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Comparison of events across bleeding scales in the ENGAGE AF-TIMI 48 trial

Circulation Oct 30, 2019

Bergmark BA, Kamphuisen PW, Wiviott SD, et al. - Since there exists insufficient data comparing the most often used bleeding scales within a single at-risk cohort of patients with atrial fibrillation (AF), therefore, researchers examined bleeding results as per the ISTH, TIMI, GUSTO, and BARC bleeding scales in the ENGAGE AF (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation)-TIMI 48 trial of edoxaban vs warfarin. In the ENGAGE AF-TIMI 48 trial, a comparison was performed between warfarin vs a higher (60/30 mg daily) or lower (30/15 mg daily) dose edoxaban regimen in 21,105 enrolled patients with AF at risk for stroke (CHADS2 ≥ 2), who were observed for 2.8 years. Comparing the most severe events in each scale, ISTH Major bleeding was identified as the most common (n = 1,289) followed by TIMI Major (n = 548), GUSTO Severe/Life-Threatening (n = 347), and BARC 3c+5 (n = 276). Across commonly used bleeding scales, the frequency of the most severe bleeding events differed nearly four-fold. As far as the relative safety of edoxaban vs warfarin was concerned, it tended to rise with greater severity of bleeding.
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