CARDIOVASCULAR JOURNAL OF AFRICA • Volume 33, No 4, July/August 2022 AFRICA 189 1.03 per 100 person-years. Table 3 illustrates the proportions of the different forms of bleeding. Although females had a higher incidence of major and CRNM bleeding compared to males (8.43 vs 5.4 per 100 person-years), this was not statistically significant (p = 0.33, CI = 0.64–3.81) (Table 4). Younger age was associated with a higher incidence rate of CRNM and major bleeding (p = 0.0001, CI = 2.13–18.86) (Table 4). Concomitant use of aspirin and other antiplatelets (p = 0.0003, CI = 2.06–38.33) and anaemia (p = 0.005, CI = 1.37– 10.39) also increased the risk of major and CRNM bleeding. There was a trend towards an association between dyslipidaemia and increased risk of CRNM and major bleeding events (p = 0.08, CI = 0.88–5.56). The incidence rate of major or CRNM bleeding among patients with a modified HAS-BLED score of two was 10.59 per 100 person-years. Among those with a score of three points or higher, the incidence rate was 7.61 per 100 person-years. Discussion This was a single-centre, retrospective review of patients with VTE on NOACs, focusing on bleeding outcomes. The study found that the incidence rate for all bleeding was 17.24 per 100 person-years, with the most common site of major bleeding being the gastrointestinal system, with an incidence rate of 1.72 per 100 person-years. Table 3. Treatment: emergent clinical outcomes Bleeding events by site No. of events Proportion (%) Incidence rate Any bleed Menorrhagia 24 38 8.27 GI* 10 16 3.45 Skin 9 14 3.10 Nasal 7 11 2.41 Gums 4 6 1.38 Respiratory 4 6 1.38 Muscle 3 5 1.03 Haematuria 3 5 1.03 Intracranial 0 0 – All 64 100 22.06 Minor bleed Menorrhagia 18 42 6.21 Skin 9 21 3.10 Nasal 6 14 2.07 GI 4 9 1.38 Gums 4 9 1.38 Respiratory 1 2 0.34 Haematuria 1 2 0.34 All 43 100 14.82 CRNM bleed Menorrhagia 3 43 1.03 Haematuria 2 29 0.69 GI 1 14 0.34 Nasal 1 14 0.34 All 7 100 2.41 Major bleed GI 5 36 1.72 Menorrhagia 3 21 1.03 Muscle 3 21 1.03 Respiratory 3 21 1.03 All 14 100 4.83 Major and/or CRNM GI 6 29 2.07 Menorrhagia 6 29 2.07 Muscle 3 14 1.03 Respiratory 3 14 1.03 Haematuria 2 10 0.69 Nasal 1 5 0.34 All 21 100 7.24 *Bleeding event rates per 100 person-years. Patients may have experienced more than one type of bleeding (major and CRNM) within different sites, and so these counts are not mutually exclusive. Menorrhagia was defined as abnormally prolonged or heavy menstrual bleeding. CRNM, clinically relevant non-major bleeding; GI, gastrointestinal. Table 4. Factors associated with bleeding Factors associated with significant bleeding events* (major + CRNM) Number Person years Major events Rate/100 personyears RR 95% CI p-value Gender Male 120 147.7 8 5.42 Ref Female 123 142.3 12 8.43 1.56 0.64–3.81 0.33 Age < 40 36 19.83 6 30.26 6.34 2.13–18.86 0.0001 40–65 124 146.66 7 4.77 Ref 66-80 55 80.01 6 7.50 1.57 0.53–4.67 0.41 > 80 28 43.56 1 2.30 0.48 0.06–3.91 0.48 Modified HAS-BLED score 0 101 106.37 8 7.52 Ref 1 62 68.93 2 2.90 0.39 0.08–1.81 0.21 2 44 56.66 6 10.59 1.41 0.48–4.05 0.52 3 or higher 16 26.27 2 7.61 1.01 0.22–4.77 0.99 Aspirin and other antiplatelets No 230 282.57 18 6.37 Ref Yes 7 3.53 2 56.66 8.89 2.06–38.33 0.0003 Anaemia (Hb < 10 g/dl) No 219 266.53 15 5.63 Ref Yes 24 23.52 5 21.26 3.77 1.37–10.39 0.005 Heart failure No 231 259.07 17 6.56 Ref Yes 12 30.99 3 9.68 1.47 0.43–5.03 0.53 Hepatic dysfunction No 228 267.96 16 5.97 Ref Yes 15 14.27 2 14.02 2.34 0.53–10.21 0.24 Renal dysfunction No 218 247.66 17 6.86 Ref Yes 25 42.4 3 7.08 1.03 0.30–3.52 0.96 Hypertension No 164 179.12 12 6.70 Ref Yes 77 108.96 8 7.34 1.1 0.45–2.68 0.84 Dyslipidaemia No 196 224.11 12 5.35 Ref Yes 40 58.67 7 11.93 2.22 0.88–5.65 0.08 Cancer No 214 259.4 16 6.17 Ref Yes 25 26.86 3 11.17 1.81 0.52–6.21 0.34 Stroke No 230 278.13 19 6.83 Ref Yes 12 10.42 1 9.60 1.4 0.19–10.49 0.74 CRNM, clinically relevant non-major bleeding; RR, relative risk; Hb, haemaglobin; 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. *The co-morbidities were defined by the physician-directed diagnosis at the start of therapy.
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