-- One-year outcomes from the GARFIELD-AF Registry show poor VKA control
and high risk scores increased mortality and strokes in newly diagnosed
atrial fibrillation (AF) patients --
TORONTO, June 22, 2015 /CNW/ - Real-life data from nearly 17,200
patients enrolled in the Global Anticoagulant Registry in the Field -
Atrial Fibrillation (GARFIELD-AF) confirm that failing to achieve
adequate management of anticoagulation with vitamin K antagonists (VKA)
and high risk scores are associated with increased risk of mortality
and stroke in patients with non-valvular AF. These findings were
presented in two oral presentations at the 2015 Congress of the
International Society on Thrombosis and Haemostasis (ISTH) today.
"Patients with newly diagnosed atrial fibrillation followed in the
GARFIELD-AF Registry carry an important burden of disease in the first
year after diagnosis," said Professor Ajay Kakkar, Professor of Surgery
at University College London, and Director of the Thrombosis Research
Institute. "The data recently presented from the GARFIELD-AF study
emphasised the benefits of effective anticoagulation for appropriate
patients with newly diagnosed atrial fibrillation."
The presentations at the ISTH congress were as follows:
Risk profiles and 1-year outcomes of patients with newly diagnosed
atrial fibrillation: Results from GARFIELD-AF
The incidence of stroke/systemic embolism, death and major bleeding one
year after a new diagnosis of non-valvular AF were analysed by
patients' baseline characteristics and antithrombotic therapy provided
at diagnosis. The results showed that:
Mortality is the highest burden in the first year after a diagnosis of
Higher risk scores (CHA2DS2-VASc and HAS-BLED) are associated with increased risk of death,
stroke/SE and major bleeding events
Smoking, age ≥75 years, lack of anticoagulant treatment and kidney
disease are also associated with increased risks of death, stroke/SE
and major bleeding events
Cardiac failure at baseline is associated with increased risk of death,
but hypertension at baseline reduces the risk of death
Quality of vitamin K antagonist control and 1-year outcomes: A global
perspective from the GARFIELD-AF registry
The study analysed time in therapeutic range (TTR) of international
normalised ratio (using the target range of 2.0-3.0) in patients with
newly diagnosed non-valvular AF in relation to demographics, care
settings and 1-year outcomes. TTR is an indicator of the quality of VKA
control and may also be used as an indicator of outcome. European
Society of Cardiology guidelines recommend a TTR of ≥70%. The results showed that:
Poor VKA control was associated with increased risk of mortality and
stroke/systemic embolism (SE)
Increasing TTR from 60% to 70% may reduce the risk of stroke/SE
Fewer patients diagnosed at a hospital have good control versus patients
diagnosed at an office or anticoagulation clinic/thrombosis centre
Heavy alcohol consumption is more frequent in patients with poor
Overall, good VKA control is of major clinical importance
These new GARFIELD-AF analyses were based on data from Cohorts 1 and 2,
which included 17,168 patients recruited between 2010 and 2013.
GARFIELD-AF is an independent academic research initiative, led by an
international steering committee under the auspices of the Thrombosis
Research Institute (TRI), London, UK. To date, GARFIELD-AF has
recruited over 40,000 patients with newly diagnosed AF in 35 countries,
making it one of the largest observational studies in this therapeutic
area. With recruitment for Cohort 5 about to start, the Registry will
eventually include up to 57,000 patients.
About the GARFIELD-AF Registry
GARFIELD-AF is an observational, multicentre, international prospective
study of patients with newly diagnosed AF. It will prospectively follow
up to 57,000 patients from at least 1,000 centres in 35 countries in
the Americas, Eastern and Western Europe, Asia, Africa and Australia.
The start of the Registry coincided with the beginning of the
non-vitamin K anticoagulants (NOACs) era of treatment for AF.
Contemporary understanding of AF is based on data gathered in controlled
clinical trials. Whilst essential for evaluating the efficacy and
safety of new treatments, these trials are not representative of
everyday clinical practice and, hence, uncertainty persists about the
real-life burden and management of this disease. GARFIELD-AF seeks to
provide insights into the impact of anticoagulant therapy on
thromboembolic and bleeding complications seen in this patient
population. It will provide a better understanding of the potential
opportunities for improving care and clinical outcomes amongst a
representative and diverse group of patients and across distinctive
populations. This should help physicians and healthcare systems to
appropriately adopt innovation to ensure the best outcomes for patients
The registry started in December 2009. Four key design features of the
GARFIELD-AF protocol ensure a comprehensive and representative
description of AF, these are:
Five sequential cohorts of prospective, newly-diagnosed patients,
facilitating comparisons of discrete time periods and describing the
evolution of treatments and outcomes.
Investigator sites that are selected randomly within carefully assigned
national AF care setting distributions, ensuring that the enrolled
patient population is representative.
Enrolment of consecutive eligible patients regardless of therapy to
eliminate potential selection bias.
Follow-up data captured for a minimum of 2 and up to 8 years after
diagnosis, to create a comprehensive database of treatment decisions
and outcomes in everyday clinical practice.
Included patients must have been diagnosed with non-valvular AF within
the previous 6 weeks and have at least one additional risk factor for
stroke; as such they are potential candidates for anticoagulant therapy
to prevent blood clots leading to stroke. It is left to the
investigator to identify a patient's stroke risk factor(s), which need
not be restricted to those included in established risk scores.
Patients are included whether or not they receive anticoagulant
therapy, so current and future treatment strategies and failures can be
properly understood in relation to patients' individual risk profiles.
The GARFIELD-AF Registry is funded by an unrestricted research grant
from Bayer Pharma AG.
The burden of AF
Up to 2% of the global population has AF. Around 6 million people in Europe, 3-5 million people in the United States, and up to 8 million people in China have AF., It is estimated that its prevalence will at least double by 2050 as the
global population ages. AF confers a five-fold increase in the risk of
stroke, and one in five of all strokes is attributed to this
arrhythmia. Ischaemic strokes associated with AF are often fatal, and
those patients who survive are left more frequently and more severely
disabled and more likely to suffer a recurrence than patients with
other causes of stroke. In consequence, the risk of death from
AF-related stroke is doubled and the cost of care is increased by 50%.
AF occurs when parts of the atria emit uncoordinated electrical signals.
This causes the chambers to pump too quickly and irregularly, not
allowing blood to be pumped out completely. As a result, blood may pool, clot and lead to thrombosis, which is the
number one cardiovascular killer in the world. If a blood clot leaves the left atrium, it could potentially lodge in
an artery in other parts of the body, including the brain. A blood clot
in an artery in the brain leads to a stroke. Ninety-two per cent of
fatal strokes are caused by thrombosis. People with AF are also at high risk for heart failure, chronic fatigue
and other heart rhythm problems. Stroke is a major cause of death and long-term disability worldwide -
each year 6.7 million people die and 5 million are left permanently disabled.
About the TRI
The TRI is a charitable foundation and multi-disciplinary research
institute dedicated to the study of thrombosis and related disorders.
TRI's mission is to provide excellence in thrombosis research and
education, to develop new strategies to prevent and treat thrombosis
and thereby improve quality of care, advance clinical outcomes and
reduce healthcare costs. The TRI is a member of University College
London Partners Academic Health Science System.
For more information, visit http://www.tri-london.ac.uk/garfield.
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SOURCE Thrombosis Research Institute (TRI)