181 GENERAL DISCUSSION Another unanswered question following the results of the FRAIL-AF trial is whether frail older AF patients who are currently prescribed a NOAC or non-frail AF patients who are prescribed a NOAC and become frail later in life should switch to a VKA or not. After all, it is plausible that the switching of medication itself in these frail older patients increases the risk of adverse events (i.e. bleeding in the case of oral anticoagulation), particularly if they were more or less stable under the previous medication (regardless of which way the medication is switched). Perhaps the statement ‘never change a winning team’ applies in the frail older population in general, because the balance in frail older patients (in this case between coagulation and bleeding) is more fragile. Until an RCT is performed, physicians will have to decide on an individual basis and in shared decision with their patient whether or not to switch from their NOAC to a VKA. Regarding the results of the FRAIL-AF trial, it is interesting that the rate of major and clinically relevant non-major bleeding complications in the arm that switched to a NOAC continued to increase more over time compared to the arm that continued with a VKA (see Chapter 7, Figure 2).7 This may indicate that the increased bleeding risk of a NOAC compared to a VKA extends beyond just the switching moment and that frail older patients in general, including those with new-onset AF, are better off with a VKA than with a NOAC. Note that this is a precautionary statement: thorough research is needed in frail older patients with new-onset AF to avoid drawing preliminary and wrong conclusions. A fourth question is which NOAC has the best profile in terms of effectivity and safety. This question should be answered in a head-to-head comparison of individual NOACs in an RCT. This question becomes more important as age and frailty increase, because the balance between coagulation and bleeding then becomes increasingly fragile and the slightest variation in medication could just make the difference. THE CASE OF MRS. DE JONG, NINE MONTHS LATER January 2024 – Mrs. de Jong is 84 years old now. Her 63-year-old neighbour also has atrial fibrillation (AF) and during their weekly coffee appointment, he tells Mrs. de Jong that he received an invitation to join a phase III study for the factor XI inhibitor milvexian, a very promising new type of anticoagulant that might drastically reduce the risk of bleeding, while still providing balanced protection against ischaemic stroke. After hearing this news, Mrs. de Jong is hopeful that a factor XI inhibitor would also help her to get rid of those annoying nose bleeds and bruises on her skin. These got worse after she switched to a non-vitamin K antagonist oral anticoagulant (NOAC) prescribed by her cardiologist six months ago after being hospitalised for heart failure. In fact, these bleeds and bruises sometimes urges her to deliberately stop taking the NOAC tablet for a few days. Right away, she makes an appointment with her general practitioner (GP) to ask if she could 9
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