Key result
Ramipril fails to slow aortic dilatation progression vs. placebo in bicuspid aortic valve disease.
Why the study?
No medical therapy currently exists to delay or prevent ascending aorta dilatation in patients with bicuspid aortic valve disease, and the effect of renin–angiotensin system inhibition on aortic dilatation in these patients is unknown.
Does ramipril reduce the rate of ascending aorta dilatation in patients with bicuspid aortic valve disease and moderate or severe aortic stenosis?
RCT (n=34)
Double-blind
randomised
Does ramipril reduce the rate of ascending aorta dilatation in patients with bicuspid aortic valve disease and moderate or severe aortic stenosis?
In a small sub-study of patients with bicuspid aortic valve and aortic stenosis, ramipril did not significantly alter the rate of aortic dilatation over one year compared to placebo.
Ramipril showed no effect on AA dilatation in this small BAV sub-study; leaves open whether longer RAS inhibition alters progression in adequately powered trials.
Introduction Dilation of the ascending aorta (AA) is associated with bicuspid aortic valve (BAV) disease and currently no medical therapy exists to delay or prevent AA dilatation in these patients. Inhibition of the renin–angiotensin system (RAS) appears toslow the rate of aortic dilatation in Marfan syndrome, but the effect on the aorta in BAV disease is unknown.We hypothesised that inhibition of the RAS in patients with BAV may reduce the rate of AA dilatation. Methods This was a sub study of the RIAS trial (Ramipril In Aortic Stenosis), including only those subjects with BAV. RIAS was a randomised double blind, placebo controlled trial in which patients with moderate or severe aortic stenosis were randomised to ramipril 10 mg or placebo for one year. CMR scanning at 1.5 T was carried out at baseline and 12 months for assessment of aortic dimensions and valve morphology. Dimensions of the aorta were measured by a single observer (blinded to treatment allocation) at the aortic annulus, sinuses of Valsalva, sinotubular junction and mid-ascending aorta at the level of the pulmonary artery. Any change in dimensions from baseline in each group were noted and between group comparisons were made using dummy variable regression analysis. Results 34 patients with BAV were recruited and completed the trial (18 ramipril, 16 placebo). (See Table 1 for patient characteristics). At 12 months, there were no significant differences from baseline in AA measurements in either group, nor between the ramipril and placebo groups (See Table 2). There was a consistent small increase in all dimensions in the placebo group compared to the ramipril group which was not statistically significant. Conclusions Ramipril did not significantly alter the rate of progression of aortic dilatation at one year in this small study of patients with BAV. Our study was limited by a small number of patients and only one year follow up. Larger studies of RAS inhibition in this population with longer follow up may be warranted.
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Loudon et al. (2014) conducted an RCT in Bicuspid aortic valve disease with moderate or severe aortic stenosis (n=34). Ramipril vs. Placebo was evaluated on Change in dimensions of the ascending aorta from baseline. Ramipril 10 mg did not significantly alter the rate of progression of aortic dilatation at 12 months compared to placebo in 34 patients with bicuspid aortic valve disease.
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