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Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial.

著者 Bergmark BA , Kamphuisen PW , Wiviott SD , Ruff CT , Antman EM , Nordio F , Kuder JF , Mercuri MF , Lanz HJ , Braunwald E , Giugliano RP
Circulation.2019 Oct 10 ; ():.
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Numerous scales exist for classification of major bleeding events. There are limited data comparing the most commonly used bleeding scales within a single at-risk cohort of patients with atrial fibrillation (AF). Here we analyze bleeding outcomes according to 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. 21,105 patients with AF at risk for stroke (CHADS ≥2) were enrolled in the ENGAGE AF-TIMI 48 trial (NCT00781391) comparing warfarin to a higher (HDER; 60/30 mg daily) or lower (LDER; 30/15 mg daily) dose edoxaban regimen. Median follow-up was 2.8 years. Bleeding events occurring among on-treatment patients were examined. Annualized event rates were calculated by the ISTH, TIMI, GUSTO, and BARC scales and compared across treatment arms. Cox proportional hazards for a first bleeding event of each type were calculated for HDER vs warfarin and LDER vs warfarin. 10,311 total bleeding events were reported. Comparing the most severe events in each scale, ISTH Major bleeding was the most common (n=1,289) followed by TIMI Major (n=548), GUSTO Severe/Life-Threatening (n=347), and BARC 3c+5 (n=276). Lower bleeding risk with edoxaban as compared with warfarin was seen regardless of bleeding scale (HDER range: HR 0.47 [0.35-0.62] for BARC 3c+5 to HR 0.80 [0.71-0.91] for ISTH Major; LDER range: HR 0.32 [0.23-0.45] for BARC 3c+5 to HR 0.47 [0.41-0.55] for ISTH Major). Further, a gradient of more pronounced risk reduction with edoxaban was observed for with greater severity of first bleeding event (HDER: HR 0.47 [0.35-0.62] for BARC 3c+5 bleeds vs HR 0.86 [0.81-0.91] for any BARC bleed; LDER: HR 0.32 [0.23-0.45] for BARC 3c+5 bleeds vs HR 0.68 [0.63-0.72] for any BARC bleed). The direction of this trend was consistent for both gastrointestinal and non-gastrointestinal bleeding. Among patients with AF at risk for stroke, there was an approximately four-fold difference in the frequency of the most severe bleeding events across commonly used bleeding scales. Further, the relative safety of edoxaban as compared with warfarin tended to increase with greater severity of bleeding. URL: https://clinicaltrials.gov Unique Identifier: NCT00781391.
PMID: 31597460 [PubMed - as supplied by publisher]
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