106 CHAPTER 7 ABSTRACT Introduction: There is ambiguity whether frail patients with atrial fibrillation managed with vitamin K antagonists (VKA) should be switched to a non–VKA oral anticoagulant (NOAC). Methods: We conducted a pragmatic, multicentre, open-label, randomised controlled superiority trial. Older patients with atrial fibrillation living with frailty (≥75 years of age plus a Groningen Frailty Indicator score ≥3) were randomly assigned to switch from international normalised ratio guided VKA treatment to a NOAC or to continue VKA treatment. Patients with a glomerular filtration rate <30 mL/min/1.73 m2 or with valvular atrial fibrillation were excluded. Follow-up was twelve months. The causespecific hazard ratio was calculated for the occurrence of the primary outcome, that was a major or clinically relevant non-major bleeding complication, whichever came first, accounting for death as a competing risk. Analyses followed the intention-totreat principle. Secondary outcomes included thromboembolic events Results: Between January 2018 and June 2022, a total of 2,621 patients were screened for eligibility and 1,330 patients were randomly assigned (mean age of 83 years, median Groningen Frailty Indicator score of 4). After randomisation, 6 patients in ‘the switch to a NOAC arm’ and 1 patient in ‘the continue with a VKA arm’ were excluded due to the presence of exclusion criteria, leaving 662 patients who switched from a VKA to a NOAC and 661 patients who continued with a VKA in the intention-to-treat population. After 163 primary outcome events (101 in the switch arm and 62 in the continue arm), the trial was stopped for futility according to a prespecified futility analysis. The hazard ratio for our primary outcome was 1.69 (95% CI 1.23–2.32). The hazard ratio for thromboembolic events was 1.26 (95% CI 0.60–2.61). Conclusion: Switching international normalised ratio guided VKA treatment to a NOAC in frail older patients with atrial fibrillation was associated with more bleeding complications compared with continuing VKA treatment, without an associated reduction in thromboembolic complications.
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