Moreover , no differences were observed in the occurrence of the secondary endpoint at 12 months ( 5.3 % vs. 4.0 % , difference : 1.2 % ; 95 % CI : -1.0 to 3.4 ; p = 0.273 ) and between 12 and 24 months ( 1.5 % vs. 2.2 % , difference : -0.7 % ; 95 % CI : -2.1 to 0.6 ; p = 0.289 ) .