Abstract
BASIK2 is a prospective, double-blind, randomized placebo-controlled trial investigating the effect of vitamin K2 (menaquinone-7;MK7) on imaging measurements of calcification in the bicuspid aortic valve (BAV) and calcific aortic valve stenosis (CAVS). BAV is associated with early development of CAVS. Pathophysiologic mechanisms are incompletely defined, and the only treatment available is valve replacement upon progression to severe symptomatic stenosis. Matrix Gla protein (MGP) inactivity is suggested to be involved in progression. Being a vitamin K dependent protein, supplementation with MK7 is a pharmacological option for activating MGP and intervening in the progression of CAVS. Forty-four subjects with BAV and mild–moderate CAVS will be included in the study, and baseline 18F-sodiumfluoride (18F-NaF) positron emission tomography (PET)/ magnetic resonance (MR) and computed tomography (CT) assessments will be performed. Thereafter, subjects will be randomized (1:1) to MK7 (360 mcg/day) or placebo. During an 18-month follow-up period, subjects will visit the hospital every 6 months, undergoing a second 18F-NaF PET/MR after 6 months and CT after 6 and 18 months. The primary endpoint is the change in PET/MR 18F-NaF uptake (6 months minus baseline) compared to this delta change in the placebo arm. The main secondary endpoints are changes in calcium score (CT), progression of the left ventricularremodeling response and CAVS severity (echocardiography). We will also examine the association between early calcification activity (PET) and later changes in calcium score (CT).
Highlights
A bicuspid aortic valve (BAV), an aortic valve consisting of two leaflets instead of three, is a common congenital abnormality, occurring in 13.7 per 1000 people in the general population, with a male predominance (3:1) [1,2]
computed tomography (CT) at baseline, 12 and Atorvastatin had no effect on the rate of change in Vmax or valvular calcification
Calcium score and mean pressure gradient progression in atorvastatin arm vs. placebo
Summary
A bicuspid aortic valve (BAV), an aortic valve consisting of two leaflets instead of three, is a common congenital abnormality, occurring in 13.7 per 1000 people in the general population, with a male predominance (3:1) [1,2]. BAV, valve replacement is usually indicated between the fourth and sixth decade, which is earlier than in tricuspid aortic valve (TAV) stenosis, in general [4] This suggests that, in patients with BAV, CAVS shows a more rapid rate of progression [5]. The principal objective of BASIK2 is to provide evidence to support the hypothesis that MK7 inhibits calcification activity in patients with BAV and CAVS. If successful, this would position this simple, safe and naturally occurring agent as the first effective treatment for aortic stenosis and set the foundations for larger phase 3 clinical outcome studies. To rapidly and efficiently test the efficacy of other potential therapies in phase 2 clinical trials
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