​GARFIELD AF: Providing innovative solutions through improved registries
Melanie Blackwood
Sep 29, 2017

At IQVIA, we talk a lot about the value that registries bring to the clinical research process. These online platforms allow patients and physicians to record real-world data about their diagnosis, treatment and condition to support a specific research agenda. These observational studies enhance the breadth and depth of our understanding of the disease condition and ultimately can help us develop treatments and strategies for improving patient outcomes worldwide.

In recognition of World Heart Day on September 29, I’d like to talk about one registry in particular that demonstrates how these platforms can complement clinical research to drive innovative solutions in patient care. The Global Anticoagulant Registry Atrial Fibrillation (GARFIELD AF) is a pioneering real-world prospective registry launched by the Thrombosis Research Institute (TRI) in August 2009 to enhance our understanding of stroke prevention in atrial fibrillation. The goal of The GARFIELD Registry is to use real-world data from more than 1000 centers, representing all possible care settings around the world, to describe acute and long-term management and outcomes in patient populations representative of everyday clinical practice within each participating country and rolled up for a global perspective.

There is tremendous interest in understanding how patients with atrial fibrillation are managed, especially since the introduction of novel oral anti-coagulants. In the past 15 years there have been several registries created to address this issue, though GARFIELD AF stands out as the largest and most comprehensive in terms of the numbers of patients, countries and diversity of site representation, with more than 47,000 patients already recruited from 35 countries across the Americans, Europe, Middle East and Asia Pacific. GARFIELD-AF is also unusual in its funding and approach to giving back to the medical communities that support it. All decisions are made by the Registry and its Steering Committees, and the outcomes will be available to patients, clinicians, healthcare workers, health systems and other stakeholders interested in the results.

Not only will the registry provide a broad perspective on the condition and treatments for AF worldwide, it allows researchers to deconstruct the data to gain insights into the unique experiences of patients based on their country, age, gender, economic bracket, co-morbidities and other factors.

This type of real-world information is becoming increasingly important as health systems make decisions about which treatments to reimburse, and as clinicians and patients become more interested in localized and personalized data. By following so many patients over several years in this registry, we will be able to see the long-term impact of treatment and how outcomes compare across countries and patient populations. These data will help clinicians better understand how to improve care and outcomes for these patients. It will also inform future clinical research into AF, including where there are unmet medical needs, site selection for trials, inclusion/exclusion criteria, patient engagement opportunities, and where treatment-naive patient populations are most likely to be found.

Having an impact

The data are already providing insights into rates of stroke and bleeding complications, as well as other important issues, such as treatment practices, physicians' compliance with guidelines and patients' adherence to therapy. In September, 2015, registry leaders presented data from the study at the European Society of Cardiology conference, outlining global and local insights and opportunities they provide to improve care for patients around the world.

Some of the highlights include:

  • Two year outcomes data from 17,000 newly diagnosed patients show that all-cause death was the most frequent major event in this patient population, far exceeding the rate of stroke or major bleeding.
  • Additional one-year outcomes from more than 28,000 AF patients demonstrate a likely impact of comorbidities on increasing mortality, stroke and major bleeding, indicating the importance of comorbidities in predicting patient outcomes.
  • Insights from nearly 40,000 patients across the four sequential cohorts show a clear shift in how AF is being managed across the globe. Overall, patients initiated on anticoagulant treatment for stroke prevention increased from 57.4% to 71.1%with the use of non-vitamin K antagonist oral anticoagulants (NOACs) increasing, indicating an evolution in the adoption of innovative therapies for stroke prevention. However, the rate of increase varied considerably across regions. In Europe for example, increased use of NOACS ranged from just 2.6% in Finland to 58.0% in Belgium, suggesting the need for more consistent guidance for physicians on the best care path for AF patients.
  • The data also show that anticoagulant therapy, particularly vitamin K antagonists which are known to prevent stroke, are underutilized in AF patients who are at high risk for stroke, while at the same time being over-used in low-risk patients.

These early results already are enhancing our understanding of the burden of AF across countries and providing insights into how we might balance the benefits and risks of anticoagulant therapy for patients.

The GARFIELD Registry is not only changing the way we approach heart disease research, it is proving the value of long-term global registries to informing the care process. An effective registry that engages global patient populations and shares research across the stakeholder community has the power to change the global treatment paradigm. We look forward to seeing what new insights this registry delivers in the coming years.

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