Your choice for ageing
patients with NVAF

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Real-world evidence reinforces LIXIANA® as your DOAC of choice for ageing patients with NVAF1,2

Data from a 1-year snapshot analysis of an ongoing observational study in 12,574 patients with NVAF (ETNA-AF* Europe),1 treated with once-daily LIXIANA® (edoxaban), reinforced the findings of the pivotal phase 3 study (ENGAGE-AF** European Cohort).2,3

ETNA-AF supports the efficacy and safety profile of LIXIANA® in routine clinical practice.

Lower incidence of major bleeding and major GI bleeding

than in the pivotal phase 3 study†1,2

Lower incidence of stroke/SEE

than in the pivotal phase 3 study††1,2

Simple and convenient dosing, once daily, with or without food4

For illustration only, trials are not directly comparable

In patients with NVAF and high CrCl, there is a trend towards decreasing efficacy with increasing CrCl for edoxaban vs. well-managed warfarin, therefore careful evaluation of thromboembolic and bleeding risk is necessary before initiation.

ETNA-AF is the largest DOAC observational study of NVAF patients to date5

Key inclusion criteria:

Adult patients treated with LIXIANA® for NVAF according to the SmPC.5

Primary outcome measures:

Bleeding events; drug-related AEs; CV and all-cause mortality.5

Primary objective:

To assess the real-world safety and efficacy of LIXIANA® in NVAF patients in real-life clinical practice for up to 4 years.5

13,980 NVAF patients from 825 centres in 10 European countries enrolled5

ETNA-AF observational study design and baseline patient characteristics5

Study design
  • 13,638 NVAF patients received standard dose LIXIANA® (60 mg) or reduced dose LIXIANA® (30 mg)‡5
  • The mean patient age was 73.6 years‡5
Baseline characteristics

ETNA-AF – Europe 1-year analysis: baseline patient characteristics2

Results from a 1-year snapshot analysis of the baseline and first outcomes data of 12,574 patients (89.9% of enrolled patients) who completed the 1-year follow-up visit (mean follow-up: 348 days) presented at ESC.2

Baseline patient characteristics were comparable to those in the ENGAGE-AF clinical trial.2

Baseline characteristics according to dose

ETNA-AF – Europe 1-year analysis: baseline patient characteristics according to dose2

LIXIANA® in routine clinical practice:

ETNA-AF – Europe 1-year analysis1,2

Major bleeding

Patients with AF receiving LIXIANA® in routine clinical practice in ETNA-AF – Europe had a lower incidence of major bleeding than the European cohort of ENGAGE-AF.1,2

For illustration only, trials are not directly comparable.

Major GI bleeding

Patients with AF receiving LIXIANA® in routine clinical practice in ETNA-AF – Europe had numerically lower rates of major GI bleeding than the European cohort of ENGAGE-AF.1,2

For illustration only, trials are not directly comparable.

Intracranial haemorrhage

Patients with AF receiving LIXIANA® in routine clinical practice in ETNA-AF – Europe had a numerically lower incidence of intracranial haemorrhage to the European cohort of ENGAGE-AF.1,2

For illustration only, trials are not directly comparable.

Stroke/SEE

The incidence of stroke/SEE was lower in patients who received LIXIANA® in routine clinical practice in ETNA-AF – Europe than the European cohort of ENGAGE-AF.1,2

The highest incidence of stroke/SEE was observed in patients receiving a reduced dose of LIXIANA® 30 mg in ENGAGE-AF.1,2

For illustration only, trials are not directly comparable.

All-cause mortality

All-cause mortality was higher in patients receiving LIXIANA® 30 mg O.D. in

ETNA-AF – Europe vs. the European cohort of ENGAGE-AF.1,2

This would be consistent with this patient group also having a higher mean age (79.5 years vs. 75.6 years, respectively).1,2

For illustration only, trials are not directly comparable.

CV mortality

The CV mortality rate was lower in patients who received LIXIANA® in routine clinical practice in ETNA-AF than the European cohort of ENGAGE-AF.1,2

For illustration only, trials are not directly comparable.

Footnotes

* ETNA-AF (Edoxaban Treatment in Routine Clinical Practice for Patients With Nonvalvular Atrial Fibrillation).

** ENGAGE-AF (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation).

† High bleeding risk defined as a HAS-BLED score ≥4, intermediate risk defined as a score of 2–3. Low risk is defined as <2. Total mean calculated score was 2.5 in ETNA-AF (Europe) and 1.4 in ENGAGE-AF (European Cohort).

†† High stroke risk defined as CHA2DS2-VASc score ≥2 for men or ≥3 for women, intermediate risk defined as a score of 1 for men or 2 for women. Definition CHA2DS2-VASc score: Congestive heart failure, Hypertension, Age (≥65=1 point, ≥75=2 points), Diabetes, prior Stroke/Transient Ischaemic Attack (2 points), Vascular disease, and Sex category. Total mean calculated score was 3.1 in ETNA-AF (Europe) and 4.3 in ENGAGE-AF (European Cohort).

Ɨ Patients should receive LIXIANA® 30 mg if they have one or more of: moderate or severe renal impairment (CrCl 15–50 ml/min), low body weight (≤60 kg) or concomitant use of potent P-gp inhibitors (dronedarone, erythromycin, ketoconazole, ciclosporin).

ƗƗ Includes patients who were randomised to receive LIXIANA® 60 mg O.D., with patient-specific reduction to 30 mg O.D. Please note that in ENGAGE-AF, LIXIANA® dose was halved to 30 mg if any of the following were present at randomisation or during the study: estimated CrCl 30–50 ml/min, body weight ≤60 kg, concomitant use of dronedarone, verapamil, quinidine3 – note that these criteria differ to the criteria for dose reduction included in the LIXIANA® SmPC, which include patients with one or more of: moderate or severe renal impairment (CrCl 15–50 ml/min), body weight ≤60 kg, concomitant use of the P-gp inhibitors ciclosporin, dronedarone, erythromycin, or ketoconazole.4

§ Data extracted from European countries that participated in ENGAGE-AF: Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Kingdom.

§§ CrCl calculated using the Cockcroft–Gault equation.

| Patient-specific dose reductions from 60 mg to 30 mg LIXIANA® O.D. in ETNA-AF – Europe were based on recommendations in the SmPC, i.e. patients with one or more of: moderate or severe renal impairment (CrCI 15–50 ml/min), body weight ≤60 kg, concomitant use of the P-gp inhibitors ciclosporin, dronedarone, erythromycin, or ketoconazole.4

|| In ENGAGE-AF, LIXIANA® dose was halved to 30 mg if any of the following were present at randomisation or during the study: estimated CrCI 30–50 mL/min, body weight ≥60 kg, concomitant use of dronedarone, verapamil, quinidine3 – note that these criteria differ to the criteria for dose reduction included in the LIXIANA® SmPC.

Major bleeding is defined by the ISTH as fatal bleeding, symptomatic bleeding in a critical area or organ, or bleeding that either causes a fall in haemoglobin ≥1.24 mmol/L or leads to transfusion of two or more units of whole blood or red cells.

AE, adverse event; CrCl, creatinine clearance; CV, cardiovascular; DOAC, direct oral anticoagulant; GI, gastrointestinal; ISTH, International Society on Thrombosis and Haemostasis; NVAF, nonvalvular atrial fibrillation; O.D., once daily; P-gp, p-glycoprotein; SD, standard deviation; SEE, systemic embolic events; SmPC, summary of product characteristics.