GARFIELD-AF Registry: All-cause death is most frequent major event in newly diagnosed AF patients

Thrombosis Research InstituteSep 1 2015

- The unique breadth and maturity of GARFIELD-AF Registry data presented atESC Congress 2015 provides real-world insights on the evolution ofmanaging AF in everyday clinical practice across the globe -

The first-ever two-year outcomes from the Global Anticoagulant Registry in the Field - Atrial Fibrillation (GARFIELD-AF) showcased at ESC Congress 2015 expose that all-cause death was the most frequent major event in more than 17,000 newly diagnosed AF patients, far exceeding the rate of stroke or major bleeding. These two-year prospective outcomes from cohorts 1 and 2 show a mortality rate of 3.83% per person year compared to stroke rates of 1.25% per person year and major bleeding rates of 0.70% per person year.

Additional one-year outcomes from more than 28,000 AF patients in cohorts 1-3, demonstrate a likely impact of comorbidities on increasing mortality, stroke and major bleeding. Patients with moderate-to-severe chronic kidney disease and those with a history of myocardial infarction had a markedly higher mortality rate than the overall population (9.4% and 6.9% respectively, compared to 4.0%).^[1] "These data from the GARFIELD-AF registry indicate the importance of comorbidities in predicting patient outcomes and can offer physicians guidance in managing AF," said Professor Sam Goldhaber of Harvard Medical School and the Brigham and Women's Hospital. "The results suggest physicians should consider increasing the prescription of anticoagulants in AF patients with these comorbidities."

Insights from nearly 40,000 patients with AF across the four sequential GARFIELD-AF cohorts from 2010 to 2015 show a 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%. Use of vitamin K antagonists (VKAs) and antiplatelets (combined or alone) fell from 83.4% to 50.6%, whilst use of non-vitamin K antagonist oral anticoagulants (NOACs) with or without an antiplatelet increased from 4.1% to 37.0%.^[1] "This evolution in treatment patterns is consistent with the adoption of innovative therapies for stroke prevention," said Professor Ajay Kakkar, Professor of Surgery at University College London and Director of the Thrombosis Research Institute. "The remaining challenge, however, is to ensure that the correct patient receives the appropriate therapy."

Professor John Camm of St George's University, London expanded on the treatment patterns revealed in GARFIELD-AF: "While we are seeing an overall increase in the use of appropriate anticoagulation therapy, GARFIELD-AF reveals a substantial variation in NOAC uptake between countries. Analysis in over 20,000 newly diagnosed AF patients across Europe from cohorts 1-3 showed these variations ranged from 2.6% to 58.0%.^[2] The ongoing insights being gathered across countries and different care settings will help clinicians better understand how to improve care and outcomes for AF patients."

GARFIELD-AF is the largest ongoing prospective registry of patients with newly diagnosed AF and at least one additional stroke risk factor. The ongoing real-world insights continuing to be gathered from the GARFIELD-AF Registry are being converted into real-world evidence that help inform and identify areas where the medical community can continue to improve patient outcomes.

Additionally GARFIELD-AF data in specific regions and patient populations were presented at ESC Congress 2015:

Vitamin K antagonist control in Eastern and Southeastern Asia^[3]

GARFIELD-AF insights show fewer INR readings, longer intervals between readings and lower INR values in Eastern and Southeastern Asia (n=3,627) compared to countries in other regions of the world (n=13,546). For patients receiving VKAs for newly diagnosed AF in Eastern and Southeastern Asia, results showed:

• Lower INR levels with the majority 2.0, a trend that was seen across all age groups
• Use of anticoagulation in patients with a CHA₂DS₂-VASc score of ≥2 was lower

Stroke, major bleeding and mortality in newly diagnosed atrial fibrillation with moderate-to-severe chronic kidney disease: results from GARFIELD-AF^[4]

One-year outcomes in 17,159 patients with AF reveal differences between patients with moderate-to-severe chronic kidney disease (n=1,760) and those with no or mild chronic kidney disease (n=15,399):

• Moderate-to-severe chronic kidney disease is associated with a two-fold higher rate of mortality and major bleeding, and a 1.4-fold higher rate of stroke
• Use of anticoagulants was more frequent in patients with moderate-to-severe chronic kidney disease
• Further interrogation of mortality and bleeding event rates in the ongoing GARFIELD-AF registry may provide greater insight into balancing the benefits and risks of anticoagulant therapy for patients with AF and chronic kidney disease