Abstract TP429: Arcadia versus Other Esus Trials: Comparison of Patient Characteristics

Abstract

Objective: We hypothesize that ESUS patients enrolled in the ARCADIA study are broadly representative and similar to those randomized in recent ESUS trials that returned negative results. Methods: This study is a qualitative comparison between characteristics of patients in NAVIGATE and RE-SPECT ESUS and those of patients enrolled up to this point in ARCADIA, an ongoing, investigator-initiated, NINDS-funded, multicenter, randomized trial of standard dose apixaban versus aspirin 81 mg daily among consented patients with ESUS and biomarker evidence of atrial cardiopathy. The patients from ARCADIA included all those consented, regardless of biomarker evidence of atrial cardiopathy. Inclusion and exclusion criteria, as well as detailed study protocols, have been previously reported. Results: Age and sex were similar in all three trials (see table). All trials had a similar proportion of white patients, but there were more black patients in ARCADIA and more Asian patients in RE-SPECT and NAVIGATE ESUS. More patients smoked (44%) in ARCADIA than in the other trials (17-20%). In all three trials strokes were clinically mild, with mean NIHSS scores and modified Rankin scores of 1. Further comparisons of patient characteristics are seen in the table below. Conclusions: Many of the characteristics of patients enrolled thus far in ARCADIA are similar to those of patients enrolled in the RE-SPECT ESUS and NAVIGATE ESUS trials, suggesting that the ARCADIA results will be highly generalizable. If positive, the ARCADIA trial results will highlight the importance of identifying a subgroup of ESUS patients likely to benefit from empiric treatment with anticoagulation, namely those with atrial cardiopathy. Important differences were seen between ARCADIA and the other trials, including proportions of patients who smoked and proportions of Black and Asian patients. These differences may be further analyzed upon completion of the trial.