Edoxaban Dose Adjustment and Age-Associated Outcomes in Patients With Atrial Fibrillation Post-Transcatheter Aortic Valve Replacement

Figures

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  Figure 1. Annualized On-Treatment Event Rates and Cox Regression of Endpoints Comparing Patients With and Without Edoxaban Dose Adjustment Criteria aHRs were only calculated for outcomes with ≥5 events in both groups. bSignificant P values were bolded. cThe ISTH definition was used. CV = cardiovascular; eDAC = edoxaban dose adjustment criteria; GI = gastrointestinal; ICH = intracranial hemorrhage; ISTH = International Society on Thrombosis and Haemostasis; NACE = net adverse clinical events; SEE = systemic embolic events.

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  Figure 2. Annualized On-Treatment Event Rates and Cox Regression of Endpoints Comparing Patients With vs Without Edoxaban Dose Adjustment Criteria (A) Patients aged <80 years and (B) patients aged ≥80 years. aHRs were only calculated for outcomes with ≥5 events in both groups. bSignificant P values were bolded. cThe ISTH definition was used. Abbreviations as in Figure 1.

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  Figure 3. Clinical Outcomes in Patients Receiving Edoxaban vs Vitamin K Antagonists Stratified by the Presence or Absence of Edoxaban Dose Adjustment Criteria (A) Aged <80 years and (B) aged ≥80 years. aHRs were only calculated for outcomes with ≥5 events in both groups. bThere were no statistically significant interactions assessing for a differential treatment effect comparing edoxaban vs VKA by eDAC (all P ≥ 0.20). cThe ISTH definition was used. VKA = vitamin K antagonist; other abbreviations as in Figure 1.

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  Central Illustration. Clinical Outcomes for Patients With Atrial Fibrillation After Successful Transcatheter Aortic Valve Replacement Stratified by Edoxaban Dose Adjustment Criteria and Age This post hoc, on-treatment analysis of the ENVISAGE-TAVI AF trial assessed whether the presence or absence of eDAC and age (<80 vs ≥ 80 years) affected clinical outcomes. Edoxaban dose was to be reduced from 60 mg to 30 mg in patients with AF who met ≥1 criteria: CrCl 15 to ≤50 mL/min; body weight ≤60 kg (not part of the U.S. label); concomitant P-glycoprotein inhibitors per local label (not part of the U.S. label). Edoxaban DAC also applied to patients on VKA. aHRs were only calculated for outcomes with ≥5 events in both groups. bThere were no statistically significant interactions assessing for a differential treatment effect comparing edoxaban vs VKA by eDAC (all P ≥ 0.20). cISTH definition was used. dSignificant P values were bolded. eData not shown. AF = atrial fibrillation; CrCl = creatinine clearance; CV = cardiovascular; eDAC = edoxaban dose adjustment criteria; GI = gastrointestinal; HR = hazard ratio; ISTH = International Society on Thrombosis and Haemostasis; NA = not applicable; TAVR = transcatheter…