This information is intended for healthcare professionals based in Ireland.

AVERROES

ELIQUIS® versus ASA (Acetylsalicylic Acid) to prevent stroke in patients with atrial fibrillation who have failed or are unsuitable for vitamin K antagonist treatment (AVERROES)1

In this double-blind study 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable were randomly assigned to receive ELIQUIS® (at a dose of 5 mg twice daily*) or ASA (81 to 324 mg per day**), to determine whether ELIQUIS® was superior. The mean follow up period was 1.1 years. The primary efficacy outcome was the occurrence of stroke or systemic embolism. The primary safety outcome was the occurrence of major bleeding, defined as clinically overt bleeding accompanied by one or more of the following: a decrease in the hemoglobin level of 2 g per decilitre or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding.1

  • The study was terminated early due to a clear benefit in favour of ELIQUIS® for the primary endpoint1

In a double-blind study, 5599 randomly assigned patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable received ELIQUIS® (at a dose of 5 mg twice daily*) or ASA (81 to 324 mg per day**), to determine whether ELIQUIS® was superior.1

  • Inclusion Criteria

Eligible patients were 50 years of age or older and had atrial fibrillation documented in the 6 months before enrollment or by 12-lead electrocardiography on the day of screening. Patients also had to have at least one of the following risk factors for stroke: prior stroke or transient ischaemic attack, an age of 75 years or older, arterial hypertension (receiving treatment), diabetes mellitus (receiving treatment), heart failure (New York Heart Association class 2 or higher at the time of enrollment), a left ventricular ejection fraction of 35% or less, or documented peripheral-artery disease. In addition, patients could not be receiving VKA therapy either because it had already been demonstrated to be unsuitable for them or because it was expected to be unsuitable.1

  • Exclusion Criteria

Any of the following risk factors: valvular disease requiring surgery, conditions other than atrial fibrillation for which patients required long-term anticoagulation, a serious bleeding event in past 6 months or high risk of bleeding, current alcohol or drug abuse or psychosocial issues, severe renal insufficiency, ALT or AST > 2x ULN, total bilirubin more than 1.5 x ULN, Life expectancy < 1 year.1

  • Baseline Characteristics

Baseline characteristics are representative of the general non-valvular atrial fibrillation (NVAF) population1

Baseline Characteristics

averroes eliquis (apixaban) trial baseline characteristics image

ISTH=International Society on Thrombosis and Haemostasis
Adapted from reference 1.

ELIQUIS® demonstrated superior efficacy vs. ASA in preventing stroke or systemic embolism In patients for whom vitamin K antagonist therapy was considered unsuitable, ELIQUIS®, as compared with ASA, reduced the risk of stroke or systemic embolism by more than 50%, without a significant increase in the risk of major bleeding.1

  • Superiority study was terminated early due to a clear benefit in favour of ELIQUIS® for the primary endpoint1

ELIQUIS® provided no significantly increased risk of major bleeding vs. ASA1

Major bleeding event was seen in 44 patients receiving ELIQUIS® and in 39 patients receiving ASA (HR 1.13 with ELIQUIS®, 95% CI [0.74-1.75], p = 0.57).1

A significantly lower permanent study drug discontinuation rate at 2 years was seen for ELIQUIS® vs ASA (17.9%/year vs. 20.5%/year p = 0.03).1

ELIQUIS®: the only NOAC that demonstrated superior risk reduction in stroke/systemic embolism with a comparable major bleeding profile to ASA1

averroes eliquis (apixaban) trial risk reduction in stroke / systemic embolism image

Adapted from reference 1.
RRR = Relative Risk Reduction
NOAC = Non-vitamin K oral anti coagulant

In patients with atrial fibrillation for whom vitamin K antagonist therapy was unsuitable, ELIQUIS® reduced the risk of stroke or systemic embolism without significantly increasing the risk of major bleeding or intracranial haemorrhage.1

*94% of ELIQUIS patients received a 5 mg BD dose. A 2.5 mg BD dose was used in a subset of ELIQUIS patients (6%) who met two or more of the following criteria: an age of 80 years or older, a body weight of 60 kg or less, or a serum creatinine level of 1.5 mg per decilitre (133 μmol per litre) or more.1**A dose of 81 mg daily was used in 64% of patients in the ASA group.1
**A dose of 81 mg daily was used in 64% of patients in the ASA group.1

Risk Minimisation Materials

The Eliquis (apixaban) Prescriber Guide and Patient Alert Card are risk minimisation materials developed for all indications as an aid to prescribing, in particular they are aimed at increasing awareness about the potential risk of bleeding during treatment with apixaban and providing guidance on how to manage that risk. Printed copies of these educational materials may be obtained by contacting the Bristol-Myers Squibb Medical Information Department (telephone: 1800 749 749; e-mail: medical.information@bms.com). Alternatively, electronic copies can be accessed via the HPRA website at http://www.hpra.ie/homepage/medicines/medicines-information/find-a-medicine.

References:

  1. Connolly SJ, Eikelboom J, Joyner C et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011;364:806-817.