196 SUMMARY to identify the following patient characteristics that were found to be independently associated with a higher likelihood of receiving a VKA prescription rather than a NOAC prescription in patients with new-onset AF: higher age, heart failure, diabetes mellitus, vascular disease, and dementia.11 SWITCHING FROM A VITAMIN K ANTAGONIST TO A NON-VITAMIN K ANTAGONIST ORAL ANTICOAGULANT IN FRAIL OLDER PATIENTS WITH ATRIAL FIBRILLATION It is estimated that 1 in 25 individuals in the Netherlands is currently frail and old.13,14 AF is particularly common in the older population with a prevalence of 38% in the oldest and frailest population, namely nursing home residents.15 As shown in Chapter 5, the prevalence of AF in the Netherlands increased from 0.4% to 1.4% between 2008 and 2017.11 This is partly due to the ageing of the population. The number of frail older patients with AF is expected to increase further in the near future, as the ageing of the population continues in the coming years. Because evidence from RCTs in frail older AF patients is lacking and observational studies are sensitive to confounding bias, the FRAIL-AF trial was set up to investigate whether switching from a VKA to a NOAC compared to continuing a VKA reduces the number of major or clinically relevant non-major bleeding complications in frail older patients with AF. The comprehensive rationale and design of this trial are described in Chapter 6.16 In summary, the FRAIL-AF trial is an investigator-initiated, randomised controlled, pragmatic, multicentre, openlabel superiority trial.16 Frail older patients in an outpatient setting were included.16 To assess frailty, the validated Groningen Frailty Indicator (GFI) questionnaire was used, which scores frailty on several domains such as mobility, comorbidity, cognition and the psychosocial domain.16,17 Patients aged 75 years or older with a GFI score of ≥3, managed with a VKA for non-valvular AF, willing to switch from a VKA to a NOAC, and willing and able to provide written informed consent were eligible to participate in the FRAIL-AF trial.16 Patients with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 were excluded from randomisation.16 Eight Dutch thrombosis services provided the inclusion of the participants.16 Patients randomised to the intervention arm switched from a VKA to a NOAC.16 It was left to the treating physician, often the patient’s general practitioner, to decide which of the four NOACs was prescribed.16 Patients randomised to the control arm continued to receive a VKA (acenocoumarol or phenprocoumon) aiming at an INR target value between 2.0 and 3.0 with monitoring by the Dutch thrombosis services.16 The primary outcome was the composite of the first major or clinically relevant non-major bleeding complication following the definitions of the International Society on Thrombosis and Haemostasis.16,18,19 Secondary outcomes were thromboembolic events and all-cause mortality.16 The follow-up period was one year and all analyses were performed using a Cox regression analysis on an intention-to-treat basis.16
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