This article is more than 5 years old. Information may no longer be current.
AEGEAN: Adherence program does not provide additional value to apixaban users
Click Here to Manage Email Alerts
LONDON — An educational program on treatment adherence for users of apixaban did not provide any additional value at 6 months compared with the standard of care, according to findings presented at the European Society of Cardiology Congress.
However, 6-month adherence rates and persistence rates were high in both groups, Cardiology Today’s Intervention Editorial Board member Gilles Montalescot, MD, PhD, said during a press conference.
Gilles Montalescot
Montalescot, professor of cardiology and head of the cardiology department at Pitié-Salpêtrière Hospital, Paris, and colleagues investigated whether a proactive educational program on adherence to treatment with the novel oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) would impact patients with nonvalvular atrial fibrillation taking the drug for stroke prevention.
Montalescot said that while adherence data on novel oral anticoagulants is limited, adherence could be suboptimal because, unlike with vitamin K antagonists such as warfarin, regular visits to anticoagulation clinics are not required.
For the AEGEAN study, the researchers randomly assigned 583 patients to receive standard care and 579 to receive an additional educational program about apixaban, including a patient education booklet; reminder tools such as key rings, text messages and smartphone apps; and access to a virtual clinic staffed by people from existing anticoagulation clinics.
The researchers defined adherence as a 24-hour window in which a patient took apixaban twice daily, or in which a patient took one tablet but had not missed either dose on previous days. They defined nonadherence as a 24-hour window in which two consecutive tablets were missed; a second consecutive day of one tablet being missed; or when one tablet was missed on alternate days, with the second day identified as the day of nonadherence.
They defined persistence as the absence of permanent discontinuation, or taking no doses for 30 days in a row or longer.
Rates of adherence were measured using an electronic monitoring device (Helping Hand, B&O Medicom).
At 6 months, adherence rates were 88.51% in the standard care group and 88.34% in the educational-program group (P = .89), Montalescot said. Persistence rates at 6 months were 90.5% in the standard care group and 91.1% in the educational-program group (P = .76).
While the study was not powered to detect differences in clinical outcomes, seven patients in the educational-program group had strokes, transient ischemic attacks or systemic emboli (1.2%) compared with one (0.2%) in the standard care group. Rates of other clinical outcomes were similar, he said.
“The study shows a high adherence rate, 88%, in the first 6 months of apixaban given twice daily for the treatment of [stroke prevention in AF],” Montalescot said. “There was also a high persistence rate, 91%, over the same period with apixaban. There was no additional value of a proactive educational program on adherence to this treatment.”
Results from the second phase of the study, in which patients in the educational-program group were randomly assigned to standard of care or continued use of the program for another 6 months, will be presented in the future, Montalescot said. – by Erik Swain
Reference:
Montalescot G, et al. Hot Line II: Atrial Fibrillation and Pacing. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 2; London.
Disclosures: The study was sponsored by Bristol-Myers Squibb. Montalescot reports receiving research grants to his institution or consulting/lecture fees from Acuitude, ADIR, Amgen, AstraZeneca, Bayer, Berlin Chimie, 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, Merck, Pfizer, Recor, Sanofi Aventis, Stentys, The Medicines Company, TIMI Study Group, Universitat Basel, WebMD, Williams & Connolly, and Zoll Medical.
Perspective
Back to Top
Patrick T. O’Gara, MD, MACC
Although the study results are neutral, the very high levels of adherence reported for both the intervention and control groups are truly spectacular. It’s too early to tell, though, whether the educational program might reap benefits over longer-term follow-up. Perhaps the control group was particularly motivated and wanted to perform well. This may be a challenge for all studies of this type. How educational programs may work among a non-selected population remains to be seen. We should not give up on the notion that effective education is a major piece of effective and high quality care.
Click Here to Manage Email Alerts