112 CHAPTER 7 apixaban, and 109 (16.5%) to edoxaban. In the remaining 3 patients (0.5%), information on the prescribed NOAC was missing. In patients randomly assigned to switch from a VKA to a NOAC, dosing followed the market-authorised dosing in most patients, except for 44 patients (6.6%) in whom off-label dose reduction occurred. The mean duration of follow-up was 344 days, and 90 patients died during follow-up (44 (6.6%) in the intervention arm and 46 (7.0%) in the control arm). Of the patients who died, a total number of 31 deaths were cardiovascular-related: 12 cardiovascular deaths (1.8%) in the intervention arm (8 terminal heart failure, 4 fatal myocardial infarction) and 19 cardiovascular deaths (2.9%) in the control arm (14 terminal heart failure, 5 fatal myocardial infarction). A total of 10 deaths were fatal bleedings: 5 (0.8%) in both the intervention and control arm. In total, 8 patients were lost to follow-up: 3 patients in the control arm and 5 patients in the intervention arm. In the remaining 1,269 patients who did not withdraw consent (99.4%) the occurrence of the primary outcomes was ascertained. FIGURE 1: FLOWCHART WITH THE RESULTS OF INCLUSION. eGFR: estimated glomerular filtration rate; ITT: intention to treat; NOAC: non-vitamin K antagonist oral anticoagulant; VKA: vitamin K antagonist.
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