In this US Food and Drug Administration-funded prospective trial, patient selection and followup were via the databases of five insurance companies. Patients aged ≥30 years with AF and a guideline-based indication for OAC (CHA₂DS₂-VASc score of ≥2) were included. Participants were excluded if they had been prescribed an anticoagulant in the prior 12 months or been admitted to hospital for bleeding in the prior 6 months. Patients were randomised to an educational intervention group, where the patient and their healthcare provider received one mailing at the start of the trial, or to a control group who received usual care.
In 47,333 patients analysed from four insurance companies, the primary endpoint of OAC initiation over the course of the 12-month trial occurred in 9.89% of patients in the intervention group and 9.80% of patients in the control group (adjusted odds ratio 1.01; 95% confidence interval 0.95–1.07). The researchers found that numerically more patients initiated OAC early after the mailing was sent out, but this effect attenuated over time. There were no significant differences between the groups when secondary clinical outcomes were investigated including ischaemic stroke and major bleeding.
Dr. Pokorney concluded that in the novel and pragmatic IMPACT-AFib trial, a single mailing was not an effective way to increase the rates of anticoagulation use in this patient population. Numerically higher OAC initiation early after the mailing was sent out raises the question of whether multiple mailings or further contact may have been beneficial.