Cumulative risk of the primary safety outcomes of life-threatening (including fatal) or disabling or major bleeding events [Bleeding Academic Research Consortium (BARC) 4, 3a, 3b, and 3c], as defined by the Valve Academic Research Consortium-2 (VARC-2) in the whole population (A) and according to the need (B, Stratum 1) or not (C, Stratum 2) for chronic oral anticoagulation in the safety population.