
    imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator
  
['transcatheter aortic valve replacement']
['rivaroxaban (xarelto, bay59-7939)', 'acetylsalicylic acid (asa)', 'clopidogrel', 'rivaroxaban (xarelto, bay59-7939)', 'vitamin k antagonist (vka)']

        Inclusion Criteria:

          -  Successful TAVR (Transcatheter Aortic Valve Replacement) of an aortic valve stenosis
             (either native or valve-in-valve)

               -  By iliofemoral or subclavian access

               -  With any approved/marketed device

        Exclusion Criteria:

          -  Atrial fibrillation (AF), current or previous, with an ongoing indication for oral
             anticoagulant treatment

          -  Any other indication for continued treatment with any oral anticoagulant (OAC)

          -  Known bleeding diathesis (such as but not limited to active internal bleeding,
             clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin
             level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history
             of intracranial hemorrhage or subdural hematoma)

          -  Any ongoing absolute indication for dual antiplatelet therapy (DAPT) at time of
             screening that is unrelated to the TAVR procedure

          -  Clinically overt stroke within the last 3 months

          -  Planned coronary or vascular intervention or major surgery

          -  Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR
             unresolved acute kidney injury with renal dysfunction stage 2 or higher

          -  Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic
             disease associated with coagulopathy
      