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  2. Keyword: Factor Xa Inhibitors
ABC
Editorial

Challenges in Performing Real-World Evidence Studies in Low-Middle Income Countries: the EdoBRA Study

Ayrton Roberto Massaro

In 1991, Wolf et al. on the Framingham study demonstrated that atrial fibrillation (AF) constitutes an independent risk factor for ischemic stroke. Hart et al., in a meta-analysis, confirmed warfarin’s effectiveness in lowering stroke risk by 64% in AF patients. A slight increase in major extracranial hemorrhage was observed, which did not impact overall efficacy. Unpredictable pharmacokinetics, interactions, and INR monitoring needs have limited warfarin use. In low-middle income countries (LMICs) like Brazil, socio-economic disparities affected warfarin use in AF patients.

Direct oral anticoagulants (DOACs) were introduced to overcome the barriers associated with warfarin. All DOACs showed strong stroke prevention compared to warfarin. Edoxaban in the ENGAGE AF-TIMI 48 trial was non-inferior to warfarin in safety and superior in preventing hemorrhagic strokes. Latin American patients showed higher hemorrhage and mortality rates compared to other regions. In addition, considerations of cost, renal monitoring, DOACs in AF subpopulations, and reversal agents for hemorrhage highlight the importance of tailoring therapy based on patient-specific risks.

[…]

  • Atrial Fibrillation
  • Factor Xa Inhibitors
  • Stroke
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Creative Commons Attribution (CC BY) Creative Commons license
28/07/2025 DOI: 10.36660/abc.20250353i Views 3
ABC
Editorial

Advancing the Use of Direct Oral Anticoagulants in Left Ventricular Thrombus Management

Pedro E. P. Carvalho

Direct oral anticoagulants (DOACs) are preferred over Vitamin K Antagonists (VKAs) in numerous clinical scenarios, such as preventing thromboembolic events in patients with atrial fibrillation and treating venous thromboembolism.– In contrast, DOACs are contraindicated in patients with mechanical heart valves, valvular AF due to mitral stenosis, and antiphospholipid syndrome.– In patients with left ventricular thrombus (LVT), however, the efficacy and safety of DOACs remain uncertain.

LVT is a common complication following an acute myocardial infarction (MI). The incidence of LVT post-acute MI has declined due to increased primary percutaneous coronary intervention (PCI) and advanced antithrombotic therapies. In the primary PCI era, LVT incidence is up to 6.3% in STEMI patients, rising to 19.2% in those with anterior STEMI and reduced left ventricular ejection fraction. Data from the SWEDEHEART registry indicated an incidence as high as 38%, suggesting underestimation and the need for follow-up to assess LVT formation in these patients. In addition, the choice of imaging modality significantly impacts LVT detection, with cardiac magnetic resonance having higher sensitivity compared with echocardiography. Therefore, there is an unmet need for LVT prevention, detection, and treatment.

[…]

  • Factor Xa Inhibitors
  • Myocardial Infarction
  • Venous Thromboembolism
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Creative Commons Attribution (CC BY) Creative Commons license
22/11/2024 DOI: 10.36660/abc.20240409i Views 1
Direct Oral Anticoagulants versus Vitamin K Antagonists for Left Ventricular Thrombus: A Meta-Analysis with Trial Sequential Analysis
ABC
Original Article

Direct Oral Anticoagulants versus Vitamin K Antagonists for Left Ventricular Thrombus: A Meta-Analysis with Trial Sequential Analysis

Eric Pasqualotto et al. Douglas Mesadri Gewehr Rafael Oliva Morgado Ferreira Matheus Pedrotti Chavez … Caroliny Hellen Silva Sara Almeida Cruz Jhonny Limachi-Choque Amanda Park Mário Sérgio Soares de Azeredo Coutinho Luiz Fernando Kubrusly

Abstract

Background

Vitamin K antagonists (VKAs) are the recommended first-line treatment for left ventricular thrombus (LVT); however, direct oral anticoagulants (DOACs) have been considered an alternative therapy.

Objectives

To evaluate the efficacy and safety of DOACs compared with VKAs therapy in patients with LVT.

Methods

PubMed, Embase, and Cochrane were systematically searched for randomized clinical trials or cohort studies that compared DOACs versus VKAs for LVT. Risk ratios (RRs) were computed for binary endpoints, with 95% confidence intervals (95% CIs). Statistical significance was defined as p value < 0.05.

Results

A total of 4 randomized clinical trials and 29 cohort studies were included, with 4,450 patients assigned to either DOACs or VKAs. There was no significant difference between groups for stroke or systemic embolic (SSE) events (RR 0.84; 95% CI 0.65 to 1.07; p = 0.157), stroke (RR 0.73; 95% CI 0.48 to 1.11; p = 0.140), systemic embolic (SE) events (RR 0.69; 95% CI 0.40 to 1.17; p = 0.166), thrombus resolution (RR 1.05; 95% CI 0.99 to 1.11; p = 0.077), any bleeding (RR 0.78; 95% CI 0.60 to 1.00; p = 0.054), clinically relevant bleeding (RR 0.69; 95% CI 0.46 to 1.03; p = 0.066), minor bleeding (RR 0.73; 95% CI 0.43 to 1.23; p = 0.234), major bleeding (RR 0.87; 95% CI 0.42 to 1.80; p = 0.705), and all-cause mortality (RR 1.05; 95% CI 0.79 to 1.39; p = 0.752). Compared with VKAs, rivaroxaban significantly reduced SSE events (RR 0.35; 95% CI 0.16 to 0.91; p = 0.029) and SE events (RR 0.39; 95% CI 0.16 to 0.95; p = 0.037).

Conclusions

DOACs had a similar rate of thromboembolic and hemorrhagic events, as well as thrombus resolution, compared to VKAs in the treatment of LVTs. Rivaroxaban therapy had a significant reduction in thromboembolic events, compared to VKAs.

  • Factor Xa Inhibitors
  • Thrombosis
  • Warfarin
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Creative Commons Attribution (CC BY) Creative Commons license
26/07/2024 DOI: 10.36660/abc.20230738i Views 1
Chronic Anticoagulation in Patients with Atrial Fibrillation and COVID-19: A Systematic Review and Meta-Analysis
ABC
Original Article

Chronic Anticoagulation in Patients with Atrial Fibrillation and COVID-19: A Systematic Review and Meta-Analysis

Isabela Landsteiner et al. Jonathan A. Pinheiro Nicole Felix Douglas Mesadri Gewehr Rhanderson Cardoso

Abstract

Background:

Coronavirus disease 2019 (COVID-19) is associated with hypercoagulability. It remains uncertain whether ongoing anticoagulation for atrial fibrillation (AF) in patients who later contract COVID-19 improves clinical outcomes.

Objectives:

To compare chronic oral anticoagulation with no previous anticoagulation in patients with AF who contracted a COVID-19 infection concerning the outcomes of all-cause mortality, COVID-19 mortality, intensive care unit (ICU) admission, and hospitalization.

Methods:

We systematically searched PubMed, Embase, and Cochrane Library for eligible studies from inception to December 2022. We included studies comparing COVID-19 outcomes in patients with versus without prior chronic anticoagulation for AF. Risk ratios (RR) with 95% confidence intervals (CI) were pooled with a random-effects model. The level of significance was set at p < 0.05. Quality assessment and risk of bias were performed according to Cochrane recommendations.

Results:

Ten studies comprising 1,177,858 patients with COVID-19 and AF were identified, of whom 893,772 (75.9%) were on prior chronic anticoagulation for AF. In patients with COVID-19, being on chronic anticoagulation for AF significantly reduced all-cause mortality (RR 0.75; 95% CI 0.57 to 0.99; p = 0.048; I = 89%) and COVID-19-related mortality (RR 0.76; 95% CI 0.72 to 0.79; p < 0.001; I = 0%) when compared with no prior anticoagulation. In contrast, there was no difference between groups regarding hospitalization (RR 1.08; 95% CI 0.82 to 1.41; p = 0.587; I = 95%) or ICU admission (RR 0.86; 95% CI 0.68 to 1.09; p = 0.216; I = 69%).

Conclusions:

In this meta-analysis, chronic anticoagulation for patients with AF who contracted COVID-19 was associated with significantly lower rates of all-cause mortality and COVID-19-related mortality as compared with no previous anticoagulation.

  • Anticoagulants
  • Atrial Fibrillation
  • COVID-19
  • Factor Xa Inhibitors
  • Vitamin K
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Creative Commons Attribution (CC BY) Creative Commons license
26/04/2024 DOI: 10.36660/abc.20230470i

How to cite this article

EndNote RIS

Electronic Document Format (Vancouver)

Massaro AR. Challenges in Performing Real-World Evidence Studies in Low-Middle Income Countries: the EdoBRA Study. Arquivos Brasileiros de Cardiologia 2025;122(4):e20250353.

Electronic Document Format (ABNT)

Massaro, Ayrton Roberto. Challenges in Performing Real-World Evidence Studies in Low-Middle Income Countries: the EdoBRA Study. Arquivos Brasileiros de Cardiologia, v. 122, n. 4, e20250353, Jul. 2025.

Electronic Document Format (APA)

Massaro, A. R. (2025). Challenges in Performing Real-World Evidence Studies in Low-Middle Income Countries: the EdoBRA Study. Arquivos Brasileiros de Cardiologia, 122(4), e20250353.

Electronic Document Format (ISO)

Massaro, Ayrton Roberto. Challenges in Performing Real-World Evidence Studies in Low-Middle Income Countries: the EdoBRA Study. Arquivos Brasileiros de Cardiologia [online]. 2025, vol. 122, n. 4, [cited 2026-10-14], e20250353. Available from: <https://journals.cardiol.br/en/article/challenges-in-performing-real-world-evidence-studies-in-low-middle-income-countries-the-edobra-study/>. ISSN 0066-782X

EndNote RIS

Electronic Document Format (Vancouver)

Carvalho PEP. Advancing the Use of Direct Oral Anticoagulants in Left Ventricular Thrombus Management. Arquivos Brasileiros de Cardiologia 2024;121(7):e20240409.

Electronic Document Format (ABNT)

Carvalho, Pedro E. P.. Advancing the Use of Direct Oral Anticoagulants in Left Ventricular Thrombus Management. Arquivos Brasileiros de Cardiologia, v. 121, n. 7, e20240409, Nov. 2024.

Electronic Document Format (APA)

Carvalho, P. E. P. (2024). Advancing the Use of Direct Oral Anticoagulants in Left Ventricular Thrombus Management. Arquivos Brasileiros de Cardiologia, 121(7), e20240409.

Electronic Document Format (ISO)

Carvalho, Pedro E. P.. Advancing the Use of Direct Oral Anticoagulants in Left Ventricular Thrombus Management. Arquivos Brasileiros de Cardiologia [online]. 2024, vol. 121, n. 7, [cited 2026-10-14], e20240409. Available from: <https://journals.cardiol.br/en/article/advancing-the-use-of-direct-oral-anticoagulants-in-left-ventricular-thrombus-management/>. ISSN 0066-782X

EndNote RIS

Electronic Document Format (Vancouver)

Pasqualotto E, Gewehr DM, Ferreira ROM, Chavez MP, Silva CH, Cruz SA, Limachi-Choque J, et al. Direct Oral Anticoagulants versus Vitamin K Antagonists for Left Ventricular Thrombus: A Meta-Analysis with Trial Sequential Analysis. Arquivos Brasileiros de Cardiologia 2024;121(7):e20230738.

Electronic Document Format (ABNT)

Pasqualotto, Eric; Gewehr, Douglas Mesadri; Ferreira, Rafael Oliva Morgado; Chavez, Matheus Pedrotti; Silva, Caroliny Hellen; Cruz, Sara Almeida; Limachi-Choque, Jhonny; Park, Amanda; Coutinho, Mário Sérgio Soares de Azeredo; Kubrusly, Luiz Fernando. Direct Oral Anticoagulants versus Vitamin K Antagonists for Left Ventricular Thrombus: A Meta-Analysis with Trial Sequential Analysis. Arquivos Brasileiros de Cardiologia, v. 121, n. 7, e20230738, Jul. 2024.

Electronic Document Format (APA)

Pasqualotto, E., Gewehr, D. M., Ferreira, R. O. M., Chavez, M. P., Silva, C. H., Cruz, S. A., Limachi-Choque, J., Park, A., Coutinho, M. S. S. A., & Kubrusly, L. F. (2024). Direct Oral Anticoagulants versus Vitamin K Antagonists for Left Ventricular Thrombus: A Meta-Analysis with Trial Sequential Analysis. Arquivos Brasileiros de Cardiologia, 121(7), e20230738.

Electronic Document Format (ISO)

Pasqualotto, Eric and Gewehr, Douglas Mesadri and Ferreira, Rafael Oliva Morgado and Chavez, Matheus Pedrotti and Silva, Caroliny Hellen and Cruz, Sara Almeida and Limachi-Choque, Jhonny and Park, Amanda and Coutinho, Mário Sérgio Soares de Azeredo and Kubrusly, Luiz Fernando. Direct Oral Anticoagulants versus Vitamin K Antagonists for Left Ventricular Thrombus: A Meta-Analysis with Trial Sequential Analysis. Arquivos Brasileiros de Cardiologia [online]. 2024, vol. 121, n. 7, [cited 2026-10-14], e20230738. Available from: <https://journals.cardiol.br/en/article/direct-oral-anticoagulants-versus-vitamin-k-antagonists-for-left-ventricular-thrombus-a-meta-analysis-with-trial-sequential-analysis/>. ISSN 0066-782X

EndNote RIS

Electronic Document Format (Vancouver)

Landsteiner I, Pinheiro JA, Felix N, Gewehr DM, Cardoso R. Chronic Anticoagulation in Patients with Atrial Fibrillation and COVID-19: A Systematic Review and Meta-Analysis. Arquivos Brasileiros de Cardiologia 2024;121(3):e20230470.

Electronic Document Format (ABNT)

Landsteiner, Isabela; Pinheiro, Jonathan A.; Felix, Nicole; Gewehr, Douglas Mesadri; Cardoso, Rhanderson. Chronic Anticoagulation in Patients with Atrial Fibrillation and COVID-19: A Systematic Review and Meta-Analysis. Arquivos Brasileiros de Cardiologia, v. 121, n. 3, e20230470, Apr. 2024.

Electronic Document Format (APA)

Landsteiner, I., Pinheiro, J. A., Felix, N., Gewehr, D. M., & Cardoso, R. (2024). Chronic Anticoagulation in Patients with Atrial Fibrillation and COVID-19: A Systematic Review and Meta-Analysis. Arquivos Brasileiros de Cardiologia, 121(3), e20230470.

Electronic Document Format (ISO)

Landsteiner, Isabela and Pinheiro, Jonathan A. and Felix, Nicole and Gewehr, Douglas Mesadri and Cardoso, Rhanderson. Chronic Anticoagulation in Patients with Atrial Fibrillation and COVID-19: A Systematic Review and Meta-Analysis. Arquivos Brasileiros de Cardiologia [online]. 2024, vol. 121, n. 3, [cited 2026-10-14], e20230470. Available from: <https://journals.cardiol.br/en/article/chronic-anticoagulation-in-patients-with-atrial-fibrillation-and-covid-19-a-systematic-review-and-meta-analysis/>. ISSN 0066-782X

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