Switching frail patients with atrial fibrillation from a vitamin K antagonist to a novel oral anticoagulant significantly increased bleeding risk.
According to the findings of the FRAIL-AF trial, switching frail patients with atrial fibrillation (AF) from a vitamin K antagonist (VKA) to a novel oral anticoagulant (NOAC) should not be considered without a clear indication. In contrast to the hypothesis of the research team, switching to a NOAC resulted in a significantly higher risk for bleeding among these patients.
The FRAIL-AF trial investigated whether switching from a VKA to a NOAC reduced bleeding risk in frail older patients with AF, compared with continuing treatment on a VKA. Thus, the 1,330 enrolled patients were randomly assigned 1:1 to either of these options. Linda Joosten, MD, pointed out that the population of the current trial was different from the standard populations tested in NOAC trials, with a mean age of 83 years, a median Groningen Frailty Indicator score of 4, and a median CHA2DS2-VASc score of 4. The primary endpoint of FRAIL-AF was major or clinically relevant nonmajor bleeding.
After 1 year of follow-up, the primary outcome data showed that participants who switched to a NOAC had an increased risk for bleeding compared with those who continued on a VKA (15.3% vs 9.4%; HR, 1.69; 95% CI, 1.23–2.32; P=0.0011). This effect appeared to be driven by an increase in clinically relevant nonmajor bleedings in the NOAC arm (12.7% vs 7.4%; HR, 1.77; 95% CI, 1.24–2.52). Dr. Joosten said that there was no difference in the occurrence of thromboembolic events between VKA-receivers and NOAC-receivers (2.0% vs 2.4%; HR, 1.26; 95% CI, 0.60–2.61). All-cause mortality rates were also similar between both study groups (7.0% vs 6.7%).
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