We also evaluated the accuracy of the ORBIT, HAS-BLED, and ATRIA scores in an external AF population, ROCKET-AF, an international, randomized, double-blind, event-driven trial of 14 264 patients comparing rivaroxaban (20 mg daily) to dose-adjusted warfarin. Each score was recreated according to definitions given in the original derivation cohorts, using baseline values from the first trial visit, or from the first study visit in ORBIT-AF. Score components not collected in ROCKET-AF or ORBIT-AF were approximated using available data or contributed 0 points to the score if no approximation was available. The full list of definitions used to generate the scores in each dataset is provided in Supplementary materials online .
Statistical analysis was performed using SAS software (version 9.3, Cary, NC). All P-values presented are two sided, and P < 0.05 was considered to be statistically significant for all analyses. All ORBIT-AF study participants provided written informed consent prior to study entry. The ORBIT-AF Registry was approved by the Duke Institutional Review Board (IRB), and participating sites obtained approval from local IRBs as needed prior to entering patient data.
Statistical analysis was performed using SAS software (version 9.3, Cary, NC). All P-values presented are two sided, and P < 0.05 was considered to be statistically significant for all analyses. All ORBIT-AF study participants provided written informed consent prior to study entry. The ORBIT-AF Registry was approved by the Duke Institutional Review Board (IRB), and participating sites obtained approval from local IRBs as needed prior to entering patient data.
