A guideline-directed conversation guide designed to promote shared decision-making (SDM) among patients with nonvalvular atrial fibrillation (AF) starting or reviewing anticoagulation treatment was found to result in similar adherence and clinical safety outcomes compared with usual care alone. The study findings were published in the Journal of the American Heart Association.
This analysis was a prespecified 10-month follow-up of a multicenter encounter-randomized control trial (ClinicalTrials.gov Identifier: NCT02905032). Patients with nonvalvular AF who were considering starting or reviewing current anticoagulation therapy were randomly assigned to receive SDM (n=463) or usual care (n=459). Primary and secondary adherence rates and clinical outcomes were assessed. The SDM in this study was Anticoagulation Choice, a conversation aid for encounters with patients with AF who are candidates for anticoagulant use for the prevention of stroke.
The intervention and control cohorts had a mean age of 71 (standard deviation [SD], 11) and 71 (SD, 10) years; 37% and 42% were women; 85% and 84% were White; 21% and 22% were considering starting anticoagulant use; and 22% and 25% were in poor health at baseline, respectively.
Most patients and clinicians (55%) chose direct oral anticoagulants with most (approximately 60%) selecting apixaban. During follow-up, one-fifth of patients changed to another medication.
Among both treatment arms, approximately 80% filled their first prescription after consulting with their clinician, indicating that SDM was not more effective at encouraging patients to adhere to medication than usual care.
Stratifying by risk status or prescribed medication did not reveal differential patterns of adherence. However, a modest interaction was observed among patients with preenrollment adherence in the SDM treatment arm (odds ratio [OR], 1.75; 95% CI, 1.05-2.93; P=.03).
Clinical safety was 13% and 14% in the intervention and control arms, respectively. Major bleeding was the most frequent event, occurring among 10% to 11% of patients. Within the intervention and control cohorts, rates of stroke (2% vs 1%) and death (3% vs 4%) did not differ significantly, respectively.
This study may have been limited by its sample size, and a larger trial is likely needed to differentiate outcomes between patients starting new treatment or continuing current treatment.
“[A] within-encounter SDM tool for use in conversations on anticoagulation for stroke prevention in patients with [AF] had no significant effect on treatment adherence or clinical safety outcomes,” the investigators noted.
Noseworthy PA, Branda ME, Kunneman M, et al. Effect of shared decision-making for stroke prevention on treatment adherence and safety outcomes in patients with atrial fibrillation: A randomized clinical trial. J Am Heart Assoc. Published online January 13, 2022. doi:10.1161/JAHA.121.023048