Anticoagulants / therapeutic use

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Editorial

Anticoagulation Therapy with Warfarin: A Reality of Brazilian Public Health that Lacks Structure for Better Control

The increase in longevity in recent decades has led to a progressive increase in the prevalence of atrial fibrillation (AF) worldwide.^,

As a result, anticoagulation therapy has become increasingly indicated in preventing thromboembolic events. The need for continuous use drove the preference for oral anticoagulants, historically represented by antivitamin K (VKA) drugs and, more recently, by new anticoagulants (anti-factor X). Among these, a VKA, warfarin, is the most prominent for its low cost.

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Editorial

Tackling Bleeding – One Appendage at a Time

Stefano Garzon et al. Willterson Carlos Bandeira

Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting approximately 80% of the population aged 80 years or older. It increases the risk of cardioembolic stroke 5-fold across all ages and is related to more than 20% of strokes in patients above 80 years. Embolic strokes are often more severe than other strokes, and anticoagulants are the cornerstone of the treatment, paramount to reducing cardioembolic risk in this population. However, the decision to start oral anticoagulants is not always straightforward and requires assessing both embolic and bleeding risks. Embolic risk in patients with AF is usually assessed using standardized scoring systems such as the CHA₂DS₂-VASc score, but it can be further refined using other clinical data such as left atrial size and duration of AF. Bleeding risk is usually assessed using the HAS-BLED score, with severe bleedings being more common in older patients. For that reason, physicians are often fearful of starting anticoagulation in older patients, even though current evidence shows that it is usually safe to use oral anticoagulants in most of these patients. However, major bleeding can occur in up to 3% of patients using oral anticoagulants, requiring the interruption of the treatment.

Over 90% of all left atrial thrombi originate in the LAA, and the risk reduction with LAA occlusion is comparable to anticoagulation. For this reason, percutaneous LAA occlusion has emerged as an alternative treatment for patients with either contra-indications to oral anticoagulation or an embolic event while using oral anticoagulants. There is growing evidence that LAA occlusion is safe and feasible in most patients,^– and this initial multi-centric experience of LAA occlusion using the plug-based device LAmbre in Brazil shows similar results to current medical literature. In this study, 74.6% of all patients have had either a major bleeding episode using oral anticoagulants or a stroke despite oral anticoagulation. Patients were at high embolic and bleeding risks, with a mean CHA₂DS₂-VASc score of 4.6 ± 1.7 and a mean HAS-BLED score of 3.4 ± 1.1. The procedure’s success rate was 100%, with no deaths or strokes at a mean follow-up of 18 ± 12 months.

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Editorial

Thrombolysis in Pulmonary Embolism: Octagenarians Deserve More Attention!

Hugo Hyung Bok Yoo

Pulmonary embolism (PE) is a common cardiovascular disease that may be life threatening, and its incidence increases with age. It is the third most common cause of cardiovascular mortality and is also responsible for 100,000 to 180,000 deaths per year. Right-sided heart failure and recurrences are the main causes of death associated with PE. Most deaths occur within the first hour of patients presenting hemodynamic instability. Therefore, the prognostic of those patients depends on rapid treatment.^,

To determine a suitable therapeutic management approach in patients with PE, the appropriate risk stratification is decisive in order to begin effective treatment as early as possible and to prevent death. Thus, patients at a low-risk of mortality may be candidates for home anticoagulant treatment or early hospital discharge. Patients at intermediate risk may require antithrombotic therapy and close clinical observation to escalate the treatment regime in case of clinical impairment, whereas patients at high-risk should proceed to prompt revascularization either by pharmacologic or percutaneous catheter-directed or surgical treatment.

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Viewpoint

COVID-19 and Hypercoagulable State: A New Therapeutic Perspective

Jorge Henrique Paiter Nascimento et al. Bruno Ferraz de Oliveira Gomes Plínio Resende do Carmo Júnior João Luiz Fernandes Petriz … Stephanie Itala Rizk Isabela Bispo Santos da Silva Costa Marcus Vinicius Guimarães Lacerda Fernando Bacal Ludhmila Abrahão Hajjar Gláucia Maria Moraes de Oliveira

The novel coronavirus, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is responsible for the outbreak of the viral pneumonia identified for the first time in the Chinese city of Wuhan at the end of 2019. The outbreak has expanded rapidly, affecting 184 countries. The experience acquired in past months identified different clinical presentations with varied severity, ranging from asymptomatic infection to death due to multiple organic dysfunction. The World Health Organization (WHO) has recently defined the complex process of the SARS-CoV-2 infection as novel coronavirus disease 2019 (COVID-19).

COVID-19, whose notification grows fast in different countries, currently affects more than one million people worldwide according to the WHO, which has characterized the infection as a pandemic. As of April 29, 2020, Brazil had registered 73,235 confirmed cases of COVID-19 and 5,083 deaths, with a case-fatality rate of 6,9%. Hospitalization is necessary in up to 20% of the patients infected by SARS-CoV-2, and 5% to 10% of them require admission to the intensive care unit because of the need for hemodynamic and/or ventilatory support.^– The mortality rate ranges from 0.8% to 12% depending on the country, and this difference might result from multiple factors, of which the healthcare system structure stands out.^– Patients with the moderate and severe forms of the disease had manifestations mainly of the respiratory system involvement, with clinical findings ranging from mild pneumonia to acute respiratory distress syndrome (ARDS).^,-

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Viewpoint

Internet Search Trends and Regional Mortality Tendencies: The Case of Oral Anticoagulants and Stroke

Roberto Muniz Ferreira et al. Ísis da Capela Pinheiro João Roquette Fleury da Rocha

Introduction

Multiple studies have found that up to 30% of ischemic strokes are associated with atrial fibrillation (AF), especially in the elderly population.^, Although the embolic risk varies according to clinical characteristics and comorbidities, anticoagulant therapy has consistently shown to reduce stroke rates by approximately 70%. However, previous studies demonstrated that treatment rates with warfarin were low, even in patients at high risk for embolic events. Despite evidence from various publications demonstrating the effectiveness and safety of vitamin K antagonists, their complex pharmacokinetics and the need for continuous monitoring and frequent dose adjustments were the main explanations for low adherence.

Over the last 10 years, four direct oral anticoagulants (DOAC) have become available to prevent embolic events in patients with non-valvular AF: dabigatran, rivaroxaban, apixaban and edoxaban. In August 2011, dabigatran was the first DOAC approved in Brazil for stroke prevention, followed by rivaroxaban four months later. Two years later, apixaban was also introduced in the Brazilian market and only in February 2018 edoxaban became available. When compared to warfarin, multiple trials have suggested that DOACs are non-inferior in preventing ischemic strokes and possibly superior in reducing mortality, perhaps due to fewer intracranial hemorrhages. In addition to waive the need for laboratory monitoring, they have more predictable pharmacokinetics and a lower incidence of drug-to-drug interactions. Recent studies have demonstrated an increase in anticoagulation prescription rates among physicians since DOACs have become clinically available.

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Original Article

Safety of Catheter Ablation of Atrial Fibrillation Under Uninterrupted Rivaroxaban Use

Márcio Augusto Silva et al. Guilherme Muller de Campos Futuro Erick Sessa Merçon Deborah Vasconcelos … Rovana Silva Agrizzi Jorge Elias Neto Ricardo Kuniyoshi

Abstract

Background:

Atrial fibrillation (AF) ablation under uninterrupted warfarin use is safe and recommended by experts. However, there is some controversy regarding direct-acting oral anticoagulants for the same purpose.

Objective:

To evaluate the safety of AF ablation under uninterrupted anticoagulation with rivaroxaban.

Methods:

A series of 130 patients underwent AF radiofrequency ablation under uninterrupted rivaroxaban use (RIV group) and was compared to a control group of 110 patients under uninterrupted warfarin use (WFR group) and therapeutic International Normalized Ratio (INR). We analyzed death, rates of thromboembolic events, major and minor bleedings, activated clotting time (ACT) levels, and heparin dose in the procedure. The ablation protocol basically consisted of circumferential isolation of the pulmonary veins guided by electroanatomic mapping. It was adopted a statistical significance of 5%.

Results:

The clinical characteristics of the groups were similar, and the paroxysmal AF was the most frequent type (63% and 59%, RIV and WFR groups). A thromboembolic event occurred in the RIV group. There were 3 patients with major bleeding (RIV = 1 and WFR = 2; p = 0.5); no deaths. Basal INR was higher in the WFR group (2.5 vs. 1.2 ± 0.02; p < 0.0001), with similar basal ACT levels (123.7 ± 3 vs. 118 ± 4; p= 0, 34). A higher dose of venous heparin was used in the RIV group (9,414 ± 199 vs. 6,019 ± 185 IU; p < 0.0001) to maintain similar mean ACT levels during the procedure (350 ± 3 vs. 348.9 ± 4; p = 0.79).

Conclusion:

In the study population, AF ablation under uninterrupted rivaroxaban showed a safety profile that was equivalent to uninterrupted warfarin use with therapeutic INR.

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Original Article

Left Atrial Appendage Transcatheter Occlusion with AMPLATZER™ Amulet™ Device: Real Life Data with Mid-Term Follow-Up Results

Mehmet Levent Şahiner et al. Ergun Baris Kaya Cem Çöteli Kudret Aytemir

Abstract

Background:

Left atrial appendage (LAA) occlusion is an alternative therapy for atrial fibrillation patients who have high embolic risk and contraindications to anticoagulant therapy.

Objective:

To evaluate the feasibility, safety, and mid-term outcomes of percutaneous LAA occlusion, including device-related thrombosis.

Methods:

Sixty consecutive patients who had undergone percutaneous LAA occlusion with AMPLATZER™ Amulet™ device from September 2015 to March 2018 were enrolled. Patients were followed for 21 ± 15 months (median – 20 months, interquartile range – 9 to 27 months). The postprocedural assessment was done at the 1^(st), 6^(th), and 12^(th) month. Patients were clinically evaluated, and transesophageal echocardiography was performed at each visit. We evaluated the condition of normality of variables using the Kolmogorov-Smirnov test. P-values < 0.05 were statistically significant.

Results:

The most common indication for the procedure was major bleeding with anticoagulants (n: 53, 88.3%). The procedure was completed successfully in 59 (98.3%) patients. Periprocedural mortality was observed in one patient. Postprocedural antiplatelet treatment was planned as dual or single antiplatelet therapy or low-dose anticoagulant therapy in 52 (88.1%), 2 (3.4%), and 5 (8.5%) patients, respectively. We found no clinically significant cerebrovascular events, device-related thrombus, or embolization in any patient during the follow-up. Two (3.4 %) patients presented significant peri-device leak (>3 mm) at the 1^st month evaluation, which disappeared at the 12^th month follow-up.

Conclusion:

We concluded that LAA occlusion using the Amulet™ LAA occluder can be performed with high procedural success and acceptable outcomes.

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Original Article

Oral Anticoagulation in Atrial Fibrillation: Development and Evaluation of a Mobile Health Application to Support Shared Decision-Making

Laura Siga Stephan et al. Eduardo Dytz Almeida Raphael Boesche Guimarães Antonio Gaudie Ley … Rodrigo Gonçalves Mathias Maria Valéria Assis Tiago Luiz Luz Leiria

Abstract

Background:

Atrial fibrillation is responsible for one in four strokes, which may be prevented by oral anticoagulation, an underused therapy around the world. Considering the challenges imposed by this sort of treatment, mobile health support for shared decision-making may improve patients’ knowledge and optimize the decisional process.

Objective:

To develop and evaluate a mobile application to support shared decision about thromboembolic prophylaxis in atrial fibrillation.

Methods:

We developed an application to be used during the clinical visit, including a video about atrial fibrillation, risk calculators, explanatory graphics and information on the drugs available for treatment. In the pilot phase, 30 patients interacted with the application, which was evaluated qualitatively and by a disease knowledge questionnaire and a decisional conflict scale.

Results:

The number of correct answers in the questionnaire about the disease was significantly higher after the interaction with the application (from 4.7 ± 1.8 to 7.2 ± 1.0, p < 0.001). The decisional conflict scale, administered after selecting the therapy with the app support, resulted in an average of 11 ± 16/100 points, indicating a low decisional conflict.

Conclusions:

The use of a mobile application during medical visits on anticoagulation in atrial fibrillation improves disease knowledge, enabling a shared decision with low decisional conflict. Further studies are needed to confirm if this finding can be translated into clinical benefit.

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Original Article

Fondaparinux versus Enoxaparin – Which is the Best Anticoagulant for Acute Coronary Syndrome? – Brazilian Registry Data

Alexandre de Matos Soeiro et al. Pedro Gabriel Melo de Barros e Silva Eduardo Alberto de Castro Roque Aline Siqueira Bossa … Maria Cristina César Sheila Aparecida Simões Mariana Yumi Okada Tatiana de Carvalho Andreucci Torres Leal Fátima Cristina Monteiro Pedroti Múcio Tavares de Oliveira Jr.

Abstract

Background:

Recent studies have shown fondaparinux’s superiority over enoxaparin in patients with non-ST elevation acute coronary syndrome (ACS), especially in relation to bleeding reduction. The description of this finding in a Brazilian registry has not yet been documented.

Objective:

To compare fondaparinux versus enoxaparin in in-hospital prognosis of non-ST elevation ACS.

Methods:

Multicenter retrospective observational study. A total of 2,282 patients were included (335 in the fondaparinux group, and 1,947 in the enoxaparin group) between May 2010 and May 2015. Demographic, medication intake and chosen coronary treatment data were obtained. Primary outcome was mortality from all causes. Secondary outcome was combined events (cardiogenic shock, reinfarction, death, stroke and bleeding). Comparison between the groups were done through Chi-Square test and T test. Multivariate analysis was done through logistic regression, with significance values defined as p < 0.05.

Results:

With regards to treatment, we observed the performance of a percutaneous coronary intervention in 40.2% in the fondaparinux group, and in 35.1% in the enoxaparin group (p = 0.13). In the multivariate analysis, we observed significant differences between fondaparinux and enoxaparin groups in relation to combined events (13.8% vs. 22%. OR = 2.93, p = 0.007) and bleeding (2.3% vs. 5.2%, OR = 4.55, p = 0.037), respectively.

Conclusion:

Similarly to recently published data in international literature, fondaparinux proved superior to enoxaparin for the Brazilian population, with significant reduction of combined events and bleeding.

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Point of view

Patient Management with Metallic Valve Prosthesis during Pregnancy and Postpartum Period

Juliane Dantas Seabra Garcez et al. Vitor Emer Egypto Rosa Antonio Sergio de Santis Andrade Lopes Tarso Augusto Duenhas Accorsi … João Ricardo Cordeiro Fernandes Pablo Maria Pomerantzeff Walkiria Samuel Avila Flavio Tarasoutchi

Abstract

Prosthetic thrombosis is a rare complication, but it has high mortality and morbidity. Young women of childbearing age that have prosthetic heart valves are at increased risk of thrombosis during pregnancy due to changes in coagulation factors. Anticoagulation with adequate control and frequent follow-up if pregnancy occurs must be performed in order to prevent complications related to anticoagulant use. Surgery remains the treatment of choice for prosthetic heart valve thrombosis in most clinical conditions.

Patients with metallic prosthetic valves have an estimated 5% risk of thrombosis during pregnancy and maternal mortality of 1.5% related to the event. Anticoagulation with vitamin K antagonists during pregnancy is related to varying degrees of complications at each stage of the pregnancy and postpartum periods. Warfarin sodium crosses the placental barrier and when used in the first trimester of pregnancy is a teratogenic agent, causing 1-3% of malformations characterized by fetal warfarin syndrome and also constitutes a major cause of miscarriage in 10-30% of cases. In the third trimester and at delivery, the use of warfarin is associated with maternal and neonatal bleeding in approximately 5 to 15% of cases, respectively. On the other hand, inadequate anticoagulation, including the suspension of the oral anticoagulants aiming at fetal protection, carries a maternal risk of about 25% of metallic prosthesis thrombosis, particularly in the mitral valve. This fact is also due to the state of maternal hypercoagulability with activation of coagulation factors V, VI, VII, IX, X, platelet activity and fibrinogen synthesis, and decrease in protein S levels.

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