Abstract 15520: Use of the Novel Biomarker-Based ABC-Bleeding Risk Score Over Time in Atrial Fibrillation: Insights From the ARISTOTLE Trial
Introduction: A novel biomarker-based risk score for major bleeding during oral anticoagulation was recently developed to improve outcomes in patients with atrial fibrillation (AF). This ABC-bleeding score (Age, Biomarkers [GDF-15, hemoglobin (Hb), and cardiac troponin (cTnT)], and Clinical history of prior bleeding) performed better than the HAS-BLED in both the internal (n=14,537) and the external validation cohorts (n= 8,468). We now evaluated the performance of the ABC-bleeding score over time by re-analyzing biomarkers after two months.
Methods: The ARISTOTLE trial compared apixaban vs warfarin in AF patients followed for a median of 1.8 years. Safety endpoint was ISTH major bleeding. In the biomarker substudy, 4,780 patients provided plasma samples both at entry and after 2 months. GDF-15 and cTnT were measured with Immunoassays. Hb measurements were performed at 3 month within the main trial. C indices and calibration plots were used to evaluate the score at baseline and at 2 months.
Results: Changes in biomarker levels after 2 months were small (median GDF-15 +3.6%; Hb -1%; cTnT +2.8%) and intraindividual correlation was high (all ≥0.80). Based on 8,189 person-years of follow-up and 190 adjudicated major bleeding events after the 2 months visit, the ABC-bleeding score at 2 months achieved a C index of 0.66 (95% CI 0.62, 0.70) as compared to 0.66 (0.62, 0.70) at baseline. The ABC-bleeding score at 2 months was well calibrated according to predefined risk classes (Fig). Repeated measurements of biomarkers did not provide incremental information to the risk score at baseline.
Conclusions: The biomarker-based ABC-bleeding score was well calibrated and showed similar predictive ability when reevaluated after 2 months. These results support that the ABC-bleeding risk score provide reliable prognostic information at different time-points. Whether biomarker retesting at a later time point would add additional prognostic information requires further investigation.
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- © 2016 by American Heart Association, Inc.