STUDY NAME: The AEGEAN Trial
SESSION NAME: Hot Line II – Atrial fibrillation/Pacing
Adherence to the oral anticoagulant apixaban among patients with atrial fibrillation (AF) was no better for those who received an educational program compared to those who did not, results of the international, randomised AEGEAN trial show.
The results, presented today at ESC Congress 2015, were nevertheless “quite encouraging,” according to lead investigator Gilles Montalescot, MD, PhD, from the Institut de Cardiologie, Centre Hospitalier Universitaire Pitié-Salpêtriėre, in Paris, France.
“We used the best possible tools for the educational program, including the usual staff and procedures of the anticoagulation clinics, and all of this was useless. However, the trial showed very good adherence to apixaban, leaving little room for improvement with an educational program, suggesting one more advantage of prescribing non-Vitamin K antagonists (VKA) over VKAs in that there is apparently no need for additional education and information,” he said.
VKAs are highly effective for stroke prevention in AF, reducing the risk by about two thirds, but these oral anticoagulants have several drawbacks including a narrow therapeutic range, extensive drug and food interactions, frequent bleeding complications and the need for frequent International Normalized Ratio (INR) monitoring and dose adjustments, explained Professor Montalescot.
Apixaban, like other non-VKAs, has less food and drug interactions compared with VKAs and does not require routine monitoring, he added. But in the absence of routine monitoring there is a risk of poor adherence which might be addressed by patient education.
The AEGEAN trial included AF patients treated with apixaban who received either an educational program (n=579) or usual information about the disease and treatment (n=583) to see if there were differences in two outcomes: treatment adherence (defined as continuous twice daily dosing, with an occasional missed dose allowed) and treatment persistence (defined as absence of discontinuation for 30 consecutive days) over a six month observational period.
The educational program included a patient information booklet explaining AF and anticoagulant treatment for stroke prevention, reminder tools ( e.g., key ring, mobile phone alerts), and access to a virtual clinic utilising staff from existing VKA monitoring clinics. Adherence was measured using an electronic device that holds a blister pack of medication and records each time the pack is removed.
The study found there was no additional value of the educational program on either outcome.
At 24 weeks, the adherence rate was 88.5% in the control group and 88.3% in the education group (P=0.89), and persistence rates were 90.5% and 91.1% respectively (P=0.76).
“Future studies may want to test more aggressive and more costly educational programs, but in the meantime the adherence and persistence rates we measured are quite reassuring with the common practice and usual mode of prescription of this medication,” concluded Professor Montalescot.
Notes to editor
SOURCES OF FUNDING: The study was sponsored by Bristol-Myers Squibb.
DISCLOSURES: Dr. Montalescot has received research grants to the institution or consulting/lecture fees from Acuitude, ADIR, Amgen, AstraZeneca, Bayer, Berlin Chimie AG, Boehringer Ingelheim, Bristol-Myers Squibb, Brigham Women’s Hospital, Cardiovascular Research Foundation, Celladon, CME resources, Conway, Daiichi-Sankyo, Eli-Lilly, Europa, Evidera, Fédération Française de Cardiologie, Gilead, GLG, Hopitaux Universitaires Genève, ICAN, Janssen-Cilag, Lead-Up, McKinsey & Company, Medcon International, Menarini, Medtronic, MSD, Pfizer, Recor, Sanofi-Aventis, Stentys, The Medicines Company, TIMI Study Group, Universitat Basel, WebMD, Williams & Connolly, and Zoll Medical.
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This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2015. Edited by the ESC from material supplied by the investigators themselves, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the presenter.