TY - JOUR
T1 - Association of sex with major bleeding risks in sub-Saharian anticoagulated patients with mechanical heart valves: A cohort study from the Khartoum Emergency Salam Centre
AU - Erba, Nicoletta
AU - Tosetto, Alberto
AU - Abdallah, Suha Abdelwahab
AU - Langer, Martin
AU - Giovanella, Elena
AU - Lentini, Salvatore
AU - Masini, Franco
AU - Mocini, Alessandro
AU - Portella, Gennarina
AU - Salvati, Alessandro Cristian
AU - Squizzato, Alessandro
AU - Testa, Sophie
AU - Lip, Gregory Y. H.
AU - Poli, Daniela
N1 - Copyright © 2023. Published by Elsevier B.V.
PY - 2024/1/1
Y1 - 2024/1/1
N2 - BACKGROUND: Rheumatic heart disease (RHD) with mechanical heart valve (MHV) replacement is common in Africa. However, MHV requires lifelong anticoagulation that could have a particular impact in women in reproductive age.METHODS: We report data of a prospective observational cohort study conducted between August 2018 and September 2019 in MHV patients in the Salam Centre for Cardiac Surgery built in Khartoum by Emergency, an Italian Non-Governmental Organization, to evaluate bleeding risk, its associated determinants, and the impact of lifelong anticoagulation in fertile women.RESULTS: We studied 3647 patients (median age 25.1 years; 53.9% female). During follow-up [median time 1.1 (0.1-1.2) years], we recorded 85 major bleedings (rate 2.16 × 100 pt-years), Major bleedings occurred more frequently among women (64/85 cases, 75.3%; rate 3.0 × 100 pt-years), compared to men (21/85 cases, 24.7%; rate 1.16 × 100 pt-years) (RR 2.6; 95% CI 1.6-4.5; p = 0.0001). Multivariate analysis was performed to identify variables associated with major bleeding, and female sex was the only risk factor significantly associated, whereas aspirin treatment and higher INR target showed a non-significant trend for higher bleeding risk. Thirty-two/85 (37.6%) of major bleedings were metrorrhagias. When we calculate the incidence of major bleedings after the exclusion of gynecological events, no sex differences in the bleeding risk were found (HR 1.3, 95% CI 0.8-2.3; p = 0.3).CONCLUSIONS: Bleeding risk of young MHV patients on oral anticoagulant therapy is higher among women, mainly due to metrorrhagia. Women in the reproductive life are at high risk for gynecological bleeding when treated with anticoagulants.
AB - BACKGROUND: Rheumatic heart disease (RHD) with mechanical heart valve (MHV) replacement is common in Africa. However, MHV requires lifelong anticoagulation that could have a particular impact in women in reproductive age.METHODS: We report data of a prospective observational cohort study conducted between August 2018 and September 2019 in MHV patients in the Salam Centre for Cardiac Surgery built in Khartoum by Emergency, an Italian Non-Governmental Organization, to evaluate bleeding risk, its associated determinants, and the impact of lifelong anticoagulation in fertile women.RESULTS: We studied 3647 patients (median age 25.1 years; 53.9% female). During follow-up [median time 1.1 (0.1-1.2) years], we recorded 85 major bleedings (rate 2.16 × 100 pt-years), Major bleedings occurred more frequently among women (64/85 cases, 75.3%; rate 3.0 × 100 pt-years), compared to men (21/85 cases, 24.7%; rate 1.16 × 100 pt-years) (RR 2.6; 95% CI 1.6-4.5; p = 0.0001). Multivariate analysis was performed to identify variables associated with major bleeding, and female sex was the only risk factor significantly associated, whereas aspirin treatment and higher INR target showed a non-significant trend for higher bleeding risk. Thirty-two/85 (37.6%) of major bleedings were metrorrhagias. When we calculate the incidence of major bleedings after the exclusion of gynecological events, no sex differences in the bleeding risk were found (HR 1.3, 95% CI 0.8-2.3; p = 0.3).CONCLUSIONS: Bleeding risk of young MHV patients on oral anticoagulant therapy is higher among women, mainly due to metrorrhagia. Women in the reproductive life are at high risk for gynecological bleeding when treated with anticoagulants.
KW - Bleeding risk
KW - Gender differences
KW - Mechanical heart valve
KW - Warfarin
KW - Women
UR - http://www.scopus.com/inward/record.url?scp=85173146498&partnerID=8YFLogxK
U2 - 10.1016/j.ijcard.2023.131398
DO - 10.1016/j.ijcard.2023.131398
M3 - Journal article
C2 - 37769970
SN - 0167-5273
VL - 394
JO - International Journal of Cardiology
JF - International Journal of Cardiology
M1 - 131398
ER -