Assessment of bleeding events in patients receiving DOACs with or without statins to treat venous thromboembolism: insights from the RIETE registry.
Details
State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_DFF21E2E884E
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Assessment of bleeding events in patients receiving DOACs with or without statins to treat venous thromboembolism: insights from the RIETE registry.
Journal
BMJ open
Working group(s)
RIETE Investigators
Contributor(s)
Monreal M., Prandoni P., Brenner B., Farge-Bancel D., Barb R., Micco P.D., Bertoletti L., Schellong S., Tzoran I., Reis A., Bosevski M., Bounameaux H., Malý R., Verhamme P., Caprini J.A., Bui H.M., Adarraga M.D., Alberich-Conesa A., Aibar J., Alda-Lozano A., Alfonso J., Amado C., Angelina-García M., Arcelus J.I., Ballaz A., Barba R., Barbagelata C., Barrón M., Barrón-Andrés B., Beddar-Chaib F., Blanco-Molina A., Caballero J.C., Carrillo-Alonso J., Castellanos G., Chasco L., Criado J., De Ancos C., Del Toro J., Demelo-Rodríguez P., De Juana-Izquierdo C., Díaz-Pedroche M.C., Díaz-Peromingo J.A., Dubois-Silva A., Escribano J.C., Falgá C., Farfán-Sedano A.I., Fernández-Aracil C., Fernández-Capitán C., Fernández-Jiménez B., Fernández-Reyes J.L., Fidalgo M.A., Francisco I., Gabara C., Galeano-Valle F., García-Bragado F., García-González C., García-Ortega A., Gavín-Sebastián O., Gil-De Gómez M.A., Gil-Díaz A., Gómez-Cuervo C., González-Munera A., Grau E., Guirado L., Gutiérrez J., Hernández-Blasco L., Jara-Palomares L., Jaras M.J., Jiménez D., Jou I., Joya M.D., Lecumberri R., Llamas P., Lobo J.L., López-Jiménez L., López-Miguel P., López-Brull H., López-Núñez J.J., López-Ruiz A., LópezSáez J.B., Lorenzo A., Lumbierres M., Madridano O., Maestre A., Marchena P.J., Marcos M., Martín Del Pozo M., Martín-Martos F., Martínez-Prado R., Maza J.M., Mena E., Mercado M.I., Moisés J., Molino A., Monreal M., Morales M.V., Navas M.S., Nieto J.A., Núñez-Fernández M.J., Olid M., Ordieres-Ortega L., Ortiz M., Osorio J., Otálora S., Otero R., Pacheco-Gómez N., Pagán J., Palomeque A.C., Paredes E., Parra-Caballero P., Parra-Rosado P., Pedrajas J.M., Pérez-Ductor C., Pérez-Pinar M., Pérez-Jacoiste M.A., Peris M.L., Pesce M.L., Porras J.A., Puchades R., Rivera-Cívico F., Rodríguez-Cobo A., Romero-Brugera M., Ruiz-Artacho P., Ruiz-Giménez N., Ruiz-Ruiz J., Salgueiro G., Sancho T., Sendín V., Sigüenza P., Soler S., Steinherr A., Suárez-Fernández S., Tirado R., TorrentsVilar A., Torres M.I., Trujillo-Santos J., Uresandi F., Valle R., Varona J.F., Villalobos A., Villares P., Ay C., Nopp S., Pabinger I., Van Edom C., Verhamme P., Verstraete A., Hhb Y., Montenegro A.C., Morales S.N., Roa J., Hirmerova J., Malý R., Bertoletti L., BuraRiviere A., Catella J., Chopard R., Couturaud F., Espitia O., Grange C., Le Mao R., Leclercq B., Mahé I., Moustafa F., Plaisance L., Sarlon-Bartoli G., Suchon P., Versini E., Schellong S., Brenner B., Kenet G., Tzoran I., Sadeghipour P., Rashidi F., Abenante A., Barillari G., Basaglia M., Bertoni M., Bilora F., Brandolin B., Ciammaichella M., Colaizzo D., Dentali F., Di Micco P., Grandone E., Imbalzano E., Negro F., Pesavento R., Poz A., Prandoni P., Siniscalchi C., Taflaj B., Tufano A., Visonà A., Zalunardo B., Skride A., Kigitovica D., Fonseca S., Marques R., Meireles J., Pinto S., Bosevski M., Zdraveska M., Bounameaux H., Mazzolai L., Aujayeb A., Caprini J.A., Weinberg I., Bui H.M.
ISSN
2044-6055 (Electronic)
ISSN-L
2044-6055
Publication state
Published
Issued date
22/10/2024
Peer-reviewed
Oui
Volume
14
Number
10
Pages
e085401
Language
english
Notes
Publication types: Journal Article ; Observational Study ; Multicenter Study
Publication Status: epublish
Publication Status: epublish
Abstract
To evaluate the impact of coadministering statins with direct oral anticoagulants (DOACs) on the risk of major bleeding events in patients with venous thromboembolism (VTE).
Observational cohort analysis based on a multicentre international registry.
Data were extracted from the Registro Informatizado de Enfermedad TromboEmbolica Registry, which involves 205 centres across 27 countries.
A total of 73 659 patients diagnosed with VTE were classified based on their anticoagulant therapy (DOACs) versus low-molecular-weight heparin (LMWH) or vitamin K antagonists (VKAs) and concurrent use of statins.
Multivariable Cox proportional hazards models adjusted for confounding variables to assess the risk of major bleeding events stratified by the type of anticoagulant use and statin use.
From October 2013 to February 2023, 73 659 patients were recruited: 2573 were statin users on DOACs, 14 090 were statin users on LMWH or VKA therapy, 10 088 were non-statin users on DOACs and 46 908 were non-statin users on LMWH or VKA therapy. Statin users were 10 years older and more likely to have hypertension, diabetes, renal failure or prior artery disease. During anticoagulation (median, 187 days), 1917 patients (2.6%) suffered major bleeding. Rates of major bleeding per 100 patient-years were 2.33 (95% CI 1.72 to 3.09), 3.75 (95% CI 3.43 to 4.10), 1.39 (95% CI 1.13 to 1.69) and 3.10 (95% CI 2.93 to 3.27), respectively. On multivariable analysis, patients treated with DOACs had a significantly lower risk of major bleeding compared with those on LMWH or VKA therapy (adjusted HR 0.59; 95% CI 0.48 to 0.74). The adjusted HR in statin users versus non-users was 1.03 (95% CI 0.92 to 1.14), while in statin users on DOACs versus the rest of patients, it was 1.18 (95% CI 0.79 to 1.76).
In patients with VTE receiving statins, long-term anticoagulation with DOACs was associated with a reduced risk of major bleeding, regardless of the statin use. These findings support the safety profile of DOACs over VKAs or LMWH in the management of VTE in patients requiring statins.
Observational cohort analysis based on a multicentre international registry.
Data were extracted from the Registro Informatizado de Enfermedad TromboEmbolica Registry, which involves 205 centres across 27 countries.
A total of 73 659 patients diagnosed with VTE were classified based on their anticoagulant therapy (DOACs) versus low-molecular-weight heparin (LMWH) or vitamin K antagonists (VKAs) and concurrent use of statins.
Multivariable Cox proportional hazards models adjusted for confounding variables to assess the risk of major bleeding events stratified by the type of anticoagulant use and statin use.
From October 2013 to February 2023, 73 659 patients were recruited: 2573 were statin users on DOACs, 14 090 were statin users on LMWH or VKA therapy, 10 088 were non-statin users on DOACs and 46 908 were non-statin users on LMWH or VKA therapy. Statin users were 10 years older and more likely to have hypertension, diabetes, renal failure or prior artery disease. During anticoagulation (median, 187 days), 1917 patients (2.6%) suffered major bleeding. Rates of major bleeding per 100 patient-years were 2.33 (95% CI 1.72 to 3.09), 3.75 (95% CI 3.43 to 4.10), 1.39 (95% CI 1.13 to 1.69) and 3.10 (95% CI 2.93 to 3.27), respectively. On multivariable analysis, patients treated with DOACs had a significantly lower risk of major bleeding compared with those on LMWH or VKA therapy (adjusted HR 0.59; 95% CI 0.48 to 0.74). The adjusted HR in statin users versus non-users was 1.03 (95% CI 0.92 to 1.14), while in statin users on DOACs versus the rest of patients, it was 1.18 (95% CI 0.79 to 1.76).
In patients with VTE receiving statins, long-term anticoagulation with DOACs was associated with a reduced risk of major bleeding, regardless of the statin use. These findings support the safety profile of DOACs over VKAs or LMWH in the management of VTE in patients requiring statins.
Keywords
Humans, Venous Thromboembolism/drug therapy, Venous Thromboembolism/epidemiology, Hemorrhage/chemically induced, Hemorrhage/epidemiology, Female, Male, Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects, Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use, Registries, Aged, Middle Aged, Anticoagulants/adverse effects, Anticoagulants/therapeutic use, Heparin, Low-Molecular-Weight/therapeutic use, Heparin, Low-Molecular-Weight/adverse effects, Vitamin K/antagonists & inhibitors, Proportional Hazards Models, Drug Therapy, Combination, Aged, 80 and over, Administration, Oral, CLINICAL PHARMACOLOGY, GENERAL MEDICINE (see Internal Medicine), INTERNAL MEDICINE, VASCULAR MEDICINE
Pubmed
Open Access
Yes
Create date
28/10/2024 14:00
Last modification date
29/10/2024 7:34
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