The representativeness of direct oral anticoagulant clinical trials to hospitalized patients with atrial fibrillation

Trials of the direct oral anticoagulants (DOACs) dabigatran, rivaroxaban and apixaban provide the basis for prescribing for the prevention of stroke and systemic embolism in atrial fibrillation (AF). The objective of this study was to assess the representativeness of the three pivotal DOAC randomized controlled trials of dabigatran, rivaroxaban and apixaban for unselected hospitalized patients with AF. A cross-sectional study was undertaken. All patients discharged with AF between 2012 and 2015 from a large public hospital network in Melbourne, Australia, were identified. Inclusion and exclusion criteria from the DOAC trials were applied. The proportions of hospitalized patients with AF who would have been eligible for the dabigatran (RE-LY), rivaroxaban (ROCKET-AF) and apixaban (ARISTOTLE) trials were estimated, as was pooled eligibility for all three trials. Characteristics of eligible and ineligible patients were compared. For the 4734 patients, application of the inclusion and exclusion criteria resulted in 60.5, 52.6 and 35.8% eligibility for the trials of apixaban, dabigatran and rivaroxaban, respectively. Pooled eligibility across all three trials demonstrated that 33.4% of the patients would have been eligible for all three trials but 36.7% ineligible for any trial. Ineligible patients who met exclusion criteria were older and experienced more comorbidities. The apixaban and dabigatran trials may be the most representative of hospitalized patients with AF. The DOAC trial results can readily be extrapolated to, and guide prescribing for, at least two thirds of patients discharged from a large metropolitan health service in Australia.