Abstract
Edoxaban is an oral factor Xa inhibitor anticoagulant with 50% renal clearance, and proven efficacy and safety in patients (pts) with atrial fibrillation (AF). The post-authorisation, observational, ETNA-AF-Europe registry (NCT02944019) assessed the risks and benefits of edoxaban in pts with AF from 10 European countries.
Evaluate baseline characteristics and event rates in pts categorised by creatinine clearance (CrCl) at 1-year follow-up of the ETNA-AF-Europe registry.
In this analysis, pts were divided into three groups according to CrCl: ≤50 ml/min (I), 50–80 mL/min (II) and ≥80 mL/min (III) (calculated using Cockcroft-Gault). Outcomes were descriptively analysed.
Pts with the lowest CrCl (Group I) were mostly females, and had a higher mean age, lower body weight, higher stroke and bleeding risk scores and were considered more frail than those with higher CrCl (Groups II and III) (Table). Group I experienced higher rates of stroke or SEE, major or CRNM bleeding, cardiovascular death, and had a higher total mortality (Figure). Rates of intracranial haemorrhage (ICH) and haemorrhagic stroke (intracerebral and subarachnoid haemorrhage) were low and similar in pts across the range of CrCl.
Those with lower CrCl had more comorbidities and higher event rates than those with higher CrCl, with the exception of ICH and haemorrhagic stroke. A steep rise in the proportion of pts perceived as frail and in overall mortality in the lowest renal function tertile, raises the question whether low renal function is a determinant or a correlate of mortality.
Baseline characteristics
| n (%) or mean ± SD | ETNA-AF-Europe | CrCl ≤50 mL/min | CrCl >50, <80 mL/min | CrCl ≥80 mL/min |
|---|---|---|---|---|
| Overall | (Group 1) | (Group 2) | (Group 3) | |
| Patients | 13092 (100.0) | 2394 (21.0) | 4876 (42.8) | 4112 (36.1) |
| Male | 7430 (56.8) | 932 (38.9) | 2651 (54.4) | 2820 (68.6) |
| Age, years | 73.6±9.5 | 81.7±6.4 | 75.7±6.8 | 66.7±9.0 |
| Weight, kg | 81.0±17.3 | 68.5±12.6 | 77.0±12.7 | 92.2±17.5 |
| CrCl±CG, mL/min | 74.3±30.4 | 39.6±7.5 | 64.8±8.4 | 105.6±25.6 |
| CHA2DS2-VASc | 3.1±1.4 | 4.0±1.2 | 3.3±1.3 | 2.4±1.3 |
| Modified HAS-BLED | 2.5±1.1 | 3.0±1.0 | 2.7±1.1 | 2.2±1.1 |
| Frailty | 1392 (10.6) | 666 (27.8) | 506 (10.4) | 157 (3.8) |
| Paroxysmal AF | 7039 (53.9) | 1153 (48.3) | 2576 (52.9) | 2271 (55.3) |
| Persistent AF | 3159 (24.2) | 546 (22.9) | 1188 (24.4) | 1102 (26.8) |
| Long-standing persistent & permanent AF | 2864 (21.9) | 690 (28.9) | 1102 (22.6) | 732 (17.8) |
| n (%) or mean ± SD | ETNA-AF-Europe | CrCl ≤50 mL/min | CrCl >50, <80 mL/min | CrCl ≥80 mL/min |
|---|---|---|---|---|
| Overall | (Group 1) | (Group 2) | (Group 3) | |
| Patients | 13092 (100.0) | 2394 (21.0) | 4876 (42.8) | 4112 (36.1) |
| Male | 7430 (56.8) | 932 (38.9) | 2651 (54.4) | 2820 (68.6) |
| Age, years | 73.6±9.5 | 81.7±6.4 | 75.7±6.8 | 66.7±9.0 |
| Weight, kg | 81.0±17.3 | 68.5±12.6 | 77.0±12.7 | 92.2±17.5 |
| CrCl±CG, mL/min | 74.3±30.4 | 39.6±7.5 | 64.8±8.4 | 105.6±25.6 |
| CHA2DS2-VASc | 3.1±1.4 | 4.0±1.2 | 3.3±1.3 | 2.4±1.3 |
| Modified HAS-BLED | 2.5±1.1 | 3.0±1.0 | 2.7±1.1 | 2.2±1.1 |
| Frailty | 1392 (10.6) | 666 (27.8) | 506 (10.4) | 157 (3.8) |
| Paroxysmal AF | 7039 (53.9) | 1153 (48.3) | 2576 (52.9) | 2271 (55.3) |
| Persistent AF | 3159 (24.2) | 546 (22.9) | 1188 (24.4) | 1102 (26.8) |
| Long-standing persistent & permanent AF | 2864 (21.9) | 690 (28.9) | 1102 (22.6) | 732 (17.8) |
*Frailty reported as perceived by the investigator. AF, atrial fibrillation; CG, Cockcroft-Gault equation; CrCl, creatinine clearance.
Type of funding source: Private company. Main funding source(s): Daiichi Sankyo Europe GmbH, Munich, Germany
