122 CHAPTER 7 non-randomised, our trial cannot answer whether one NOAC should be preferred over the other in this frail population. Fourth, our trial was not powered to show differences in clinical outcomes in isolation such as haemorrhagic stroke. Due to the small number of events, we cannot draw any conclusions on possible differences between treatment arms. Last, rather than comparing two types of anticoagulant molecules, it is important to acknowledge that our open-label pragmatic trial allows us to draw conclusions from the comparison of two healthcare anticoagulation strategies in older patients living with frailty, namely switching from INR guided VKA therapy to a NOAC or to continue with INR guided VKA therapy. This was done deliberately, because it answers the clinically relevant question on whether a particular AF patient living with frailty should switch from a VKA to a NOAC or not. For this pragmatic clinical question, we decided an open-label design was most appropriate, because this would mimic future clinical care as much as possible. Nevertheless, by design, study procedures were not blinded and, moreover, some bleeding events in the NOAC arm occurred while the patient was (still) taking a VKA, and vice versa. However, the proportion of the bleeding events occurring not on the anticoagulant strategy they were randomly allocated to, was small in both treatment arms: 7 of 101 bleeding events (6.9%) in the NOAC arm and 5 of 62 bleeding events (8.1%) in the VKA arm (see Supplementary file S3). In conclusion, our FRAIL-AF pragmatic trial showed that switching from INR guided VKA treatment to a NOAC compared to continuing with INR guided VKA treatment is associated with more bleeding complications in frail older patients with non-valvular AF. Albeit our trial was not powered to demonstrate differences in thromboembolic events, major bleeding in isolation, haemorrhagic stroke, or the composite of haemorrhagic and ischaemic stroke, there was no clear signal that switching results in reduction of these outcomes in our trial population. Hence, we believe our trial indicates that careful consideration should be applied when choosing between continuing VKA treatment or switching from a VKA to a NOAC in older patients living with frailty.
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