P303Higher persistence but lower compliance with direct oral anticoagulants treatment for atrial fibrillation following a personalized therapeutic information: paradoxical results of the MONACO study

Abstract

Background: Despite multiple patient education programs for VKAs, studies have shown a poor level of patient knowledge about stroke and bleeding risks, and a non optimal VKAs compliance have been often described. Direct oral anticoagulants (DOAC) have demonstrated non inferiority compared to VKA's and share a much more convenient administration scheme, without the need of blood tests for dosage adaptation. But this convenience could carry the risk of lower drug compliance, and this could lower the benefits of these new drugs in real life prescription. The DOACs risk management program required by the regulatory agencies include patient information, with a specific OAC information card to be carried by the patient. The goal of the study is to assess the additionnal impact of a personalized therapeutic information on compliance on rivaroxaban, prescribed once a day as VKAs. Methods: the study is a randomized, parallel, single blind, placebo control, usual care non-interventional study with 1y follow-up. Patients recently prescribed rivaroxaban received either usual information centered on the NOAC information card (group C control) or a personalized therapeutic information (group A active) at days 15, 30, and 45 including 3 phone calls, paper booklets offer, and websites suggestion. Knowledge and compliance were evaluated at 6 and 12 months by phone with dedicated questionnaires (8-item Morisky Medication Adherence Scale : MMAS-8). Results: 196 pts were included (97 in A and 99 in C groups). Age was 70y, 60% were male, CHADSVASc was 3,06 +- 1,5, HAS BLED was 1,36 +- 0,8. At 1y, persistence was higher in A group, 98% (90/92) vs 76% (76/92) (p<0,001). Reasons for cessation were in group A side effects (n=2), and in group C side effects (n=6), physician décision (n=13), patient décision (n=3). But compliance (primary outcome, mesured per-protocol by design) was paradoxically slightly lower, at 7,4 +- 0,8 vs 7,6 +- 1,1 (p=0,02). Knowledge results were mostly similar in the 2 groups. Conclusion: A dedicated and personalized therapeutic information could improve drug persistence, perhaps by keeping less compliant patients from DOACs cessation for often futile reasons. These patients should be the target of educationnal programs.