Abstract

Abstract Background Many older patients with atrial fibrillation (AF) are frail, putting them at high risk of adverse outcomes including mortality, hospitalization, functional decline, and dependency on others. In this special population, management strategies – such as anticoagulation for stroke prevention – need special consideration. To what extent the type of anticoagulation influences the quality of life (QoL) in frail patients with AF is unclear. Purpose To assess QoL in frail older patients with AF switching from a vitamin K antagonist (VKA) to a non-VKA oral anticoagulant (NOAC), as compared to patients continuing a VKA. Methods We used data from the FRAIL-AF trial that randomized frail older AF patients between continuing VKA treatment or switching to any NOAC. At baseline, after six months and twelve months of follow-up, QoL was assessed using the EQ-5D-5L questionnaire. For every timepoint, the mean EQ-5D-5L score was calculated with corresponding 95% confidence intervals (CI), missing data were imputed using ten-fold multiple imputation. Absolute differences in EQ-5D-5L score were calculated between patients switching to a NOAC and patients continuing with a VKA, with corresponding 95% CI. The distribution of the scores on each domain of the EQ-5D-5L was compared using a chi-square test. Results In total 661 patients continued VKA treatment, and 663 switched to a NOAC. The median age was 82.2 years (interquartile range (IQR) 78.7 – 86.5), 61.3% were male. Major bleeding or clinically relevant non-major bleeding occurred in 101 patients (17.8 per 100 person-years) switching to NOAC therapy, and 62 patients (10.5 events per 100 person-years) continuing with a VKA (hazard ratio 1.69, 95% confidence interval 1.23 – 2.32). Mortality occurred in 44 and 46 patients, respectively. In 25 patients data was missing. Table 1 shows the mean EQ-5D-5L scores at baseline, at 6 months follow-up and at 12 months follow-up. Scores were similar between patients switching to NOAC treatment or continuing with a VKA and did not change significantly during 12 months follow-up. Table 2 shows the distribution of the scores on all domains of the EQ-5D-5L, with no significant differences between groups. Conclusion Switching from a VKA to a NOAC in frail older patients with AF was associated with an increased risk of bleeding, yet without any effect on overall and different domains of QoL.

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