Epistaxis versus Nicht-Epistaxis-Blutungen bei antikoagulierten Patienten mit Vorhofflimmern: Ergebnisse der ENGAGE AF-TIMI 48-Studie

BACKGROUND: Epistaxis is common with antithrombotic therapy and is often troublesome to patients, yet its frequency, severity, and outcomes are poorly characterized. METHODS AND RESULTS: Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) randomized 21 105 patients with atrial fibrillation and CHADS2 risk score ≥2 to higher-dose edoxaban regimen (60 mg daily, dose-reduced to 30 mg), lower-dose edoxaban regimen (30 mg, dose reduced to 15 mg, daily), or warfarin. Bleeds were adjudicated using International Society on Thrombosis and Haemostasis criteria. Patients with intracranial hemorrhage during follow-up were excluded; those with >1 bleeding event were categorized according to their most severe event. The safety cohort with interval censoring during drug interruption was analyzed. Proportions were compared using Pearson's chi-square test and treatment arms were compared using a Cox proportional hazards model. Among 5247 patients with a bleeding event, 1008 (19.2%) had epistaxis and 4239 (80.8%) had nonepistaxis bleeding. Epistaxis events were less severe than nonepistaxis bleeds (International Society on Thrombosis and Haemostasis major: 3.2% versus 20.7%; clinically relevant nonmajor: 64.7% versus 60.1%; minor: 32.1% versus 19.2%; P<0.001). Permanent drug discontinuation was similar following epistaxis versus nonepistaxis bleeding in patients with major (59.4% versus 53.6%; P=0.52) or clinically relevant nonmajor (32.5% versus 33.3%; P=0.70) bleeding but was significantly higher in patients with minor epistaxis versus other minor bleeds (33.3% versus 23.9%; P=0.001). Compared with warfarin, higher-dose edoxaban regimen had similar risk of epistaxis (hazard ratio [HR], 1.09 [95% CI, 0.95-1.26]), whereas lower-dose edoxaban regimen conferred reduced risk (HR, 0.73 [95% CI, 0.62-0.86]). CONCLUSIONS: Epistaxis was frequent, and despite being overall less severe than nonepistaxis bleeding, was associated with similar rates of anticoagulant discontinuation. Compared with warfarin, lower-dose edoxaban regimen reduced the risk of epistaxis by 27% whereas higher-dose edoxaban regimen had no effect. REGISTRATION: URL: https://clinicaltrials.gov; Unique Identifier: NCT00781391.

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In der ENGAGE AF-TIMI 48-Studie wurden 21 105 Patienten mit Vorhofflimmern und CHADS2 ≥ 2 zu hoch dosiertem Edoxaban (60/30 mg), niedrig dosiertem Edoxaban (30/15 mg) oder Warfarin randomisiert. Von 5 247 Patienten mit Blutung hatten 1 008 (19,2 %) eine Epistaxis; diese verlief insgesamt weniger schwer (ISTH-major 3,2 % vs. 20,7 %; p < 0,001). Gegenüber Warfarin zeigte höher dosiertes Edoxaban ein vergleichbares Epistaxisrisiko (HR 1,09), während niedriger dosiertes Edoxaban es um 27 % reduzierte (HR 0,73).

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