Successful use of rivaroxaban achieving therapeutic anti-factor xa levels in a morbidly obese patient with acute intermediate-high risk pulmonary embolism / Uso bem-sucedido de rivaroxabana com níveis terapêuticos de antifator xa em paciente com obesidade mórbida e embolia pulmonar aguda de risco intermediário-alto

Abstract Direct oral anticoagulants (DOACs) have become the standard of care for acute and long-term therapy for venous thromboembolism (VTE) due to their efficacy and safety profiles. The 2021 International Society on Thrombosis and Haemostasis guidelines recommend using standard DOAC dosages in patients with BMI >40 kg/m2 or weight >120 kg. Use of DOACs remains uncertain in morbidly obese patients with VTE, including acute PE. A morbidly obese woman in her 30s who presented with acute worsening of dyspnea was diagnosed with acute intermediate-high risk acute pulmonary embolism and concomitant proximal deep vein thrombosis, constituting a clinically challenging scenario for treating her with rivaroxaban. Standard doses of rivaroxaban for acute and extended phase treatment of venous thromboembolism in individuals with morbid obesity at BMI>70 kg/m2 may be effective, and safe.

Resumo Devido à sua eficácia e aos seus perfis de segurança, os anticoagulantes orais diretos (DOACs) tornaram-se o padrão de cuidado para a terapia aguda e de longo prazo de tromboembolismo venoso (TEV). As diretrizes da Sociedade Internacional de Trombose e Hemostasia de 2021 recomendam o uso de dosagens padrão de DOACs em pacientes com índice de massa corporal (IMC) > 40 kg/m2 ou peso > 120 kg. O uso de DOACs em pacientes com obesidade mórbida e TEV, incluindo embolia pulmonar aguda, ainda não foi esclarecido. Uma mulher com obesidade mórbida na faixa dos 30 anos que apresentou piora aguda da dispneia foi diagnosticada com embolia pulmonar aguda de risco intermediário-alto e trombose venosa profunda proximal concomitante, com o cenário clínico desafiador de tratá-la com rivaroxabana. Doses padrão de rivaroxabana para tratamento e recorrência de tromboembolismo venoso em indivíduos com obesidade mórbida e IMC > 70 kg/m2 podem ser eficazes e seguras.

Predictores de uso de anticoagulantes orales directos en tromboembolia pulmonar aguda / Predictors of use of direct oral anticoagulants in acute pulmonary embolism

Resumen Introducción: En la última década los anticoagulantes orales directos (ACOD) se incorporaron como herramienta para la anticoagulación en pacientes con tromboembolia pulmonar (TEP) aguda. Aunque tienen un mejor perfil farmacológico que los antagonistas de la vitamina K (AVK), el uso de estos fármacos no es masivo. El objetivo del presente trabajo fue evaluar el uso de ACOD en pacientes con TEP aguda y detectar determinantes de su indicación. Metodología: Análisis preespecificado del registro CONAREC XX que incorporó pacientes con TEP aguda en 64 centros de Argentina. Se realizó un análisis para detectar predictores de prescripción de ACOD al alta. Resultados: Se analizaron 579 pacientes que recibieron anticoagulación al alta hospitalaria: el 60% recibió AVK, el 21% heparinas y el 19% ACOD (de ellos, un 49% rivaroxabán, un 34% apixabán y un 17% dabigatrán). Los pacientes que recibieron ACOD tenían TEP de menor gravedad, menor riesgo de hemorragia y menos complicaciones intrahospitalarias. En el seguimiento a 30 días no hubo diferencias en mortalidad por todas las causas o sangrados. La cobertura de salud por un seguro social (odds ratio [OR] 7.45; intervalo de confianza del 95% [IC 95%]: 1.74-31.9; p < 0.01) o por cobertura privada (OR 10.5; IC 95%: 2.4-45.9; p < 0.01) fueron predictores independientes de la prescripción de ACOD al alta, y el antecedente de insuficiencia cardiaca (OR 0.19; IC 95%: 0.04-0.84; p = 0.028) y de enfermedad oncológica (OR 0.49; IC 95%: 0.27-0.89; p = 0.02) fueron predictores de no prescribirlos. Conclusiones: Uno de cada cinco supervivientes de TEP aguda recibió ACOD al egreso hospitalario en Argentina, y esto fue determinado por variables clínicas y económicas

Abstract Introduction: In the last decade, direct oral anticoagulants (DOACs) have been incorporated as an anticoagulation tool in patients with acute pulmonary thromboembolism (PTE). Although they have a better pharmacological profile than vitamin K antagonists (VKA), the use of these drugs is not massive. The objective of this study was to evaluate the use of DOACs in patients with acute PE and to detect determinants of its use. Methodology: Prespecified analysis of the CONAREC XX registry that included patients with acute PE in 64 centers in Argentina. An analysis was performed to detect predictors of DOAC prescription at discharge. Results: 579 patients who received anticoagulation at hospital discharge were analyzed: 60% received VKA, 21% heparin and 19% DOAC (of them, 49% Rivaroxaban, 34% Apixaban, and 17% Dabigatran). Patients receiving DOACs had less severe PE, lower risk of bleeding, and fewer in-hospital complications. At 30-day follow-up, there were no differences in all-cause mortality or bleeding. Health coverage by social insurance (OR 7.45, CI 95% 1.74-31.9, p < 0.01) or by private coverage (OR 10.5, CI 95% 2.4-45.9, p < 0.01) were independent predictors of DOAC prescription at discharge, and history of heart failure (OR 0.19, 95% CI 0.04-0.84, p = 0.028) and oncological disease (OR 0.49, 95% CI 0.27-0.89; p = 0.02) were predictors not prescribe them. Conclusions: One in five survivors of acute PE received DOACs at hospital discharge in Argentina, and this was determined by clinical and economic variables.

Recomendaciones de manejo de los anticoagulantes orales directos (DOACs) anti Xa y anti IIa / Recommendations for the practical management of the direct oral anticoagulants anti Xa and anti IIa

Resumen Los anticoagulantes orales directos han surgido como una de las herramientas que ha cambiado el manejo de la enfermedad trombótica en los últimos 15 años. Sus ventajas, desde el punto de vista de la facilidad de uso y menor riesgo de sangrado, especialmente de sangrado cerebral, han posicionado a estos nuevos anticoagulantes como la primera alternativa de tratamiento en las dos indicaciones más frecuentes en que necesitamos estas drogas, la fibrilación auricular y la enfermedad tromboembólica venosa. Sin embargo, no todos los pacientes pueden recibir estos agentes, no todos los anticoagulantes directos tienen las mismas pro piedades y fundamentalmente, no todas las enfermedades con indicación de un anticoagulante pueden tratarse con ellos;con lo cual es necesario que todos los profesionales que están involucrados en el manejo de estos medicamentos estén obligados a conocerlos en profundidad, para poder decidir el mejor tratamiento en cada caso particular. Este documento de posición de expertos de diferentes especialidades de Argentina, presenta lineamientos para el uso correcto de los anticoagulantes directos en base a nueva evidencia y a la experiencia de uso de un amplio grupo de profesionales. La forma de relacionarnos con el tratamiento anticoagulante ha cambiado. Los médicos que trabajamos con ellos también debemos hacerlo.

Abstract Direct oral anticoagulants have emerged as the drugs that have changed the man agement of the antithrombotic treatment in the last 15 years. Their advantages, like a more friendly way of anticoagulation and their lower risk of bleeding, especially in the brain, have positioned these new anticoagu lants as the first drug of choice in the two most frequent indications of anticoagulation, atrial fibrillation, and the venous thromboembolic disease. However, not all the patients can receive these agents, not all the direct oral anticoagulants have the same characteristics, and most importantly, not all the diseases with an indication of an anticoagulant drug can be treated with them. Therefore, it is mandatory that all the faculties involved in the management of these drugs must know them in depth, to decide the best treatment for the patient. This position paper, from a group of experts in anticoagulation in Argentina, can help the general practitioner in the daily use of direct oral anticoagulants based on the new evidence and the experience of a wide group of professionals. The way we relate to the anticoagulant treatment has changed in the last years. The doctors who work with them must also do so.

Advances in applied research of Rivaroxaban in children with thromboembolic disease / 中华实用儿科临床杂志

Rivaroxaban has been widely used for prevention and treatment of pulmonary embolism in adults due to the convenience of oral taking, rapid effect, less drug interaction, less influence by diet, no need of monitoring and fixed dose.However, its clinical application in children has been controversial.The EINSTEIN-Jr clinical trial and case reports at home and abroad have demonstrated the safety and effectiveness of Rivaroxaban in children with venous thrombus embolism.Therefore, Rivaroxaban can be considered as an alternative to standard anticoagulant therapy for children with venous thrombus embolism.This study reviews the application progress of Rivaroxaban in children with thromboembolic diseases.

Experiencia con idarucizumab como agente reversor de dabigatran / Experience with idarucizumab as a reverse agent of dabigatran

Resumen Los anticoagulantes orales directos (AOD), entre ellos dabigatrán, poseen un perfil riesgo-beneficio favorable comparados con warfarina y además no requieren monitoreo del efecto anticoagulante. Sin embargo, en ocasiones de sangrado con amenaza de vida o requerimiento de procedimiento quirúrgico de emergencia, es de gran utilidad revertir inmediatamente el efecto anticoagulante. Idarucizumab, fragmento de un anticuerpo monoclonal humanizado, revierte inmediatamente el efecto de dabigatrán y es actualmente el único agente reversor de un AOD disponible en Argentina. Presentamos una serie de 8 pacientes a los que se les administró idarucizumab para revertir el efecto de dabigatrán. Todos eran mayores de 65 años, recibían 110 o 150 mg cada 12 horas de dabigatrán y 7/8 estaban anticoagulados por fibrilación auricular; tres tenían indicación discutida para AOD y otro, una dosis mayor a la recomendada. Dos requirieron reversión debido a una cirugía de urgencia, y 6 tuvieron sangrado con amenaza de vida: tres hemorragias digestivas y tres sangrados intra-craneanos (en dos ocasiones traumático). En todos los casos se observó normalización de la hemostasia quirúrgica o control de sangrado crítico. No se observaron complicaciones trombóticas posteriores a la administración del antídoto. Dos fallecieron dentro de los 30 días de la administración por causas no relacionadas con la reversión. Ninguno de nuestros pacientes requirió administración de una segunda dosis de idarucizumab. Nuestro resultado es similar a lo informado en la literatura internacional.

Abstract Direct oral anticoagulants (DOACs), among them dabigatran, have a favorable benefit-risk profile compared with warfarin, and no monitoring of the anticoagulant effect is required. However, reversing the anticoagulant effect immediately is very useful in cases of life-threatening bleeding and emergency surgical procedure requirement. Idarucizumab, a humanized monoclonal antibody fragment, is currently the only reversal agent of a DOAC available in Argentina. Idarucizumab immediately reverse the effect of dabigatran. We present a series of 8 real-life clinical cases who received idarucizumab to reverse the effect of dabigatran. All of the patients were older than 65 years, were receiving 110 or 150 mg every 12 hours of dabigatran and 7/8 were anticoagulated because of atrial fibrillation. Three had a debatable indication for DOACs and another, a higher dose than recommended. Two required reversal due to emergency surgery, and 6 cases had life-threatening bleeding: three gastrointestinal hemorrhages and three intracranial bleeding (Two had a head trauma). In all cases normalization of surgical hemostasis or control of critical bleeding was observed. No hemorrhagic or thrombotic complications were observed after antidote administration. Two died within 30 days of administration of idarucizumab, due to causes unrelated to the reversal. None of our patients required administration of a second dose of idarucizumab. Our result is similar to that reported in international literature.

Pharmacogenomic Research in Direct Oral Anticoagulants / 中国医学科学院学报

Oral anticoagulants play an important role in the prevention and treatment of thromboembolic diseases.Warfarin,a traditional oral anticoagulant,is limited in clinical use due to its limitations such as narrow therapeutic window and requirements on frequent monitoring and dose adjustment.Direct oral anticoagulants(DOACs)such as dabigatran,rivaroxaban,apixaban,and edoxaban are increasingly used to prevent and treat venous thrombosis or thrombus formation.However,recent studies have documented inter-individual variability in plasma drug levels of DOACs.This article summarizes the recent advances in the pharmacogenomics of DOACs.

A Case of Mitral Mechanical Valve Thrombosis after Switching to Edoxaban / 日本心臓血管外科学会雑誌

A 65-year-old man who had been taking warfarin for a mitral mechanical valve, was transported to our hospital for acute heart failure 3 months after switching to edoxaban. The fluoroscopy revealed restriction of the mechanical valve opening, and the catheterization showed an increased pressure gradient of the mechanical valve. The patient was diagnosed with valve thrombosis, and emergency redo mitral valve replacement was performed. The patient recovered well without complication. In cases with mechanical heart valves, sufficient explanation and education about warfarin administration is mandatory for patients' home doctors as well as patients and their families.

Current Management of Cancer-associated Venous Thromboembolism: Focus on Direct Oral Anticoagulants

Cancer-associated venous thromboembolism (CAT) is a common complication associated with high morbidity and mortality. In accordance with major clinical trials comparing low-molecular-weight heparin (LMWH) with a vitamin K antagonist (VKA), LMWH is currently the standard treatment for CAT, owing to its efficacy for thrombosis recurrence and improved safety profile compared to VKA. Over the past few years, direct oral anticoagulants (DOACs) have emerged as potential alternative therapies to LMWH due to their convenient route of administration and predictable pharmacokinetics, but evidence for their use in CAT is inconclusive, as only a small fraction of the study populations in these trials had CAT. Recently, two large head-to-head trials comparing DOACs to LMWH in CAT patients reported comparable efficacies of DOACs with increased bleeding risk. Occasionally, CAT treatment can be challenging due to the heterogeneity of underlying malignancies and comorbidities. Renal insufficiency and gastrointestinal defects are the main obstacles in anticoagulant selection. Careful choice of treatment candidates and proper anticoagulant strategies are critical for the treatment of CAT; hence, more studies are required to address these challenges.

Practical guide to choosing dabigatran 150 mg twice daily or apixaban 5 mg twice daily for patients with atrial fibrillation / Journal of Rural Medicine

Based on previous reports, we propose a practical guide to choose dabigatran 150 mg twice daily or apixaban 5 mg twice daily for patients with atrial fibrillation. We recommend the use of dabigatran 150 mg twice daily for patients with atrial fibrillation who have a high risk of embolism (e.g., ischemic stroke on other oral anticoagulants, presence of left atrial appendage thrombus) and a low risk of bleeding. However, the prevalence of such patients with atrial fibrillation is considered low because patients with atrial fibrillation with a high risk of embolism usually have a high risk of bleeding. In most other patients with atrial fibrillation, the use of apixaban 5 mg twice daily should be considered.

Use of direct oral anticoagulants for chronic thromboembolic pulmonary hypertension

OBJECTIVES: Chronic thromboembolic pulmonary hypertension is one of the most prevalent forms of pulmonary hypertension and is a major complication of acute pulmonary embolism. One mainstay of chronic thromboembolic pulmonary hypertension treatment is lifelong anticoagulation. The recent advent of direct oral anticoagulants for acute pulmonary embolism treatment has provided a viable and effective alternative for treating this condition. However, little is known about the efficacy of this new class of drugs for treating chronic thromboembolic pulmonary hypertension. We aimed to evaluate the safety and efficacy of direct oral anticoagulants in the treatment of chronic thromboembolic pulmonary hypertension. METHODS: A cohort of chronic thromboembolic pulmonary hypertension patients who initiated treatment with direct oral anticoagulants between June 2015 and November 2016 were enrolled in this study. RESULTS: Sixteen patients used rivaroxaban, three used dabigatran and one used apixaban for a mean follow-up of 20.9 months. The mean age was 51 years, and eighteen patients were classified as functional class II/III. Eight patients underwent a pulmonary endarterectomy and exhibited clinical, hemodynamic and functional improvement and currently continue to use direct oral anticoagulants. No episode of venous thromboembolism recurrence was identified during the follow-up period, but there was one episode of major bleeding after a traumatic fall. CONCLUSIONS: Although direct oral anticoagulants appear to be a safe and effective alternative for treating chronic thromboembolic pulmonary hypertension, larger studies are needed to support their routine use.

Nuevos anticoagulantes orales y antiagregantes plaquetarios, en el período perioperatorio de cirugía no cardíaca. Parte 1: Nuevos anticoagulantes directos / Novel oral anticoagulants and new platelet antiaggregants, in the perioperative period of non cardiac surgery. Part 1: New direct oral anticoagulants

Due to the high frequency of patients with atrial fibrillation, thromboembolic disease, users of mechanical prosthetic valves, among other pathologies, in addition to their established use and advantages over vitamin K inhibitors, the use of novel oral anticoagulants (NOAC) is becoming more frequent in the perioperative period. The anesthesiologist must consider the thromboembolic risk of the patient, risk of bleeding, the half-life of the NOAC in used, in addition to the patients renal and hepatic function. Rivaroxaban and Apixaban should be suspended according to the risk of surgical bleeding, 24 to 36 hours before a surgery with a low risk of bleeding and 48 hours for high. In the case of Dabigatran, these times should be extended. These drugs are safe in the perioperative period and in most cases, it is not necessary to do a bridging therapy with heparin. The reversal of this type of drugs is also of special interest, currently available with specific methods for dabigatrán. Antidotes for other drugs are being studied. The decision of using a neuraxial block should be evaluated according to the time in which the patient discontinued the drugs and their renal function, specially in the case of Dabigatran.

Por la alta frecuencia de pacientes con fibrilación auricular, enfermedad tromboembólica, usuarios de válvulas protésicas mecánicas, entre otras patologías, además, de su establecido uso y ventajas con respecto a los inhibidores de vitamina K, cada vez es más frecuente el uso de los nuevos anticoagulantes orales (NACO) en el perioperatorio. Su manejo tiene características especiales. Debemos considerar el riesgo tromboembólico del paciente, de sangrado, la vida media del NACO utilizado, además de las funciones depurativas del organismo. Rivaroxaban y apixaban deben ser suspendidos según el riesgo de sangrado quirúrgico, 24 a 36 horas previo a una cirugía de bajo riesgo de sangrado y 48 horas para una de alto riesgo. En el caso del Dabigatrán y por la importancia de la función renal en su eliminación, estos tiempos deben extenderse. Estos fármacos son seguros en el perioperatorio y en la mayor parte de los casos no es necesario hacer terapia puente con heparina. La reversión es también de especial interés. Actualmente, se dispone con métodos específicos para dabigatrán y potenciales antídotos para los otros fármacos. La posibilidad de realizar un bloqueo neuroaxial debe ser evaluado según el tiempo en que el paciente suspendió los medicamentos y su función renal en caso de Dabigatrán.

New direct oral anticoagulants and associated gastrointestinal bleeding: Research progress / 第二军医大学学报

A new type of direct oral anticoagulants (DOACs) was approved for the prevention of thrombotic stroke in patients with nonvalvular atrial fibrillation and for treatment of venous thrombosis (VTE)/pulmonary infarction (PE) in 2010. Compared with the traditional oral anticoagulant vitamin K antagonist (VKA), DOACs have similar anticoagulant effect, better safety, easier administration and less intracranial hemorrhage, but it may increase the risk of gastrointestinal bleeding. As the half-life of DOACs is short, most gastrointestinal bleeding caused by DOACs does not require special treatment, but in rare situations, such as life-threatening bleeding or emergency surgery, DOACs reversal agent was needed to resist the anticoagulation of DOAC. In this review, we summarized the current status of DOACs, incidence of DOACs associated gastrointestinal bleeding, related prophylaxis and DOACs-specific reversal agents.

Trombocitopenia inducida por heparina: Nuevas opciones terapéuticas / Heparin-induced thrombocytopenia. New therapeutical options

La trombocitopenia inducida por heparina (TIH) es una reacción adversa inmunológica mediada por la formación de anticuerpos contra el complejo heparina-factor plaquetario 4 (FP4), caracterizada por la presencia de trombocitopenia y la asociación paradojal de trombosis arterial o venosa. Es una complicación poco frecuente pero grave del uso de cualquier tipo de heparina. En tratados con procedimientos cardiovasculares como intervención coronaria percutánea y cirugía de revascularización cardiaca, la prevalencia de anticuerpos es significativamente mayor que en otros escenarios clínicos. El reconocimiento de las características clínicas y de laboratorio permite la suspensión inmediata de la heparina y la instauración de tratamiento anticoagulante alternativo, para evitar la progresión y formación de nuevos trombos y sus complicaciones. En la presente revisión se resumen las diferentes alternativas terapéuticas para la TIH, en particular los anticoagulantes orales directos (DOACS) como el dabigatran, rivaroxaban y apixaban que pueden proporcionar una nueva opción para el tratamiento de TIH.

Heparin-induced thrombocytopenia (HIT) is an immune-mediated adverse reaction due to antibodies to a multimolecular complex of heparin and platelet factor 4 (PF4) characterized by moderate thrombocytopenia and paradoxical arterial or venous thrombosis. It is a relatively infrequent complication related to the administration of any type of heparin. In patients undergoing percutaneous coronary revascularization or coronary artery by-pass graft the prevalence of HIT is higher than in other clinical settings. Recognizing clinical and laboratory features of HIT allow immediate discontinuation of heparin and the use of alternative anticoagulants to avoid serious thrombotic complications. In this review, we summarize different therapeutic options for the treatment of HIT with special emphasis on direct oral anticoagulants (DOACS) such as dabigatran, rivaroxaban and apixaban. DOACS might represent a therapeutic alternative for HIT treatment.

Anticoagulantes orales directos y un cambio en el paradigma del monitoreo de la anticoagulación / New direct oral anticoagulants, a paradigm shift in haemostasis assays / Anticoagulantes orais diretos e uma mudança no paradigma da monitorização da anticoagulação

Los nuevos anticoagulantes orales directos (DOACs) son agentes sintéticos dirigidos en forma específica contra el factor Xa o contra la trombina. Por su farmacocinética predecible y escasa variabilidad interindividual no es necesario el monitoreo de anticoagulación. Esto es un cambio en el paradigma del tratamiento anticoagulante. Sin embargo, los DOACs alteran las pruebas de hemostasia y es importante saber cómo interpretarlas en caso de hemorragia, episodio trombótico o ante una cirugía de urgencia. Las pruebas clásicas de coagulación solo sirven para orientar sobre el efecto anticoagulante de los DOACs. Se debe conocer, para cada agente, cuál de las pruebas es útil, el reactivo que se utilizó y el tiempo transcurrido desde la ingesta del medicamento. Las pruebas específicas miden la concentración del DOAC. Son más sensibles, pero no han sido investigadas en relación a eventos clínicos y poseen una gran variación interindividual. Se concluye que hasta ahora no se cuenta con pruebas validadas para definir si se debe ajustar la dosis de los DOACs, aún en pacientes con alto riesgo hemorrágico. Nuevos estudios clínicos que utilizan diferentes pruebas de hemostasia serán de utilidad para ayudar a interpretar el efecto de los DOACs. Hasta que esto suceda, se tendrá que convivir con este nuevo paradigma, la ausencia del monitoreo.

New oral direct anticoagulants (DOACs) are synthetic agents targeting either thrombin or factor Xa. Their predictable pharmacokinetics and scarce variability eliminate the need for regular coagulation monitoring. This is a paradigm shift in anticoagulation treatment. However, DOACs interfere with coagulation assays and it is very important to recognize them in a bleeding or thrombotic event or in an urgent surgery. Commonly used screening coagulation tests are of limited utility and different test reagents, what kind of test to perform for each anticoagulant and the time of drug intake must be considered. Specific assays can accurately quantify drug levels, but they are not yet related to clinical events and there is great inter-individual variability. As a conclusion,there are no laboratory assays developed to support dose adjustment based on these test results. New clinical trials with laboratory measurement will help solve this. Until then, this new paradigm of no laboratory testing in routine clinical practice will have to be accepted.

Os novos anticoagulantes orais diretos (DOACs) são agentes sintéticos dirigidos em forma específica contra o fator Xa ou contra a trombina. Devido a sua farmacocinética previsível e escassa variabilidade interindividual não é necessária a monitoração de anticoagulação. Essa é uma mudança no paradigma do tratamento anticoagulante. Entretanto, os DOACs alteram as provas de hemostasia e é importante saber de que maneira interpretá-las em caso de hemorragia, episódio trombótico ou diante de uma cirurgia de urgência. Os testes clássicos de coagulação apenas servem para orientar a respeito do efeito anticoagulante dos DOACs. É necessário conhecer, para cada agente, qual dos testes é útil, o reagente que foi utilizado e o tempo decorrido desde a ingestão do medicamento. Os testes específicos medem a concentração do DOAC. São mais sensíveis, mas não foram pesquisados em relação a eventos clínicos e possuem grande variação interindividual. A conclusão é que até o momento não se conta com provas validadas para definir se deve ser ajustada a dosagem dos DOACs, mesmo em pacientes com alto risco hemorrágico. Novos estudos clínicos utilizando diferentes testes de hemostasia serão de utilidade para ajudar-nos a interpretar o efeito dos DOACs. Até que isto aconteça, será preciso conviver com este novo paradigma, a ausência da monitorização.

Agentes antitrombóticos en Terapia Intensiva: manejo práctico de los nuevos anticoagulantes orales directos / Antithrombotic agents in Intensive therapy: management practical of the new oral oral anticoagulants

Los nuevos anticoagulantes orales compiten actualmente, con alguna ventaja, con la terapéutica tradicional en la prevención de la cardioembolia en fibrilación auricular, y en la prevención y el tratamiento de la enfermedad tromboembólica venosa. Estudios recientes han demostrado una eficacia equivalente a la de los antagonistas de la vitamina K, con un mejor perfil de seguridad. Además, superan algunos inconvenientes de estos antagonistas, como la necesidad de ajuste de dosis y el monitoreo frecuente de la RIN, las múltiples interacciones farmacológicas y los cuidados con la dieta. Pero con los nuevos agentes debemos ser cautos, porque el riesgo de sangrado puede aumentar significativamente en ciertos grupos de pacientes con insuficiencia renal, añosos o muy frágiles. Aunque se emplean usualmente en dosis fijas, en casos especiales (peso <50 kg, edad avanzada, disfunción renal, alto riesgo de sangrado), esta dosis se debe modificar. Si bien, en la práctica clínica, no es necesario hacer pruebas de monitoreo de la coagulación, no contamos con pruebas adecuadas para evaluar su eficacia clínica y tampoco tenemos hoy, en nuestro medio, un antídoto eficaz en caso de sangrado importante. Sin embargo, se están realizando estudios con nuevas pruebas de hemostasia que pueden ayudarnos a interpretar el nivel de anticoagulación en estos pacientes y ya se han desarrollado antídotos para algunos de los anticoagulantes de acción directa que pronto estarán disponibles en nuestro medio.(AU)

New oral anticoagulants represent an interesting alternative to traditional therapy for the prevention of stroke in atrial fibrillation, and the thromboprophylaxis and treatment of venous thromboembolic disease. Several studies demonstrated equivalent efficacy to that of vitamin K antagonists with a more favourable safety profile. New oral anticoagulants overcome some of the main problems of these antagonists: the need of tailoring dosing, frequent interactions with other drugs and diet. But physicians have to keep in mind that new oral anticoagulants are not absolutely free of complications, and must be cautious with patients at high risk of bleeding. Also in special cases (<50 kg, advanced age, renal impairment) the usual dose must be adapted. At present there are not specific tests to evaluate the effect of these new anticoagulants, although it is usually not necessary to do any coagulation test in clinical practice. Another concern regarding new oral anticoagulants is the absence of specific antidotes, although specific antidotes are under clinical investigation and are soon going to be available in our country.(AU)