Switching vitamin K antagonist (VKA) treatment to a non-vitamin K antagonist oral anticoagulant (NOAC) in frail elderly patients with atrial fibrillation is associated with more bleeding complications compared to continuing VKA treatment. That's the finding of late breaking research presented in a Hot Line session August 27 at ESC Congress 2023.
Participants were randomized in a 1:1 ratio to switch from a VKA to a NOAC or to continue a VKA. The choice of NOAC was left to the discretion of the treating physician. The follow-up duration was 12 months. The cause-specific hazard ratio was calculated for occurrence of the primary outcome which was major or clinically relevant non-major bleeding, whichever came first, accounting for death as a competing risk.
Between January 2018 and April 2022, a total of 1,330 patients were randomized. The mean age was 83 years and 38.8% were women. After 163 primary outcome events , the trial was stopped for futility on advice from the Data Safety and Monitoring Board following a prespecified futility analysis. The HR for the primary outcome of major or clinically relevant non-major bleeding was 1.69 for switching to a NOAC relative to continuing a VKA. The HR for thromboembolic events was 1.26 .
Regarding secondary outcomes, 16 thromboembolic events occurred in the NOAC arm versus 13 in the VKA arm, yielding incidence rates of 2.6 and 2.1 per 100 patient-years, respectively. Study author Dr. Linda Joosten of the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands said,"Switching VKA treatment to a NOAC in frail elderly
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