DOACs in AF ablation 47 Table 2. Primary and secondary end points Uninterrupted VKA N=520 Interrupted NOAC N=117 P-value Primary bleeding endpoints BARC 3–5 bleeding, n (%) 22 (4.2) 4 (3.4) 0.70 ISTH major bleeding, n (%) 45 (8.7) 7 (6.0) 0.34 Secondary bleeding endpoints Bleeding requiring medical attention that does not fit the criteria for types 3–5 (BARC 2), n (%) 43 (8.3) 3 (2.6) 0.03 Bleeding with hemoglobin drop of 30 to < 50 g/L or requiring transfusion (BARC 3a), n (%) 10 (1.9) 3 (2.6) 0.72 Bleeding with hemoglobin drop of ≥ 50 g/L, or requiring surgery or iv vasoactive agents, or cardiac tamponade (BARC 3b), n (%) 12 (2.3) 1 (0.9) 0.48 BARC 2–5 bleeding, n (%) 65 (12.5) 7 (6.0) 0.04 CRNMB, n (%) 20 (3.8) - 0.03 ISTH major bleeding and CRNMB, n (%) 65 (12.5) 7 (6.0) 0.04 Primary thromboembolic endpoint Stroke, TIA, or other systemic embolism, n (%) 3 (0.6) - 1.00 BARC = Bleeding Academic Research Consortium, CRNMB = clinically relevant non-major bleeding, ISTH = International Society on Thrombosis and Haemostasis, NOAC= novel oral anticoagulant, TIA = transient ischemic attack, VKA = vitamin K antagonist 3
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