CARDIOVASCULAR JOURNAL OF AFRICA • Volume 33, No 4, July/August 2022 188 AFRICA more than 10% of the patients at baseline. Table 1 describes the baseline patient characteristics. The median follow-up time was 213 (IQR: 119–477) days and the total follow up was 105 872 days. Fifty patients (20.6%) had a bleeding event, with the rate being 17.24 per 100 person-years (Table 2). Of these patients, 60% had minor bleeding events (Fig. 2). The incidence rate of all bleeding in females was 23.19 per 100 person-years, which was much higher compared to the overall bleeding rate of 17.24 in the whole cohort. The incidence rate of all bleeding among males was 11.51 per 100 person-years. The incidence rate among patients < 40 years was 65.57 per 100 person-years for all bleeding events and 30.26 per 100 personyears for CRNM and major events. In patients with PE, the incidence of overall bleeding was 16.08 per 100 person-years. Among patients with DVT only, it was 20.54 per 100 person-years. The most common anatomical site for major bleeding was the gastrointestinal system with 1.72 events per 100 personyears (Table 3). The overall incidence rate for major bleeding events was 3.79 per 100 person-years. Menorrhagia was the most common form of CRNM bleeding with an incidence rate of Table 1. Baseline patient characteristics Variables Number (%) (n = 243) Age, years 57 (45–71) Gender, female 123 (50.6) Co-morbidities 12 (4.9) Liver dysfunction 15 (6.4) Renal dysfunction 25 (10.3) Hypertension 77 (32.0) Diabetes 36 (15.1) Dyslipidaemia 40 (17.0) Cancer 25 (10.5) Stroke 12 (5.0) Index diagnosis Pulmonary embolism 191 (78.9) Lower-limb proximal DVT 106 (43.6) Lower-limb distal DVT 6 (2.5) Upper-limb DVT 3 (1.2) NOAC Apixaban 9 (3.7) Dabigatran 12 (4.9) Rivaroxaban 222 (91.4) DVT, deep venous thrombosis; NOAC, new oral anticoagulants. Table 2. Bleeding event incidence rates among patients with VTE according to age, gender and HAS-BLED score Characteristics No. of patients Patientyears Bleeding event Bleeding event rates per 100 person-years Any bleed Major CRNM Minor Any severity Major CRNM Minor All 243 290.06 50 11 9 30 17.24 3.79 3.10 10.34 Gender Male 120 147.73 17 5 3 9 11.51 3.38 2.03 6.09 Female 123 142.33 33 6 6 21 23.19 4.22 4.22 14.75 Age, years < 40 36 19.83 13 4 2 7 65.57 20.17 10.09 35.30 40–65 124 146.66 28 3 4 21 19.09 2.05 2.73 14.32 66–80 55 80.01 7 3 3 1 8.75 3.75 3.75 1.25 > 80 28 43.56 2 1 0 1 4.59 2.30 – 2.30 Index indication PE (± DVT) 191 230.12 37 10 7 21 16.08 4.35 3.04 9.13 DVT only 51 58.43 12 1 2 9 20.54 1.71 3.42 15.40 NOAC Rivaroxaban 222 268.27 46 9 8 29 17.15 3.35 2.98 10.81 Apixaban, dabigatran 21 21.79 4 2 1 1 18.36 9.18 4.59 4.59 Modified HAS-BLED score 0 101 106.37 26 4 4 18 24.44 3.76 3.76 16.92 1 52 68.93 9 2 0 7 13.06 2.90 – 10.16 2 44 56.67 9 2 4 3 15.88 3.53 7.06 5.29 ≥ 3 16 26.27 2 2 0 0 7.61 7.61 – – Modified HAS-BLED score 0 85 97 10 3 0 7 10.31 3.09 – 7.22 1 59 68.35 6 2 0 4 8.78 2.93 – 5.85 2 42 55.23 7 1 4 2 12.67 1.81 7.24 3.62 ≥ 3 16 26.27 2 2 0 0 7.61 7.61 – – HAS-BLED, hypertension, abnormal renal and liver functions, stroke history, prior major bleeding or predisposition to bleeding, labile INR, elderly age > 65 years, use of aspirin, clopidogrel, alcohol use; NOAC, new oral anticoagulants; PE, pulmonary embolism; DVT, deep-vein thrombosis; CRNM, clinically relevant non-major bleeding. Minor bleeding Major/CRNM bleeding 40% 60% Fig. 2. Proportions of patients with minor, major or clinically relevant non-major bleeding.
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