AIMS: The choice between initiating a non- @entity2067 antagonist oral anticoagulant (NOAC) and a @entity2067 antagonist (VKA) in @entity1 with @entity955 ( @entity955 ) may be challenging. To assist in this decision, we developed a risk score to identify @entity1 for whom a therapeutic benefit of NOACs over VKA is predicted. METHODS AND RESULTS: ENGAGE @entity955 -TIMI 48 was a randomized clinical trial of @entity14242 vs. @entity1229 in 21   105 @entity1 with @entity955 . Cox proportional hazard models identified factors associated with a serious net clinical outcome (NCO) of disabling @entity64 , life-threatening @entity548 , and all-cause mortality in VKA na  ve @entity1 from the @entity1229 arm. These were used to develop an integer risk score. Performance was assessed by C-indices and validation by bootstrapping. Kaplan-Meier analyses were stratified by three score categories and treatment arm. Over a median of 2.7 years, 457 NCO events occurred in 2898 @entity1 with a total @entity1 -time of 7549.5 years (6.05%/year). The risk prediction model (C   =   0.693) for the NCO was translated into a 17-point integer score, with annualized event rates for the low, intermediate, and high-risk categories in the @entity1229 arm of 3.5%, 9.9%, and 20.8%, respectively. Therapeutic benefit of higher- and lower-dose @entity14242 over @entity1229 was demonstrated in the high- and intermediate-risk, with equal benefit in the low-risk categories (P-interaction 0.008 and 0.014, respectively). CONCLUSION: In VKA naive @entity1 with @entity955 , the TIMI- @entity955 score can assist in the prediction of a poor composite outcome and guide selection of anticoagulant therapy by identifying a differential clinical benefit with a NOAC or VKA.

A novel risk prediction score in @entity955 for a net clinical outcome from the ENGAGE XXXX -TIMI 48 randomized clinical trial.

@entity1 :: ('9606', 'Species') :: ['patients', 'person'] @entity64 :: ('MESH:D020521', 'Disease') :: ['stroke'] @entity548 :: ('MESH:D006470', 'Disease') :: ['bleeding'] @entity2067 :: ('MESH:D014812', 'Chemical') :: ['vitamin K'] @entity14242 :: ('MESH:C552171', 'Chemical') :: ['edoxaban'] @entity955 :: ('MESH:D001281', 'Disease') :: ['atrial fibrillation', 'AF'] @entity1229 :: ('MESH:D014859', 'Chemical') :: ['warfarin']
@entity955 :: (MESH:D001281,Disease) :: ['AF']
