116 CHAPTER 7 TABLE 2: PRIMARY AND SECONDARY OUTCOMES. Continue with VKA Switch to NOAC Hazard Ratio (95% CI) n (%) number of events/100 patient years (95% CI) n (%) number of events/100 patient years (95% CI) Primary outcome Major or CRNM bleeding 62 (9.4%) 10.5 (8.0-13.4) 101 (15.3%) 17.8 (14.5-21.6) 1.69 (1.23-2.32) Secondary outcomes Major bleeding 16 (2.4%) 2.6 (1.5-4.2) 24 (3.6%) 3.9 (2.5-5.9) 1.52 (0.81-2.87) CRNM bleeding 49 (7.4%) 8.2 (6.1-10.9) 84 (12.7%) 14.6 (11.7-18.1) 1.77 (1.24-2.52) Thromboembolic events 13 (2.0%) 2.1 (1.1-3.6) 16 (2.4%) 2.6 (1.5-4.3) 1.26 (0.60-2.61) Composite of thromboembolic events and major or CRNM bleeding 73 (11.0%) 12.4 (9.8-15.6) 115 (17.4%) 20.6 (17.0-24.7) 1.65 (1.23-2.21) Composite of ischaemic and haemorrhagic stroke 11 (1.7%) 1.8 (0.9-3.2) 14 (2.1%) 2.3 (1.3-3.8) 1.30 (0.59-2.87) All-cause mortality 46 (7.0%) 7.4 (5.4-9.8) 44 (6.7%) 7.1 (5.2-9.5) 0.96 (0.64-1.45) CI: confidence interval; CRNM: clinically relevant non-major; NOAC: non vitamin-K antagonist oral anticoagulant; VKA: vitamin K antagonist.
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