Poor Control of Anticoagulant Therapy Leads to Increased Adverse Events for Patients with Atrial Fibrillation (AF)

-- Global GARFIELD Registry data presented at American Heart Association Scientific Sessions provides insight into stroke, bleeding and mortality risk in everyday clinical practice--

LOS ANGELES, Nov. 7, 2012 /PRNewswire/ -- Twelve-month data from the Global Anticoagulant Registry in the FIELD (GARFIELD) show that poor management of stroke prevention therapy is widespread in everyday clinical practice, which may lead to elevated rates of mortality, stroke and bleeding among individuals with newly diagnosed with atrial fibrillation (AF).

Data from the GARFIELD Registry describes AF management and outcomes in everyday clinical practice, highlighting unmet needs and challenges in the use of anticoagulation, which is known to significantly lower stroke risk in AF patients. The data presented today at the American Heart Association (AHA) Scientific Sessions evaluated clinical outcomes, such as stroke, major bleeding and mortality, in relation to patient risk profiles and antithrombotic treatments in a representative worldwide AF population.

Of the 9,971 patients observed, only 5,724 (57 percent) were treated with a vitamin K antagonist (VKA). Of those patients, 57 percent were not treated effectively, with a poorly controlled International Normalized Ratio, or INR, a measure of how long it takes the blood to clot.

In this analysis, only 24.5 percent of patients received well-controlled VKA therapy in clinical practice. In the first year from diagnosis with AF:

-- 2.2 percent of patients died and 1.3 percent experienced a stroke or
systemic embolism (SE).
-- In patients not treated with a VKA, these event rates rose to 2.85
percent and 1.54 percent, respectively.
-- Among patients treated with a VKA, effective versus poor anticoagulant
control results were: 0.86 percent versus 1.72 percent annual mortality
and 0.86 percent versus 1.34 percent annual stroke/SE.

Up to two percent of the population has AF, a common condition in which the two upper chambers of the heart (the atria) quiver rather than beat rhythmically and can lead to life-threatening complications, including stroke.[1] AF-related stroke remains a major and increasing clinical and societal burden, despite the availability of effective preventive treatment.

"These first 12-month data from GARFIELD demonstrate a high mortality rate in patients with newly diagnosed atrial fibrillation," said Professor Ajay Kakkar, Director of the Thrombosis Research Institute, London, Professor of Surgery, University College London and Chair of the GARFIELD Steering Committee. "We know that anticoagulation can improve patient outcomes in AF, but if it is not controlled properly, as appears often to be the case in actual practice, patients may be put at increased risk for poor clinical outcomes. Further insights into real world outcomes will be provided in the second year of follow-up."

Of 10,537 patients enrolled in GARFIELD Cohort 1, follow-up data were available for 9,971 patients. These data, presented in the Special Reports hotline session, showed:

-- Ninety seven percent of patients had a CHA2DS2-VASc score of 1 or
higher, putting them at high risk for stroke and making them eligible
for anticoagulation therapy, according to established clinical
-- One-year event rates for patients receiving VKA therapy (n=5,727) versus
those not on VKA therapy (n=4,244) included:

-- Stroke/SE (1.07 percent versus 1.54 percent, respectively)
-- Major bleed (.75 percent versus .36 percent, respectively)
-- Death (1.74 percent versus 2.85 percent, respectively)
-- Event rates based on VKA time in the therapeutic range (TTR) ≥60
percent (n=2,009) versus

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