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.


Journal

International journal of cardiology
ISSN: 1874-1754
Titre abrégé: Int J Cardiol
Pays: Netherlands
ID NLM: 8200291

Informations de publication

Date de publication:
01 Jan 2024
Historique:
received: 27 07 2023
revised: 05 09 2023
accepted: 24 09 2023
medline: 4 12 2023
pubmed: 29 9 2023
entrez: 28 9 2023
Statut: ppublish

Résumé

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. 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. 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). 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.

Sections du résumé

BACKGROUND 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 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 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 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.

Identifiants

pubmed: 37769970
pii: S0167-5273(23)01391-8
doi: 10.1016/j.ijcard.2023.131398
pii:
doi:

Substances chimiques

Warfarin 5Q7ZVV76EI
Anticoagulants 0

Types de publication

Observational Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

131398

Informations de copyright

Copyright © 2023. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Nicoletta Erba (N)

Medical Division, Emergency, ONG Onlus, Milan, Italy; Salam Centre for Cardiac Surgery, Khartoum, Sudan.

Alberto Tosetto (A)

Hematology Department, San Bortolo Hospital, Vicenza, Italy.

Suha Abdelwahab Abdallah (SA)

Medical Division, Emergency, ONG Onlus, Milan, Italy; Salam Centre for Cardiac Surgery, Khartoum, Sudan.

Martin Langer (M)

Medical Division, Emergency, ONG Onlus, Milan, Italy; Salam Centre for Cardiac Surgery, Khartoum, Sudan.

Elena Giovanella (E)

Medical Division, Emergency, ONG Onlus, Milan, Italy; Salam Centre for Cardiac Surgery, Khartoum, Sudan.

Salvatore Lentini (S)

Medical Division, Emergency, ONG Onlus, Milan, Italy; Salam Centre for Cardiac Surgery, Khartoum, Sudan.

Franco Masini (F)

Medical Division, Emergency, ONG Onlus, Milan, Italy; Salam Centre for Cardiac Surgery, Khartoum, Sudan.

Alessandro Mocini (A)

Medical Division, Emergency, ONG Onlus, Milan, Italy; Salam Centre for Cardiac Surgery, Khartoum, Sudan.

Gennarina Portella (G)

Medical Division, Emergency, ONG Onlus, Milan, Italy; Salam Centre for Cardiac Surgery, Khartoum, Sudan.

Alessandro Cristian Salvati (AC)

Medical Division, Emergency, ONG Onlus, Milan, Italy; Salam Centre for Cardiac Surgery, Khartoum, Sudan.

Alessandro Squizzato (A)

Research Center on Thromboembolic Disorders and Antithrombotic Therapies, ASST Lariana, University of Insubria, Como, Italy.

Sophie Testa (S)

Hemostasis and Thrombosis Center, Laboratory Medicine Department, ASST Cremona, Cremona, Italy.

Gregory Y H Lip (GYH)

Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Department of Clinical Medicine, Liverpool, UK; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.

Daniela Poli (D)

Thrombosis Centre, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy. Electronic address: polida@aou-careggi.toscana.it.

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Classifications MeSH