Renal Function and 4‐Year Outcomes in Edoxaban‐Treated Patients: A Sub‐Analysis From the ETNA ‐ AF Europe Study

Figures

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  FIGURE 1. Patient flow diagram (full analysis set of ETNA‐AF Europe and full analysis set of patients considered in this sub‐analysis). *Missing n = 505 patients with missing dose data. **Seventy‐five patients with missing CKD stage data. Definition of CKD stages (eGFR, CKD‐EPI Formula): Stage 4: eGFR ≥ 15 to < 30 mL/min/1.73 m2, Stage 3: eGFR ≥ 30 to < 60 mL/min/1.73 m2, Stage 2: eGFR ≥ 60 to < 90 mL/min/1.73 m2, Stage 1: eGFR > 90 mL/min/1.73 m2. CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; SmPC, summary of product characteristics.

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  FIGURE 2. Non‐adjusted and adjusted HR comparing renal stages versus the reference stage (≥ 90 mL/min) for effectiveness outcomes of interest in patients from ETNA‐AF Europe 4‐year follow‐up on label‐recommended edoxaban dose (30 or 60 mg) (FAS, N = 9114). Hazard ratios were adjusted for age, sex, body weight and CHA2DS2‐VASc score and modified HAS‐BLED. Definition of CKD stages (eGFR, CKD‐EPI Formula): Stage 4: eGFR ≥ 15 to < 30 mL/min/1.73 m2, Stage 3: eGFR ≥ 30 to < 60 mL/min/1.73 m2, Stage 2: eGFR ≥ 60 to < 90 mL/min/1.73 m2, Stage 1: eGFR > 90 mL/min/1.73 m2. For categories with < 5 observations no HR, CIs and p‐values are provided. AF, atrial fibrillation; CI, confidence interval; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; FAS, full analysis set; HR, hazard ratio; NA, not assessable; SEE, systemic embolism event.

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  FIGURE 3. Non‐adjusted and adjusted HR comparing CKD Stages versus the reference Stage 1 (≥ 90 mL/min) for safety outcomes of interest in patients from ETNA‐AF Europe 4‐year follow‐up on label‐recommended edoxaban dose (30 or 60 mg; FAS, N = 9114). Hazard ratios were adjusted for age, sex, body weight and CHA2DS2‐VASc score and modified HAS‐BLED. Definition of CKD stages (eGFR, CKD‐EPI Formula): Stage 4: eGFR ≥ 15 to < 30 mL/min/1.73 m2, Stage 3: EGFR ≥ 30 to < 60 mL/min/1.73 m2, Stage 2: eGFR ≥ 60 to < 90 mL/min/1.73 m2, Stage 1: eGFR ≥ 90 mL/min/1.73 m2. Definition of CV‐death sensitivity: Death due to CV cause or bleeding, or if a stroke, TIA, SEE, PE, MI, VTE or major bleeding occurred within 30 days before death and the reason for death is unknown or missing. For categories with < 5 observations no HR and CIs are provided. CI, confidence interval; CKD, chronic kidney disease; CrCl, derived creatinine clearance; CV, cardiovascular; FAS, full analysis set; GI, gastrointestinal; HR, hazard ratio; ICH, intracranial haemorrhage; MI, myocardial infarction; NA, not assessable; PE, pulmonary embolism; TIA, transient ischemic attack; VTE, venous thromboembolism.