Real-Life Evidence of Stroke Prevention in Patients with Atrial Fibrillation

Background1

  • While Xarelto® has been shown to be effective in reducing the risk of stroke in NVAF NVAF
    Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
    patients in a randomised controlled trial,2 scarce data comparing real life outcomes between Xarelto and vitamin K antagonist (VKA VKA
    Vitamin K antagonist (= VKA). An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment are required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.
    ) users with NVAF are available3

Objective

  • Compare the effectiveness of newly-initiated Xarelto or VKA therapy amongst NVAF patients in Germany1

Study Design

  • The RELIEF study was a retrospective study performed in German outpatients using data from an electronic medical record database1

Primary End Point

  • Time-to-composite of ischaemic stroke, TIA TIA
    Transient ischaemic attack (= TIA). Also known as a ‘mini stroke’. This is caused by a temporary disruption in the blood supply to part of the brain.
    , intracerebral haemorrhage, other non-traumatic ICH ICH
    Intracranial haemorrhage (= ICH). This is bleeding within the skull.
    including subdural haemorrhage and MI MI
    Myocardial infarction (= MI). This is commonly known as a heart attack. This is usually caused by a blood clot that stops the blood flowing to part of the heart muscle. As a result, the heart muscle becomes damaged.
    within one year of treatment initiation1

Limitations

  • A small number of primary events were observed1
  • Data may contain coding inaccuracies/missing data that can result in biases; the potential of residual confounding cannot be excluded1
  • The current analysis used only cohorts of patients with a follow-up of ≥360-days; bias in either cohort due to the exclusion of patients with lesser follow-up cannot be ruled out1

Key Findings

  • This study suggests Xarelto is associated with favourable effectiveness in NVAF patients without previous events compared to a VKA when utilised in a real life setting1
  • Further analysis containing INR INR
    International normalised ratio (= INR). A system for assessing the clotting tendency of blood in patients receiving anticoagulant therapy. For patients with atrial fibrillation, the recommended target INR range is between 2 and 3. If the INR is higher than 3, patients are at risk of serious bleeding. If the INR is less than 2, patients are at risk of a blood clotting event.
    and effectiveness data is warranted1

NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
, non-valvular atrial fibrillation; VKA VKA
Vitamin K antagonist (= VKA). An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment are required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.
, vitamin K antagonist; TIA TIA
Transient ischaemic attack (= TIA). Also known as a ‘mini stroke’. This is caused by a temporary disruption in the blood supply to part of the brain.
, transient ischaemic attack; ICH ICH
Intracranial haemorrhage (= ICH). This is bleeding within the skull.
, intracranial haemorrhage; MI MI
Myocardial infarction (= MI). This is commonly known as a heart attack. This is usually caused by a blood clot that stops the blood flowing to part of the heart muscle. As a result, the heart muscle becomes damaged.
, myocardial infarction.