Therapeutic compliance with rivaroxaban in preventing stroke in patients with non-valvular atrial fibrillation: CUMRIVAFA study

Abstract

Objective: To assess compliance with treatment with rivaroxaban in patients with non-valvular atrial fibrillation.

Methods: Prospective, longitudinal, multicenter study, developed in 160 Spanish primary or specialized care centers. We included 412 patients treated with rivaroxaban, prescribed for stroke prevention. Three visits were conducted: baseline, 6 and 12 months. Compliance was measured by using electronic monitors (MEMSs) that use a digital record in the form of a microchip in the lid of the drug container that automatically controls its opening and registers the time and date of the opening. We calculated the average compliance percentage (CP), global and daily compliance. We considered compliance to be when CP was 80–100%.

Results: Three hundred and seventy patients ended the study (mean age 75.19, SD: 7.5 years). Global compliance was 84.1% (CI = 79.21–88.99%) and 80.3% (CI = 74.98–85.62%) after 6 and 12 months respectively. Daily compliance was 83.5% (CI = 78.53–88.57%) and 80% (CI = 74.65–85.35%) at 6 and 12 months. Significant differences in the CP between 6 and 12 months were observed. Global CP was 90.77% after 6 months and 89.65% at the end of the study. Daily CP was 90.14% and 87.66% at 6 and 12 months. There were significant CP differences between 6 and 12 months. Non-compliance was associated with a higher number of concomitant diseases, number of drugs taken and weight.

Conclusions: The percentage of compliance with rivaroxaban was high. A profile of variables that need to be modified in current medical practice, associated with non-compliance, was detected.

Keywords:

• Non-valvular atrial fibrillation
• Oral anticoagulants
• Preventing stroke
• Rivaroxaban
• Therapeutic compliance

Transparency

Declaration of funding

The study was supported by a research grant from Bayer Laboratories.

Declaration of financial/other relationships

E.M.-C., N.M.-C., V.G.-G., M.D.L.F.-V.W., E.S.-L., S.M.-R., I.G.-G., and E.H.-C. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors would like to thank the researchers of the CUMRIVAFA study for the work done, as well as the rest of the members of the Compliance Study Group of the Spanish Society of Hypertension (SEH-LEHLA).

Previous presentation: This study was presented as an oral communication at the XIX National Meeting of the Spanish Society of Hypertension, Oviedo, March 2015.