asymptomatic patients with mild to moderate aortic stenosis and no clinical indications for cholesterol lowering. The patients were randomized to receive either 40 mg daily of rosuvastatin, or placebo. A total of 269 patients were randomized: 134 patients to rosuvastatin and 135 patients to placebo. Annual echocardiograms were performed to assess aortic stenosis progression, which was the primary outcome; the median follow-up was 3.5 years. The peak aortic stenosis gradient increased in patients receiving rosuvastatin from a baseline of 40.8 ± 11.1 to 57.8 ± 22.7 mm Hg at the end of follow-up, and in patients with placebo from 41.6 ± 10.9 mm Hg at baseline to 54.8 ± 19.8 mm Hg at the end of follow-up. The annualized increase in the peak aortic stenosis gradient was 6.3 ± 6.9 mm Hg in the rosuvastatin group and 6.1 ± 8.2 mm Hg in the placebo group (P = .83). Treatment with rosuvastatin was not associated with a reduction in aortic stenosis progression in any of the predefined subgroups, the investigators reported.

The investigators concluded that in patients with mild to moderate aortic stenosis, cholesterol lowering with 40 mg of rosuvastatin did not reduce the progression of the disease; therefore, statins should not be used for the sole purpose of reducing the progression of aortic valvular stenosis.