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Effects of Rosuvastatin on Progression of Stenosis in Adult Patients With Congenital Aortic Stenosis (PROCAS Trial)
Study Questions:
Does rosuvastatin slow or halt the progression of aortic stenosis (AS) in adult patients with congenital AS?
Methods:
The Progression of Stenosis in Adult Patients With Congenital Aortic Stenosis (PROCAS) multicenter, double-blind, placebo-controlled trial was performed. Patients (ages 18-45) with congenital AS were randomized to rosuvastatin 10 mg daily or placebo. The primary endpoint was progression of peak aortic valve velocity by echocardiogram, while secondary endpoints included changes in left ventricular mass, N-terminal pro-brain natriuretic peptide (NT-proBNP), and ascending aortic diameter.
Results:
A total of 63 patients, mean age 33 years, were enrolled and followed for a median of 2.4 years. Thirty patients received rosuvastatin, while 33 patients received placebo. The mean increase in peak velocity across the aortic valve was 0.05 ± 0.21 m/s annually in the rosuvastatin group, and 0.09 ± 0.24 m/s annually in the placebo group. There were no differences in changes in ascending aortic diameter or left ventricular mass between the two groups. For patients receiving rosuvastatin, the median baseline NT-proBNP level was 50 pg/ml and 21 pg/ml at follow-up (p = 0.638). For patients receiving placebo, the median NT-proBNP level increased from 40 pg/ml (interquartile range, 20-92) to 56 pg/ml (interquartile range, 26-130), p = 0.008.
Conclusions:
The authors concluded that lipid-lowering therapy with rosuvastatin does not reduce the progression of congenital AS in young, asymptomatic patients.
Perspective:
This small but well-designed study failed to show a benefit of rosuvastatin in slowing the progression of congenital AS over a reasonably short study period (median follow-up, 2.4 years). Enrollment in the study was not sufficient to achieve the 90 patients in each group calculated to provide sufficient power to demonstrate a difference between rosuvastatin and placebo. Nevertheless, the results of the study are consistent with those from previous studies performed in older patients with predominantly degenerative calcific AS, which failed to demonstrate delayed progression of AS with lipid-lowering agents. This study did show that NT-proBNP increased in the placebo group, but not in the rosuvastatin group. The clinical implications of this are unclear and deserve further study in a larger patient population.
Keywords: Fluorobenzenes, Follow-Up Studies, Pyrimidines, Calcinosis, Constriction, Pathologic, Sulfonamides, Puromycin, Natriuretic Peptide, Brain
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