Drug delivery at the aortic valve tissues of healthy domestic pigs with a Paclitaxel-eluting valvuloplasty balloon.

Background: Restenosis occurs invariably within 1 year following balloon valvulopasty in aortic valve stenosis. The mechanism of restenosis seems to involve a dynamic cellular component that could be a target for drug inhibition. We investigated the feasibility of local drug delivery at the aortic valve tissues of healthy pigs with a paclitaxel-eluting balloon. Methods:Aorticvalvuloplasty was performedineight anesthetized domestic pigs usingpaclitaxel-eluting balloons (3 μg/mm 2 balloon surface area). They were assigned to two or four times 15-second balloon inflations and were sacrificed 30 minutes after final balloon inflation. Results: The aortic annulus to balloon diameter ratio was 1.15 ± 0.07. The mean paclitaxel concentration in the aortic valve leaflets was 0.91 ± 1.36 μg/mL (0.34 ± 0.05 μg/mL in the two-inflation group, 1.48 ± 1.86 μg/mL in the four-inflation group, P = 0.23). The percentage of the total paclitaxel dose recovered in the aortic valve leaflets was 18 ± 11 −6 %( 13± 6 −6 % and 25 ± 14 −6 % in the two- and four-inflation group, P = 0.16). Conclusion: Local drug delivery at the aortic valve leaflets of healthy pigs with a paclitaxel-eluting balloon is feasible and concentrations within the therapeutic window are detected 30 minutes after the procedure. The antirestenotic potential of this treatment should be studied. (J Interven Cardiol 2009;**:1–8)