Educating patients with atrial fibrillation who are at risk for stroke did not increase their overall use of oral anticoagulation (OAC), the IMPACT-AFib study shows.
The study results were presented as a Hot Line trial Tuesday at the European Society of Cardiology 2020 virtual congress by Sean D. Pokorney, MD, of Duke Clinical Research Institute.
OAC is used to prevent stroke in patients with atrial fibrillation. Warfarin reduces the relative risk for stork by 64% in comparison with placebo. New OAC therapies have been found to reduce the relative risk for stroke by 19% in comparison with to warfarin. However, only about half of the patients who can benefit from new OAC treatment actually receive it.
In the IMPACT-AFib study, patients with atrial fibrillation who were ≥30 years old, had a CHA2DS2-VASc score ≥2, who had no hospital admission for bleeding in the past 6 months and who had not been prescribed OAC in the past year were randomly assigned to either receive patient and provider educational information regarding stroke preventing treatment or to receive standard care. The aim of the study was to increase use of anticoagulation among patients with atrial fibrillation at high risk for stroke.
The primary outcome was the proportion of patients who started anticoagulation over the course of a year. Secondary outcomes were days on OAC, number of patients on OAC at 1 year, stroke or bleeding admissions, and death.
A total of 47,333 patients were found from a number of national databases to be eligible for the study. Of these, 23,546 patients and their providers received a one-time educational mailing. The study population had an average age of 77 years, nearly 50% were women, and the patients were at high risk for both stroke (mean CHA2DS2-VASc score of 4.5) and bleeding (nearly 50% with an ATRIA score of ≥5.
At 12 months, there was no difference in the proportion of patients starting OAC treatment between the two groups, with an OAC initiation rate of 10%. Furthermore, no difference was seen between the group in different times through the year, except that numerically more patients started OAC just after receiving the mailing.
Pokorney concluded that, as a whole, the rate of OAC initiation was only 10% in both the education and control groups. Numerically more patients initiated OAC early after mailing, he added, raising the question of whether more mailings or further contact with the patients may have improved the rate of OAC initiation.
The study was funded by the U.S. Food and Drug Administration (FDA).