Anticoagulants – ABC CARDIOL

IJCS

Editorial

Literacy in Cardiovascular Health: A Strategic Tool in Anticoagulation

Dalton Bertolim Precoma

Oral anticoagulation (OAC) with warfarin is still widely used in various clinical situations, such as in metallic prostheses. However, managing warfarin presents well-known challenges, including its narrow therapeutic range, long half-life, frequent drug and food interactions, and genetic variations. Additionally, poor adherence to treatment and lack of awareness about atrial fibrillation (AF) and anticoagulation itself significantly contribute to unfavorable clinical outcomes. Even with the use of direct oral anticoagulants (DOACs), there are still peculiarities among the different therapeutic options, which are often poorly communicated to the patient. This compromises the necessary understanding for effective disease management and highlights gaps in patient knowledge.

Social determinants of health play a fundamental role in individuals’ health conditions. Factors such as race/ethnicity, socioeconomic status, education level, environment, and climate, among others, have a direct impact on the incidence and management of chronic diseases, such as AF. Several studies indicate that people in situations of socioeconomic vulnerability — including low income, low education levels, and unemployment — show a higher prevalence of AF.^–

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Original Article

Association Between Functional Health Literacy and the Quality of Oral Anticogulation

Gustavo Chaves de Souza et al. Josiane Moreira da Costa Mayara Cristina Oliveira Ortiz Philipe Dias de Avila Lima … Pollyanna Evelyn de Freitas Nogueira Carla Jorge Machado Maria Auxiliadora Parreiras Martins

Abstract

Background:

Low functional health literacy in anticoagulated patients using warfarin has been widely discussed in medical literature.

Objective:

To identify the quality of oral anticoagulation (QOA) over time and to analyze the association between this variable and functional health literacy.

Methods:

Prospective cohort study conducted at an anticoagulation clinic (AC) in Minas Gerais, in a high-complexity hospital. The study included 81 patients, whose data were collected by direct consultation of medical records or by asking questions while patients were waiting for care. The QOA was assessed at 6, 9, 12, 15, and 18 months after the beginning of this study, and analyses of the association between this variable and functional health literacy were performed at the different time points. The QOA was identified by calculating the Therapeutic Time Range (TTR), with good quality being obtained with TTR values >59%. The incidence analysis of the TTR was performed for each of the five time points of the study through univariate Poisson regression. The significance level adopted in the statistical analysis was 5%.

Results:

Throughout the study, inadequate control of oral anticoagulation was observed, with only 20% of the patients showing persistent improvement in TTR values. No statistically significant association was identified at the different measurement times between TTR and functional health literacy.

Conclusion:

There was no direct association between the QOA and functional health literacy. However, the low incidence of persistent quality of anticoagulation in patients with low literacy suggests the development of specific educational actions for this subgroup of patients.

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Editorial

Factors Associated with Variation in Time in Therapeutic Range (TTR)

Felipe Costa de Souza

Anticoagulant therapy is recommended for several conditions, including atrial fibrillation (AF), venous thromboembolism, and after heart valve replacement. While warfarin is commonly used to prevent ischemic stroke in patients with AF, direct oral anticoagulants (DOACs) and nonpharmacologic therapies may be equally or more effective than traditional warfarin.^, In addition, warfarin has a narrow therapeutic index and can interact with many drugs and foods, which poses a challenge to using it.

A key strategy for reducing the risk of stroke or bleeding associated with warfarin is to maintain an optimal time in therapeutic range (TTR). TTR refers to the length of time a patient’s international normalized ratio (INR) remains between 2 and 3, which is a widely accepted measure of effective warfarin management. While there is no universally accepted safe range for TTR, patients whose INR is in the therapeutic range more than 70% of the time have better outcomes in terms of stroke prevention. In addition, those with INR control greater than 40% of the time have improved survival.

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Original Article

Factors Associated with Variation in Time in Therapeutic Range in Two Anticoagulation Clinics in Brazil

Josiane Moreira da Costa et al. Milena S. Marcolino Carla Jorge Machado Leandro Pinheiro Cintra … Izabella Fernanda Bastos Siqueira Daniel Dias Ribeiro Maria Auxiliadora Parreiras Martins

Abstract

Background

Time in therapeutic range (TTR) plays an important role in the effectiveness of anticoagulant therapy with vitamin K antagonists.

Objective

To identify factors associated with variation in TTR.

Methods

The study sites were anticoagulation clinics at two university hospitals in Minas Gerais, with a total of 1357 patients studied. TTR was calculated using the Rosendaal method. Binary logistic regressions were carried out with the study variables, followed by multiple regression with those that were significant for the model, adopting a significance level of 5%.

Results

The outpatient clinics presented different values in mean TTR; one corresponded to the expected percentage, while the other did not. Multiple regression identified the variable male sex as a protective factor in relation to TTR < 60% (odds ratio [OR]: 0.42; p = 0).

Conclusion

The identification of variables associated with inadequate TTR contributes to identifying weaknesses in the care process and implementing improvement actions in the hospitals studied.

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Original Article

Health Literacy, Patient Knowledge and Adherence to Oral Anticoagulation in Primary Care

Milena Soriano Marcolino et al. Thaís Lorenna Souza Sales João Antônio de Oliveira Danyelle Romana Alves Rios … Thaís Marques Pedroso Laura Caetano de Sá Maria Auxiliadora Martins Antonio Luiz Pinho Ribeiro

Abstract

Background

Warfarin is the only oral anticoagulant available in the Brazilian public health system. Health knowledge and treatment are essential to achieving the desirable therapeutic effect. However, data on these aspects among primary care patients are still lacking.

Objective

To assess health literacy, patient knowledge, and adherence to oral anticoagulation with warfarin, as well as the medication regimen complexity in primary health units in the municipality of Divinópolis, Minas Gerais, Brazil.

Methods

This cross-sectional study included patients using warfarin from primary care settings. Sociodemographic and clinical data were collected from medical records. Short Assessment of Health Literacy for Portuguese-Speaking Adults (SAHLPA-18), Oral Anticoagulation Knowledge (OAK), adaptation of the Measure of Adherence to Treatment (MAT-adapted) to oral anticoagulation, and Medication Regimen Complexity Index (MRCI) were applied, and the time in therapeutic range (TTR) was calculated. Patients were stratified in two groups (TTR < 60% and TTR ≥ 60%) and compared using Fisher's exact test at a significance level of p < 0.050.

Results

Analysis included 162 patients (64.8 ± 12.7 years old, 55.6% women). Nonvalvular atrial fibrillation (26.5%) and venous thromboembolism (24.1%) were the main indications for warfarin, and 67.9%, 88.3%, and 16.7% of the patients had inadequate health literacy, insufficient knowledge regarding anticoagulant therapy, and non-adherence to warfarin therapy, respectively. There was no significant association of these parameters in relation to TTR. MRCI showed high pharmacotherapy complexity between the drug prescriptions.

Conclusion

This study showed alarming insufficient knowledge about warfarin therapy and low health literacy in primary care patients.

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Original Article

Adherence and Quality of Life in Non-Valvular Atrial Fibrillation With Direct Oral Anticoagulants Versus Vitamin K Antagonists: A Systematic Review

Vanelise Zortea et al. Karine Duarte Curvello Diogo Pilger Antonios Douros … Lisiane Freitas Leal Tatiana da Silva Sempé Tatiane da Silva Dal Pizzol

Abstract

Background

Direct anticoagulants (DOACs) and vitamin K antagonists (VKAs) differ in pharmacokinetic characteristics, intensity of required laboratory monitoring, and costs. These differences could affect patients’ adherence to treatment and quality of life (QoL).

Objective

To assess whether patients with non-valvular atrial fibrillation (AF) using DOACs have better treatment adherence and QoL when compared to patients using VKAs.

Methods

We conducted a systematic review in Medline, Embase, LILACS, SciELO, CINAHL, and Cochrane Central, until June 9, 2021. We included studies that estimated and compared treatment adherence and QoL between DOACs and VKAs in adults with non-valvular AF. The methodological quality of the studies was assessed using the Joanna Briggs Institute (JBI) tools. The protocol was registered in the PROSPERO (CRD 42020165238).

Results

Sixteen studies, including 122,458 patients with non-valvular AF, evaluated adherence, and eleven studies, including 5,687 patients, assessed QoL. A variety of methods was used to measure adherence. Eleven studies showed no difference in adherence between DOACs and VKAs, while three studies favored VKAs over DOACs and two studies favored DOACs over VKAs. QoL was measured by specific (n = 3) or generic questionnaires (n = 8); results favored DOACs over VKAs in four studies, while in the other seven studies the results showed no difference between the groups. Meta-analyses were not performed due to high methodological heterogeneity among studies.

Conclusions

Available evidence regarding treatment adherence and QoL with DOACs and VKAs is characterized by methodological heterogeneity and conflicting findings.

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Original Article

Is Age Associated with Complications of Atrial Fibrillation Catheter Ablation?

Carlos Volponi Lovatto et al. Vinicius Louback Baldon Júlia Henriques Fabrício Vassallo … Eduardo Serpa Aloyr Simões Hermes Carloni Christiano Lemos Cunha Dalbian Gasparini Roberto Barbosa Osmar Araujo Calil Renato Giestas Serpa Luiz Fernando Machado Barbosa

Abstract

Background

Atrial fibrillation (AF) is the most frequent arrhythmia, and its prevalence increases with age. The management of AF in the elderly is challenging, as it is normally associated with comorbidities and frailty. AF catheter ablation (CA) is a safe and superior alternative to antiarrhythmic drugs (AADs) for the maintenance of sinus rhythm.

Objectives

To evaluate the rate of complications associated with CA for AF across different age groups.

Methods

A retrospective analysis of 219 patients who underwent CA for AF between 2016 and 2020 were divided into 3 age groups: less than 60 years, 60 to 70 years, and > 70 years. All the included patients underwent radiofrequency ablation using an electroanatomic mapping system. Categorical variables were evaluated with chi-square and Fisher’s test, and continuous variables were evaluated by Kruskal-Wallis and post-hoc Tamhane’s T2. P values less than 0.05 were considered significant.

Results

We found an overall total complication rate of 4.6%. The total complication rate was 3.3% in patients 70 years (p = 0.742). No deaths occurred.

Conclusion

There was no significant difference in the AF CA-related complications when comparing the patients by age group.

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Editorial

Atrial Fibrillation and Hemodialysis – Should we Anticoagulate These Patients? Ischemic Versus Hemorrhagic Risk

Iara Atié Malan

Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide, and it is a very frequent cause of increased morbidity and mortality in adults. This arrhythmia favors the formation of thrombi, which can lead to systemic embolism, such as ischemic stroke.

To identify patients with thromboembolic risk, the most used score is the CHA2DS2VASC, which takes the following factors in consideration: heart failure, arterial hypertension, age, diabetes, previous stroke, vascular disease, and sex. It is worth emphasizing that this score does not take renal function or dialysis treatment into consideration.

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Editorial

Rivaroxaban: is it Really Need to Monitor its Anticoagulant Effect in Clinical Practice?

Luiz Eduardo Montenegro Camanho et al. Gustavo Vignoli dos Santos

Oral anticoagulation (OAC) has been the cornerstone for the treatment of atrial fibrillation (AF) patients. The vitamin K antagonist warfarin has been considered the drug of choice in stroke prevention with proven efficacy for more than 60 years. The great inter-patient and intra-patient dose variability and need for routine International Normalized Ratio (INR), are among the main disadvantages of warfarin. The direct-acting oral anticoagulants (DOACs), including direct thrombin inhibitors (dabigatran) and factors Xa inhibitors (apixaban, edoxaban, and rivaroxaban), are currently the therapy of choice for preventing thromboembolic events in patients with atrial fibrillation. Unlike warfarin and other vitamin K antagonists, the DOACs are administered in fixed doses and do not require routine laboratory monitoring.

Rivaroxaban is an oral inhibitor of free and clot-associated factor Xa through reversible, competitive interactions with its active site. Bioavailability following oral administration is dose-dependent, and it is highly bound to plasma proteins. Plasma levels peak 2 to 4 h following oral administration, partially excreted by the kidneys, and has a half-life depending on the dose and age. Factor Xa inhibitors variably affect prothrombin time (PT), with concentration-dependent PT prolongation. The sensitivity of the different assays varies widely, depending on the thromboplastin reagent, and it is recommended to check the sensitivity of PT in each institution. At therapeutic doses, rivaroxaban has a relatively weak effect on PT, but there is a more pronounced effect on supratherapeutic doses.

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Case Report

Pulmonary Embolism in Patients with Covid-19 in Direct Oral Anticoagulant

Fabio Augusto De Luca et al. Guilherme Arruda Vinicius Esteves André Feldman … Ítalo Bruno dos Santos Sousa José Célio Vieira Brandão Raquel Muarrek Garcia Olga Ferreira de Souza

Introduction

The global pandemic caused by the new coronavirus (COVID-19) has been promoting major challenges and unprecedented clinical decisions in the medical scenario. Currently, according to the World Health Organization, the disease affects over 185 countries, with over 12 million people infected and nearly 500 thousand deaths.

Among the most serious manifestations of the syndrome, the high prevalence of thromboembolic events, up to 31% of the patients hospitalized in intensive care units, according to an international series, calls attention.^– Different mechanisms of action related to the infection by SARS-CoV-2 may be related to thrombosis: excessive inflammation, tissue hypoxia, immobilization, and disseminated intravascular coagulation (DIC); however, one question remains: Is the etiology linked to some specific effect of the virus or a reflex of the severity of the case? Despite the anticoagulant therapy emerging as a major weapon in the therapeutic arsenal, data is still scarce in the literature regarding the efficacy and safety of warfarin or direct oral anticoagulants (DOAC) in this specific setting. It should be highlighted that, of the 1.5 million people currently infected in Brazil, a significant number present a history of cardiovascular disease and are presently taking anticoagulants. This class of drugs may show serious interactions with investigational therapies currently employed for COVID-19, which could increase the risk of thrombotic or hemorrhagic events. In this context, it becomes imperative to highlight that the thrombosis associated with COVID-19 and anticoagulant therapy is a unique scenario and must be investigated.

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Original Article

Atrial Fibrillation and Use of Rivaroxaban: Performance of the Prothrombin Time / INR as a Function of Time After Blood Collection

Rita Carolina Figueiredo Duarte et al. Priscila Samara Sérgio Moreira Cláudia Natália Ferreira Estevão Lanna Figueiredo … Eduardo Sternick Francisco Rezende Silveira Luan Carlos Vieira Alves Ana Paula Lucas Mota Edna Afonso Reis Maria das Graças Carvalho Helton José dos Reis

Abstract

Background

Traditionally, the most effective therapy in the prevention of stroke in patients with atrial fibrillation (AF) has been oral anticoagulation with vitamin K inhibitors, particularly warfarin, whose disadvantages and adverse effects have led to their replacement by “direct oral anticoagulants”, as factor X inhibitor.

Objectives

This study aimed to conduct a brief approach on atrial fibrillation (AF) and use of Rivaroxaban, and to comparatively evaluate the prothrombin time / International Normalized Ratio (PT/INR) in patients with AF in use of this oral anticoagulant, depending on the time elapsed between the last administration of the drug and the time of blood sample venipuncture.

Methods

We evaluated 34 patients with AF in use of Rivaroxaban by using PT / INR, distributed into a subgroup with blood collection time ≤ 12 hours (n = 7) and > 12 hours after the last drug intake (n = 27). Mann-Whitney test was used to compare the groups and p < 0.05 was considered significant.

Results

An analysis as a function of time between the Rivaroxaban intake and blood collection, revealed that PT / INR suffers the greatest effect up to 12 hours after ingestion of the drug, dropping to levels close to normal in subsequent hours before the next dose.

Conclusion

We concluded that, in contrast to warfarin, the knowledge of the time interval between drug intake and blood collection from patients taking Rivaroxaban is essential to properly interpret a laboratory test to assess hemostasis, particularly PT and its derivatives. Int J Cardiovasc Sci. 2020; [online].ahead print, PP.0-0

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Viewpoint

Challenges in Pharmacological Management of Cardiovascular Diseases in Covid-19: do Benefits Outweigh Risks?

Samuel de Sousa Pedro et al. Fernanda Carla Ferreira de Brito Christianne Bretas Vieira Scaramello

Introduction

Cardiovascular diseases (CVD) are the main cause not only of global mortality but also of reduced quality of life. They cover ischemic heart disease, stroke, heart failure, peripheral artery disease, and various other heart and vascular conditions. In 2017, CVDs caused about 17.8 million deaths worldwide, corresponding to 330 million years of life lost and another 35.6 million years of life with disabilities. Almost 80% of deaths occur in low- and middle-income countries, such as Brazil, where the occurrence of CVDs and their risk factors are on the rise as a result of an ongoing epidemiological transition. In low-income countries CVDs greatly affect working-age populations, and the total economic loss resulting from this group of diseases is high, representing 2% of Gross Domestic Product. In addition, the disability caused by CVDs has economic consequences at multiple levels: individual, family, economic agents, public institutions, government, and society as a whole.

Recent studies also show that chronic conditions, such as CVD, increase the risk of aggravation and death associated with the new coronavirus 2019 disease (COVID-19), whose outbreak was characterized as a pandemic by the World Health Organization (WHO) in March 2020. The new coronavirus is a betacoronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus 2), phylogenetically identical to other coronaviruses capable of determining acute respiratory distress syndrome (ARDS), which is responsible for numerous deaths. The most common symptoms of COVID-19 include fever, cough, dyspnea, myalgia, fatigue, diarrhea, sore throat, chest pain, confusion, and lethargy. Acute and chronic cardiovascular complications have also been observed in the course of COVID-19, being attributed to several mechanisms, such as relative ischemia, systemic inflammation mediated by pathogens, with increased levels of several biomarkers. In this context, studies point to the relevance not only of chronic conditions, such as hypertension, but also of the age and immunological status of the host, characterizing a complex, multifactorial, and bidirectional model that can comprehend the drugs used to treat these pathologies.

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Editorial

Challenges for Anticoagulation in Atrial Fibrillation

Ana Inês da Costa Bronchtein

Atrial fibrillation (AF) is the most prevalent arrhythmia in the world. It is considered a current epidemic and one of the main causes of ischemic stroke, usually with severe and debilitating conditions, and is responsible for systemic cardioembolic phenomena, increased number of cases of congestive heart failure (CHF), cognitive impairment related to silent embolic phenomena, and increased overall mortality in affected patients.

Vitamin K antagonists (VKA) represented in the vast majority of studies with warfarin have been widely used for many years; however, they have complex adherence due to several factors, including the need for frequent INR monitoring, regular dose adjustments for maintaining a suitable time in therapeutic range (TTR) (>= 70%) and interactions with a number of drugs and foods, which contributed to its ever decreasing use. Direct-acting anticoagulants (DACs), represented by dabigatran, rivaroxaban, apixaban and, more recently, edoxaban, offer an alternative to VKA, without the disadvantages presented by the latter.

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Original Article

Trends and Predictors of Oral Anticoagulation in Patients with Atrial Fibrillation: A Serial Cross-Sectional Study from 2011 to 2016

Maria de Fátima de Araújo Geraldes et al. Eduardo Sahade Darze Paulo Novis Rocha

Abstract

Background:

Despite the efficacy of vitamin K antagonists against stroke in patients with atrial fibrillation (AF), the underuse of this therapy is well documented.

Objectives:

To evaluate trends and predictors of oral anticoagulants utilization in patients with AF.

Methods:

Observational, retrospective, serial cross-sectional study between 2011-2016. Comparisons between groups were performed using the Student t, Mann-Whitney and Chi-square tests. Logistic regression was used to identify independent predictors of anticoagulation. A p value < 0.05 was considered significant.

Results:

A total of 377 patients were analyzed. The mean age was 70 ± 15 years; 52% were male and 75% were anticoagulated (20% with VKA and 55% with DOAC). Over 5 years, the overall frequency of anticoagulation increased by 22.4%. The use of DOACs increased from 29% to 70%, whereas the use of VKA decreased from 36% to 17%. The use of antiplatelet agents alone also fell from 21% to 6%. The predictors of anticoagulation were previous episodes of AF (OR 3.1, p < 0.001), hypertension (OR 3.0, p < 0.001) and HASBLED score (OR 0.5, p < 0.001). The predictors of DOAC use were serum creatinine (OR 0.2, p = 0.002), left atrial size (OR 0.9, p = 0.003) and biological valve prosthesis (OR 0.1, p = 0.007). Of the 208 patients using DOACs, 63 (30%) received inadequate prescriptions: 5 with severe drug interactions and 58 with incorrect dosing.

Conclusions:

Between 2011 and 2016, DOACs were rapidly incorporated into clinical practice, replacing AVKs and antiplatelets, and contributing to greater use of anticoagulation in patients with AF.

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Original Article

SAMe-TT2R2 Score: A Useful Tool in Oral Anticoagulation Decision-Making for Venous Thromboembolism Patients?

Fernando Pivatto Júnior et al. Rafaela Fenalti Salla Lísia Cunha Cé Andréia Biolo … André Luís Ferreira Azeredo da Silva Bruno Führ Luís Carlos Amon Marina Bergamini Blaya Rafael Selbach Scheffel

Abstract

Background:

The SAMe-TT₂R₂ score was introduced to identify atrial fibrillation patients with a high risk of not achieving a good time in therapeutic range (TTR) during vitamin K antagonists (VKA) therapy.

Objective:

The aim of this study was to evaluate this score in venous thromboembolism (VTE) patients.

Patients and methods:

A retrospective cohort study of patients receiving care at the outpatient anticoagulation clinic of a tertiary care teaching hospital. Patients were classified as having low (score 0-1) or high risk (score ≥ 2) of not achieving a good TTR. The area under the ROC curve was calculated to assess the ability of the score to predict a TTR ≥ 65%. Adverse event-free survival curves according to the SAMe-TT₂R₂ score were calculated by the Kaplan-Meier method and compared by the log-rank test. A p-value < 0.05 was considered statistically significant.

Results:

We investigated 111 patients during a median follow-up of 2.3 (0.7-6.4) years. Mean age was 54.1 ± 15.7 years and 71 (64.0%) were women. Low- and high-risk groups had similar mean TTR (51.9 vs. 49.6%; p = 0.593). The two groups did not differ significantly in the percentage of patients achieving a TTR ≥ 65% (35.6 vs. 25.8%; p = 0.370). The c-statistic was 0.595 (p = 0.113) for TTR ≥ 65%. Adverse event-free survival during anticoagulation was also similar in both groups (p = 0.136).

Conclusions:

The SAMe-TT₂R₂ score does not seem to be a useful tool in oral anticoagulation decision-making for patients with VTE and should not be used in this setting.

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