117 FRAIL-AF RANDOMISED CONTROLLED TRIAL: RESULTS TABLE 3: FIRST MAJOR OR CLINICALLY RELEVANT NON-MAJOR BLEEDING LOCATION PER TREATMENT ARM. Major bleeding CRNM bleeding Continue with VKA Switch to NOAC Continue with VKA Switch to NOAC Skin n (%) 10 (1.5%) 23 (3.5%) Oropharyngeal n (%) 1 (0.2%) 16 (2.3%) 19 (2.9%) Gastrointestinal n (%) 1 (0.2%) 9 (1.4%) 3 (0.5%) 8 (1.2%) Urogenital n (%) 11 (1.7%) 20 (3.0%) Braina n (%) 6 (0.9%) 7 (1.1%) Ophthalmic n (%) 1 (0.2%) 2 (0.3%) 3 (0.5%) Musculoskeletal n (%) 1 (0.2%) 4 (0.6%) 1 (0.2%) Lung n (%) 1 (0.2%) Other n (%) 3 (0.5%) 2 (0.3%) 3 (0.5%) 8 (1.2%) a Intracranial bleeding, subarachnoid haemorrhage, subdural bleeding, epidural bleeding. CRNM: clinically relevant non-major; NOAC: non vitamin-K antagonist oral anticoagulant; VKA: vitamin K antagonist. Secondary outcomes In the analysis where the two components of our primary outcome were assessed separately, the observed difference between both treatment arms seemed mainly driven by an increase in CRNM bleeding (see Table 2): the HR for major bleeding was 1.52 (95% CI 0.81–2.87) and the HR for CRNM bleeding was 1.77 (95% CI 1.24–2.52). The occurrence of all-cause thromboembolic events in the intervention arm was similar to the control arm: HR 1.26 (95% CI 0.60–2.61). The HR of switching from a VKA to a NOAC was 1.30 (95% CI 0.59–2.87) for the composite outcome of ischaemic or haemorrhagic stroke, and 0.96 (95% CI 0.64–1.45) for the outcome of all-cause mortality. 7
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