Riesgo de sangrado en pacientes anticoagulados con antagonistas de la vitamina K que reciben antibióticos / Risk of bleeding in anticoagulated patients with vitamin K antagonists who receive antibiotics

Lograr un adecuado nivel de anticoagulación con antagonistas orales de la vitamina K suele ser un desafío frecuente en la práctica clínica, dado que su estrecho rango terapéutico suele verse afectado por diversas interacciones farmacológicas,alimentos y condiciones clínicas. A partir de un caso de un paciente anticoagulado que presenta una hemorragia gastro-intestinal posterior a realizar un tratamiento antibiótico, la autora de este artículo revisó la evidencia sobre el riesgo desangrado secundario a la interacción entre este tipo de anticoagulantes y antibióticos orales. Su conclusión tras realizar una búsqueda bibliográfica y seleccionar la mejor evidencia disponible, es que existe un aumento del riesgo relativo desangrado en pacientes anticoagulados que reciben antibióticos, por lo que deberían evitarse aquellos antibióticos con conocido potencial de interacción. Si ello no fuera posible, se recomienda monitorizar el estado de anticoagulación con dosaje de la razón internacional normatizada (RIN) posterior a la introducción del antibiótico. (AU)

Achieving an adequate level of anticoagulation with oral vitamin K antagonists is often a frequent challenge in clinical practice, given that their narrow therapeutic range is often affected by various drug interactions, food, and clinical conditions. Based on a case of an anticoagulated patient who presented gastrointestinal bleeding after antibiotic treatment, the authorof this article reviewed the evidence on the risk of secondary bleeding due to the interaction between this type of anticoagulants and oral antibiotics. Their conclusion, after performing a literature search and selecting the best available evidence, is that there is an increased relative risk of bleeding in anticoagulated patients receiving antibiotics, so antibiotics with known potential for interaction should be avoided. If it weren't possible, it is recommended to monitor the anticoagulation status with International Normalized Ratio (INR) dosing after the introduction of the antibiotic. (AU)

Glucocorticoides en hemorragia alveolar por leptospira / Glucocorticoids in leptospira alveolar hemorrhage

Resumen Se presentan los casos clínicos de dos pacientes que ingresaron en la guardia de Emergencias del HIGA San Martín de La Plata con un cuadro clínico compatible con leptospirosis, que evolucionaron con insuficiencia respiratoria y hemorragia alveolar. En ambos se administraron glucocorticoides con buena evolución. Se realizó una búsqueda bibliográfica de artículos publicados desde 2005 en castellano e inglés y la revisión del tema. Basada en la evidencia actual no se puede hacer una clara recomendación para el uso de corticoides en la leptospirosis grave. La bibliografía publicada es escasa y de baja calidad. Aparentemente habría un beneficio en el uso de corticoides en los casos de afectación pulmonar por leptospirosis grave. Se necesitan estudios de alta calidad para realizar recomendaciones con evidencia científica, para verificar la dosis adecuada de corticoides, tiempo de inicio, duración del tratamiento y los casos en los que se debería administrar esta terapéutica.

Abstract We present the clinical cases of two patients who were admitted to the HIGA San Martín de La Plata emergency ward with a clinical picture compatible with leptospirosis, who evolved with respiratory failure and alveolar hemorrhage. In both, glucocorticoids were administered with good evolution. A bibliographic search of articles published since 2005 in Spanish and English and a review of the topic was carried out. Based on the current evidence, no clear recommendation can be made for the use of corticosteroids in severe leptospirosis. The published bibliography is scarce and of low quality. There would appear to be a benefit in the use of corticosteroids in cases of pulmonary involvement due to severe leptospirosis. High-quality studies are needed to make recommendations with scientific evidence, to verify the adequate dose of corticosteroids, time of initiation, duration of treatment and the cases in which this therapy should be administered.

Aspirina en la prevención primaria. Metaanálisis estratificado por riesgo cardiovascular basal / Aspirin in primary prevention. Meta-analysis stratified by baseline cardiovascular risk

Resumen Introducción: La utilidad de la aspirina en la prevención primaria es todavía objeto de controversia. Los avances médicos y la variabilidad del riesgo cardiovascular podrían explicar la heterogeneidad de los estudios publicados, y las poblaciones de alto riesgo tendrían mayor beneficio. Objetivo: Analizar los efectos de la aspirina en pacientes sin antecedentes cardiovasculares y evaluar los resultados de acuerdo con el riesgo cardiovascular de las poblaciones. Métodos: Se incluyeron estudios que evaluaron el uso de la aspirina en comparación con placebo en la prevención primaria. Se analizó la combinación de muerte cardiovascular, infarto agudo de miocardio (IAM) y accidente cerebrovascular (ACV) isquémico. El punto final de seguridad fue la combinación de ACV hemorrágico y sangrado mayor. Se clasificaron los estudios en riesgo bajo y moderado/ alto, de acuerdo con el número de episodios en la rama de placebo. Resultados: Se evaluaron 13 estudios (n = 164,225), ocho de riesgo cardiovascular bajo (n = 118,455) y cinco de moderado/alto (n = 45,770). Se observó una reducción del punto final combinado en el grupo de aspirina (OR 0.90; IC 95%, 0.85-0.94), sin diferencias en mortalidad cardiovascular (OR 0.94; IC 95%, 0.86-1.04). No se identificaron diferencias entre los subgrupos de riesgo. Se reconocieron mayores complicaciones hemorrágicas en el grupo de aspirina (OR 1.45; IC 95%, 1.32-1.60), sin diferencias entre los subgrupos de riesgo. Conclusión: La aspirina se relacionó con una leve disminución de IAM y ACV isquémico en términos absolutos, sin diferencias en la mortalidad cardiovascular. Esto, junto con el aumento de las complicaciones hemorrágicas, se traduce en una ausencia de beneficio clínico neto. El riesgo cardiovascular basal de la población no modificó los resultados.

Abstract Background: The usefulness of aspirin in primary prevention continues to be the subject of debate. Medical advances and the variability of cardiovascular risk could explain the heterogeneity of the published studies. High risk populations would have greater benefit. Objective: Analyzing the effects of aspirin in patients without cardiovascular disease and evaluating the results according to the cardiovascular risk of the populations. Methods: Studies evaluating aspirin versus placebo in primary prevention were included. The primary endpoint was the combined cardiovascular death, acute myocardial infarction (AMI) and ischemic stroke. The final safety point was the combination of hemorrhagic stroke and major bleeding. The studies were classified into low and moderate/high risk, according to the number of events in the placebo arm. Results: Thirteen studies were evaluated (n = 164,225), eight of low cardiovascular risk (n = 118,455) and five of moderate/high risk (n = 45,770). There was a reduction of the combined endpoint in the aspirin group (odds ratio [OR] 0.90; 95% confidence interval [CI], 0.85-0.94), without differences in cardiovascular mortality (OR 0.94; 95% CI, 0.86-1.04). No differences were observed when comparing the risk subgroups. Greater hemorrhagic complications were observed in the aspirin group (OR 1.45; 95% CI, 1.32-1.60), without differences between the risk subgroups. Conclusion: Aspirin was associated with a slight decrease in AMI and ischemic stroke in absolute terms, with no differences in cardiovascular mortality. This accompanied by the increase in hemorrhagic complications, results in an absence of net clinical benefit. The baseline cardiovascular risk of the population did not affect the results.

SBA 2020: Regional anesthesia guideline for using anticoagulants update / SBA 2020: Atualização na diretriz da anestesia regional em uso de anticoagulantes

Abstract The development of protocols to prevent perioperative Venous Thromboembolism (VTE) and the introduction of increasingly potent antithrombotic drugs have resulted in concerns of increased risk of neuraxial bleeding. Since the Brazilian Society of Anesthesiology 2014 guideline, new oral anticoagulant drugs were approved by international regulating agencies, and by ANVISA. Societies and organizations that try to approach concerns through guidelines have presented conflicting perioperative management recommendations. As a response to these issues and to the need for a more rational approach, managements were updated in the present narrative review, and guideline statements made. They were projected to encourage safe and quality patient care, but cannot assure specific results. Like any clinical guide recommendation, they are subject to review as knowledge grows, on specific complications, for example. The objective was to assess safety aspects of regional analgesia and anesthesia in patients using antithrombotic drugs, such as: possible technique-associated complications; spinal hematoma-associated risk factors, prevention strategies, diagnosis and treatment; safe interval for discontinuing and reinitiating medication after regional blockade.

Resumo Os padrões evolutivos para a prevenção do tromboembolismo venoso perioperatório e a introdução de medicações antitrombóticas cada vez mais potentes resultaram em preocupações com o aumento do risco de sangramento neuroaxial. Após o consenso da Sociedade Brasileira de Anestesiologia em 2014, novos medicamentos anticoagulantes orais foram aprovados pelas instituições reguladoras internacionais, assim como pela ANVISA. As sociedades que buscam abordar o manejo perioperatório desses fármacos apresentam recomendações conflitantes. Em resposta a essas questões e à necessidade de uma abordagem mais racional, as condutas foram atualizadas nesta revisão narrativa e feitas declarações de consenso. Elas foram projetadas para encorajar a assistência ao paciente de forma segura e de qualidade, mas não podem garantir um resultado específico. Tal como acontece com qualquer recomendação de orientação clínica, estas estão sujeitas a revisão com o conhecimento de avanços específicos de complicações. O objetivo foi avaliar aspectos da segurança em anestesia e analgesia regional em pacientes em uso de medicações antitrombóticas, tais como: possíveis complicações decorrentes da técnica; fatores de risco associados ao hematoma espinhal, estratégias de prevenção, diagnóstico e tratamento; intervalo seguro para suspensão e reinício da medicação após o bloqueio regional.

Thrombolysis in acute pulmonary embolism

SUMMARY OBJECTIVES Acute pulmonary embolism (APE) is an important cause of cardiovascular mortality, due mainly to hemodynamic instability. In these cases, the recommendation is to perform some reperfusion procedure, with systemic thrombolysis being the main therapy used. However, national data evaluating the efficacy and safety of thrombolysis are scarce. METHODS Retrospective analysis of a case series. We included 13 patients diagnosed with high-risk APE and 4 patients with intermediate-high risk from a single-center, who were treated with alteplase 100mg. RESULTS The mean age of the patients was 55 years, most of them female (76.4%). Among the risk factors for VTE were immobilization (41.17%), contraceptive use (35.29%), cancer (17.63%), and previous history of DVT (11.76%). The most frequent clinical manifestations of APE were dyspnea (88.23%), hypoxia (82.35%), hypotension (82.35%), and tachycardia (64.70%). 82.35% of the patients had echocardiographic signs of right ventricular dysfunction, and 52.94% had increased troponin and BNP. Severe bleeding associated with thrombolysis occurred in 17.54% of cases. No patient died due to bleeding. There were 8 deaths from right ventricular failure (47%), 6 in the cases of patients presenting as high-risk APE (35.3%), and 2 in the cases of intermediate-high risk (11.8%). CONCLUSION Thrombolysis in patients with high-risk APE or intermediate-high risk had a severe bleeding rate of 17.6%. However, the high mortality of this population (47%) due to right ventricular failure justifies the use of this therapeutic modality.

RESUMO OBJETIVOS A embolia pulmonar aguda (EAP) é uma causa importante de mortalidade cardiovascular ao causar instabilidade hemodinâmica. Nesses casos, a recomendação é a realização de algum procedimento de reperfusão, sendo a trombólise sistêmica a principal terapia utilizada. No entanto, dados nacionais avaliando a eficácia e a segurança da trombólise são escassos. MÉTODO Análise retrospectiva de uma série de casos. Foram incluídos 13 pacientes com o diagnóstico de EAP de alto risco e quatro pacientes de risco intermediário-alto, de um único centro, e que foram tratados com alteplase 100 mg. RESULTADOS A média de idade dos pacientes foi 55 anos, sendo a maioria do gênero feminino (76,4%). Dos fatores de risco para TEV, estavam presentes a imobilização (41,17%), o uso de anticonceptivos (35,29%), câncer (17,63%) e história prévia de TVP (11,76%). As manifestações clínicas mais frequentes da EAP foram dispneia (88,23%), hipóxia (82,35%), hipotensão (82,35%) e taquicardia (64,70%); 82,35% dos pacientes apresentaram sinais ecocardiográficos de disfunção ventricular direita e 52,94% apresentaram aumento da troponina e BNP. Sangramento grave associado à trombólise ocorreu em 17,54% dos casos. Nenhum paciente faleceu em decorrência de sangramento. Houve oito mortes por insuficiência ventricular direita (47%): seis nos casos de paciente que se apresentaram como EAP de alto risco (35,3%) e duas nos casos de risco intermediário-alto (11,8%). CONCLUSÃO A trombólise nos pacientes com EAP de alto risco ou risco intermediário-alto apresentou uma taxa de sangramento grave de 17,6%. No entanto, a alta mortalidade dessa população (47%) por insuficiência ventricular direita justifica o uso desta modalidade terapêutica.

Pacientes con fibrilación auricular no valvular tratados con antivitamina K o anticoagulantes directos: perfil de paciente y efectos a largo plazo / Patients with non-valvular atrial fibrillation on vitamin k antagonists or direct-acting oral anticoagulants: patients profile and long-term follow up outcomes

Resumen Introducción: La llegada de los anticoagulantes directos (ACD) ha supuesto un cambio en el tratamiento de la fibrilación auricular no valvular (FANV) en los últimos años. Los objetivos de este estudio son determinar el grado de control de la anticoagulación con antivitamina K (AVK) y su posible implicación en efectos cardiovasculares adversos mayores (ECAM) y evaluar las diferencias entre el grupo en tratamiento con AVK respecto del grupo con ACD. Pacientes y métodos: Estudio de cohorte prospectivo que incluyó a pacientes consecutivos diagnosticados con FANV valorados en el Servicio de Cardiología con un seguimiento de 18 meses. Se analizaron diferencias demográficas, clínicas y analíticas entre grupos, incluido el grado de control de la anticoagulación del grupo AVK y su posible relación con ECAM. Resultados: Se incluyó a 273 pacientes: 46.5% tratados con AVK, 42.5% con ACD y 11% sin tratamiento anticoagulante. El control de la anticoagulación con AVK fue del 62.1%, sin diferencias en ECAM en función de control. El grupo ACD presentó menos ECAM que el grupo de AVK (13.4 vs. 4.3%; HR, 0.90; 0.83-0.98; p = 0.01), con una menor mortalidad cardiovascular (0.0 vs. 5.5%; HR, 0.94; 0.90-0.98; p = 0.01) y total (0.9 vs. 12.6%; HR, 0.88; 0.82-0.94; p menor que 0,01), aunque sin diferencias significativas en eventos hemorrágicos (0.9 vs. 4.7%; p = 0.07) ni isquémicos (2.6 vs. 0.8%; p = 0.27). Discusión: Los pacientes con AVK poseen un perfil clínico diferente en comparación con los que reciben ACD. El control de anticoagulación del grupo de AVK fue inadecuado en casi la mitad de los casos. El grupo de AVK presentó más ECAM que el grupo de ACD.

Abstract Introduction: The arrival of direct-acting oral anticoagulants (DOACs) has led to a change in the management of non-valvular atrial fibrillation (NVAF) in recent years. The objectives of this study are to determine the level of therapeutic control of anticoagulation with vitamin K antagonists (VKA) and its possible involvement in major adverse cardiovascular events (MACE) and to evaluate differences between the group on VKA with respect to the group on DOACs. Patients and methods: Prospective cohort study that included consecutive patients diagnosed with NVAF in Cardiology Consultations with a clinical follow-up of 18 months. Demographic, clinical and analytical differences between groups were analyzed, including the level of therapeutic control of anticoagulation on the VKA group and its association with MACE. Results: Overall, 273 patients were included: 46.5% on VKA, 42.5% on DOACs, 11% without antithrombotic treatment. Patients on VKA spent 62.1% of their time within therapeutic range (TTR by the Rosendaal formule). There were no differences in MACE depending on anticoagulation control. The DOACs group presented lesser MACE rate than the VKA group (13.4 vs. 4.3%; 0.90; HR 0.90; 0.83-0.98 p = 0.01) with lower cardiovascular mortality (0.0 vs. 5.5%; HR, 0.94; 0.90-0.98; p = 0.01) and total mortality (0.9 vs. 12.6%; HR, 0.88; 0.82-0.94; p less 0.01) although without significant differences in hemorrhagic (0.9 vs. 4.7 %; p = 0.07), or ischemic events (2.6 vs. 0.8%, p = 0.27). Conclusions: Patients on VKA have a different clinical profile than those who receive DOACs. Patients on VKA have an inadequate control of the anticoagulation in quite the half of the cases. The VKA group presented more MACE than the DOACs group.

Left Atrial Appendage Transcatheter Occlusion with AMPLATZER™ Amulet™ Device: Real Life Data with Mid-Term Follow-Up Results / Oclusão Transcateter do Apêndice Atrial Esquerdo com a Prótese AMPLATZER™ Amulet™: Dados Reais com Resultados de Seguimento de Médio-Prazo

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 1st month evaluation, which disappeared at the 12th month follow-up. Conclusion: We concluded that LAA occlusion using the Amulet™ LAA occluder can be performed with high procedural success and acceptable outcomes.

Resumo Fundamento: A oclusão do apêndice atrial esquerdo (AAE) é uma terapia alternativa para pacientes com fibrilação atrial que tenham alto risco embólico e contraindicações à terapia anticoagulante. Objetivo: Avaliar a viabilidade, segurança e resultados de médio prazo da oclusão percutânea do AAE, incluindo a trombose relacionada à prótese. Métodos: Sessenta pacientes consecutivos que foram submetidos à oclusão percutânea do AAE com a prótese AMPLATZER™ Amulet™ de setembro de 2015 a março de 2018 foram incluídos no estudo. Os pacientes foram acompanhados por 21 ± 15 meses (mediana - 20 meses, intervalo interquartílico - 9 a 27 meses). A avaliação pós-procedimento foi feita no 1º, 6º e 12º mês. Os pacientes foram examinados clinicamente e um ecocardiograma transesofágico foi realizado a cada visita. A condição de normalidade das variáveis foi avaliada por meio do teste de Kolmogorov-Smirnov. Os valores de p < 0,05 foram considerados estatisticamente significativos. Resultados: A indicação mais comum para o procedimento foi sangramento significativo com anticoagulantes (n: 53, 88,3%). O procedimento foi concluído com sucesso em 59 (98,3%) pacientes. Mortalidade peri-procedimento ocorreu em um paciente. A tratamento antiplaquetário pós-procedimento foi planejado como terapia antiplaquetária única ou dupla ou terapia anticoagulante de dose baixa em 52 (88,1%), 2 (3,4%) e 5 (8,5%) pacientes, respectivamente. Não foram encontrados eventos cerebrovasculares clinicamente significativos, trombo relacionado à prótese ou embolização nos pacientes durante o seguimento. Dois (3,4%) pacientes apresentaram vazamento peri-prótese significativo (>3 mm) na avaliação do 1º mês, que desapareceu no 12º mês de seguimento. Conclusão: Concluiu-se que a oclusão do AAE com o oclusor de AAE Amulet™ pode ser realizada com grande sucesso e resultados aceitáveis.

Manejo de hemorragia asociada a anticoagulantes orales directos: estado actual de las estrategias de reversión / Management of bleeding associated with direct oral anticoagulants: update on reversal strategies

Direct oral anticoagulants (DOACs), including the direct thrombin inhibitor dabigatran and the direct factor Xa inhibitors rivaroxaban, apixaban and edoxaban have at least comparable efficacy as vitamin K antagonists along with a better safety profile, reflected by a lower incidence of intracranial hemorrhage. Specific reversal agents have been developed in recent years. Namely, idarucizumab, a specific antidote for dabigatran, is currently approved in most countries. Andexanet, which reverses factor Xa inhibitors, has been recently approved by the FDA, and ciraparantag, a universal antidote targeted to reverse all DOACs, is still under investigation. In this review we provide an update on the pharmacology of DOACs, the risk of hemorrhagic complications associated with their use, the measurement of their anticoagulant effect and the reversal strategies in case of DOAC-associated bleeding.

Uninterrupted Use of Oral Anticoagulants for the Ablation of Atrial Flutter: A Single Center Cohort of 154 Patients / Uso Ininterrupto de Anticoagulantes Orais na Ablação de Flutter Atrial Istmo-Cavotricuspídeo Dependente: Coorte Unicêntrica de 154 Pacientes

Abstract Background: The uninterrupted use of oral anticoagulation (OAC) with vitamin K antagonists (VKAs) for electrophysiology procedures has been more and more recommended. The clinical practice in our service recommends the continuous use of these drugs for atrial flutter ablation. There is little evidence as to the uninterrupted use of non-vitamin K antagonist oral anticoagulants (NOACs) in this scenario. Objective: To compare the rates of complications related with the uninterrupted use of different types of oral anticoagulants in patients referred to atrial flutter (AFL) ablation. Methods: Historical, single-center cohort of ablation procedures by AFL conducted from November 2012 to April 2016. The primary outcome was the occurrence of hemorrhagic or embolic complication during the procedure. The secondary outcome was the occurrence of stroke or transient ischemic attack (TIA) in follow-up. The statistical significance level was 5%. Results: There were 288 ablations per AFL; 154 were carried out with the uninterrupted use of OAC (57.8% with VKA and 42.2% with NOAC). Mean age was 57 ± 13 years. The rate of hemorrhagic complication during the procedure was 3% in each group (p = NS). The rate of stroke/TIA was, respectively, of 56/1,000 people-year in the VKA group against zero/1,000 people-year in the NOAC group (p = 0.02). Conclusion: In our population there were no hemorrhagic complications regarding the procedure of OAC use uninterruptedly, including NOACs. There was higher occurrence of stroke/TIA in the follow-up of the group of patients undergoing VKAs; however, this difference may not only be a result of the type of OAC used.

Resumo Fundamento: O uso ininterrupto de anticoagulação oral (ACO) com antagonistas da vitamina K (AVKs) para procedimentos de eletrofisiologia está sendo cada vez mais recomendado. A prática clínica em nosso serviço é de uso continuado dessas drogas para ablação de flutter atrial. Existem poucas evidências quanto ao uso ininterrupto dos anticoagulantes orais não antagonistas da vitamina K (NOACs) nesse cenário. Objetivos: Comparar as taxas de complicações relacionadas ao uso ininterrupto de diferentes tipos de anticoagulantes orais em pacientes referidos para ablação por flutter atrial (FLA). Métodos: Coorte histórica e unicêntrica dos procedimentos de ablação por FLA realizados no período de novembro de 2012 a abril de 2016. O desfecho primário foi o de ocorrência de complicação hemorrágica ou embólica durante o procedimento. O desfecho secundário foi o de ocorrência de acidente vascular cerebral (AVC) ou acidente isquêmico transitório (AIT) no acompanhamento. O nível de significância estatística adotado foi de 5%. Resultados: Foram incluídas 288 ablações por FLA; 154 foram feitas com uso ininterrupto de ACO (57,8% com AVK e 42,2% com NOAC). A idade média foi de 57 ± 13 anos. A taxa de complicação hemorrágica durante o procedimento foi de 3% em cada grupo (p = NS). A taxa de AVC/AIT foi, respectivamente, de 56/1.000-pessoas-ano no grupo AVK contra zero/1.000-pessoas-ano no grupo NOAC (p = 0,02). Conclusão: Em nossa população não ocorreram complicações hemorrágicas relacionadas ao procedimento com uso de ACO de forma ininterrupta, incluindo NOACs. Houve maior ocorrência de AVC/AIT no seguimento no grupo de pacientes em uso de AVK, contudo essa diferença pode não ser decorrente apenas do tipo de ACO em uso.

Anticoagulation in patients with cardiac manifestations of Chagas disease and cardioembolic ischemic stroke / Anticoagulação nas manifestações cardíacas da doença de Chagas e acidente vascular cerebral isquêmico cardioembólico

ABSTRACT Objectives To describe anticoagulation characteristics in patients with cardiac complications from Chagas disease and compare participants with and without cardioembolic ischemic stroke (CIS). Methods A retrospective cohort of patients with Chagas disease, using anticoagulation, conducted from January 2011 to December 2014. Results Forty-two patients with Chagas disease who were using anticoagulation were studied (age 62.9±12.4 years), 59.5% female and 47.6% with previous CIS, 78.6% with non-valvular atrial fibrillation and 69.7% with dilated cardiomyopathy. Warfarin was used in 78.6% of patients and dabigatran (at different times) in 38%. In the warfarin group, those with CIS had more medical appointments per person-years of follow-up (11.7 vs 7.9), a higher proportion of international normalized ratios within the therapeutic range (57% vs 42% medical appointments, p = 0.025) and an eight times higher frequency of minor bleeding (0.64 vs 0.07 medical appointments). Conclusion Patients with Chagas disease and previous CIS had better control of INR with a higher frequency of minor bleeding.

RESUMO Objetivos descrever as características da anticoagulação em pacientes com manifestações cardíacas da doença de Chagas (MCDC) e comparar os participantes com sem acidente vascular cerebral isquêmico cardioembólico (AVCIC). Resultados 42 pacientes com MCDC em anticoagulação foram estudados (62,9 ± 12,4 anos), 59,5% do sexo feminino e 47,6% com AVCIC prévio, 78,6% portadores de fibrilação atrial não valvar e 69,7% com cardiomiopatia dilatada. Varfarina foi utilizada em 78,6% dos pacientes e dabigatrana em 38% (em momentos diferentes). No grupo da varfarina, aqueles com AVCIC tiveram mais consultas médicas por pessoas-ano de seguimento (11,7 vs 7,9), maior taxa de RNI na faixa terapêutica (57% vs 42% consultas médicas, p = 0,025) e uma frequência oito vezes maior de sangramento menor (0,64 vs. 0,07 consultas médicas). Conclusão pacientes com MCDC e AVCIC prévio têm melhor controle de RNI com maior frequência de sangramento menor.

Evaluación de la estrategia de terapia antitrombótica posterior al cambio valvular aórtico con válvulas biológicas en pacientes de bajo riesgo trombótico / Evaluation of the antithrombotic strategy in low thrombotic risk patients who underwent aortic valve replacement with a bioprosthesis

Resumen De acuerdo a las guías actuales, aún es materia de debate el uso de anticoagulación en los primeros 3 meses en pacientes de bajo riesgo trombótico sometidos a cambio valvular aórtico con prótesis biológicas. En base a la evidencia actual, la aspirina a dosis bajas es razonable como alternativa a los antagonistas de la vitamina K (AVK) durante el posquirúrgico temprano en pacientes con prótesis biológicas en posición aórtica. Se comparó la incidencia de complicaciones trombóticas o hemorrágicas de acuerdo a la estrategia de terapia antitrombótica en los pacientes de bajo riesgo trombótico sometidos a cambio valvular aórtico con válvulas biológicas en el Instituto Nacional de Cardiología Ignacio Chávez. La hipótesis: la aspirina como monoterapia antitrombótica tiene un efecto benéfico comparado con los AVK. Se estudiaron los pacientes de bajo riesgo trombótico sometidos a cambio valvular aórtico con válvulas biológicas en el Instituto Nacional de Cardiología Ignacio Chávez. Se incluyeron los pacientes operados del año 2011 al 2015. Se identificó en el seguimiento a un año la presencia de complicaciones trombóticas o hemorrágicas y si se manejaron con cualquiera de las siguientes: aspirina únicamente, AVK solo y la combinación aspirina más AVK. Se analizaron 231 pacientes. Solo se presentó una complicación hemorrágica en un paciente tratado con AVK. No hubo complicaciones trombóticas. No se presentaron complicaciones trombóticas en pacientes que no recibieron anticoagulación oral formal durante los primeros 3 meses posquirúrgicos, lo que indica que es seguro el uso de aspirina como monoterapia en estos pacientes de bajo riesgo trombótico.

Abstract According to current guidelines, in patients without additional risk factors who have undergone aortic valve replacement with a bioprosthesis, anticoagulation in the first 3 months after surgery is still a matter of debate. According to current evidence, aspirin in low doses is a reasonable alternative to vitamin K antagonists (VKA). A comparison is made between the incidence of thrombotic and haemorrhagic complications in patients with low thrombotic risk who underwent aortic valve replacement with a bioprosthesis in the National Institute of Cardiology of Ignacio Chávez of Mexico. The hypothesis: aspirin as monotherapy has a beneficial effect compared to VKA. The studied patients were the low thrombotic risk patients who underwent aortic valve replacement with a bioprosthesis in the National Institute of Cardiology of Ignacio Chávez of Mexico from 2011 to 2015. The groups studied were: aspirin only, VKA only, and the combination of VKA plus aspirin. The patients were retrospectively followed-up for 12 months, and the thrombotic and haemorrhagic complications were documented. Of the 231 patients included in the study, only one patient in the VKA only group presented with a haemorrhagic complication. No thrombotic complications were observed. In the present study no thrombotic complications were observed in patients who did not receive anticoagulation in the first 3 months after an aortic valve replacement with a bioprosthesis after a follow up period of 12 months. This suggests that the use of aspirin only is safe during this period.

Uso de terapia antiagregante dual luego de angioplastía coronaria: duración, frecuencia de sangramientos y validación de scores de riesgo de hemorragia en una cohorte chilena / Dual anti platelet therapy post PTCA: duration, bleeding risk and validation of scores for predicting risk of bleeding in a Chilean population

Resumen: Introducción: La terapia antiagregante dual (TAD) con aspirina más clopidogrel o ticagrelor es fundamental para prevenir trombosis de stent y nuevos eventos cardiovasculares (CV) en pacientes sometidos a angioplastía coronaria (AC). Sin embargo, TAD se asocia a un riesgo aumentado de hemorragias, en particular cuando su uso se prolonga. Recientemente se han creado puntajes (DAPT, PRECISE-DAPT) que buscan estimar el riesgo de sangrado en pacientes con TAD por tiempo prolongado, los que quisimos evaluar en nuestra población. Métodos: Se utilizó la base de datos prospectiva de Prevención Cardiovascular del Hospital Clínico U. Católica, seleccionando pacientes sometidos a AC el año 2015. Se realizó una encuesta telefónica estandarizada para identificar episodios de sangrado definidos según clasificación ISTH, tiempo de uso de TAD y nuevos eventos CV. Se calcularon los puntajes DAPT y PRECISE-DAPT. Se usó pruebas de t de Student, test exacto de Fisher y curva ROC, según correspondiese, considerando significativa una p<0,05. Resultados: Se incluyeron 227 pacientes (edad 64,2±12,3 años, 22,5% mujeres), de los cuales el 69,6% eran hipertensos, 28,6% diabéticos, 26,9% fumadores y 5,3% insuficientes renales crónicos. En el 63% de los pacientes la AC fue por síndrome coronario agudo, se implantaron 1,4±0,7 stents/paciente y el 37% de los pacientes recibió sólo stents metálicos. Al momento de la encuesta, el seguimiento fue de 26±3 meses. Se registró un tiempo promedio de duración de TAD de 12,6±7,4 meses, con 99,1% de los pacientes recibiendo aspirina, 93,4% clopidogrel, 6,6% ticagrelor y 9,3% anticoagulantes orales. Hubo 35 (15,4%) nuevos eventos CV (revascularización 14, infarto 12, accidente cerebrovascular 2 y muerte 7) y 31 (13,6%) episodios de sangrados (criterio ISTH). De acuerdo con el criterio TIMI de sangrado se registraron 5 (2,2%) episodios graves, 9 (3,9%) leves y 17 (7,4%) menores. En 10 (4,4%) pacientes se modificó la TAD debido al sangrado. PRECISE-DAPT se asoció de manera significativa a los episodios de sangrado (p<0,01); tener un puntaje de alto riesgo (>25) aumentó más de 3 veces el riesgo de sangrado (OR 3,1 IC 1,4-7,1, p<0,01) y una curva ROC estableció que en la población estudiada el mejor punto de corte fue de 18 puntos (C-statistic 0,69) (Figuras 1A y B). El uso de TACO aumentó el riesgo (OR 3,4 IC 1,2-9,5, p=0,02). Si bien miden distintos parámetros, los puntajes de riesgo DAPT y PRECISE-DAPT se correlacionaron significativamente en nuestra cohorte (p<0,01). Conclusiones: En esta cohorte de la vida real se demuestra que la ocurrencia de sangramientos es un evento frecuente en pacientes con TAD, similar a la tasa de nuevos eventos CV, y por tanto debe ser un factor relevante a considerar al momento de la AC y la selección de la TAD. El puntaje PRECISE-DAPT es una herramienta útil para predecir sangrados, aunque nuestros resultados sugieren que en población chilena los valores de corte pueden ser algo menores que lo previamente publicado .

Abstracts: Background: Dual antiplatelet therapy (DAT) with aspirin plus clopidogrel or ticagrelor is essential for the prevention of stent thrombosis and new cardiovascular events in patients undergoing PCI. However, DAT is associated with an increased risk of bleeding, more so when it is used for prolonged time periods. Scores (DAPT, PRECISE-DAPT) developed to predict bleeding risk were evaluated in this study. Method: The prospective Cardiovascular Prevention database at Catholic University Hospital was used to select patients who underwent PCI followed by DAT during 2015. By phone contact information on bleeding episodes - according to the ISTH classification -, new cardiovascular events and DAT duration were collected. DAPT and PRECISE- DAPT scores were calculated. Student's t test, Fisher exact test and ROC analysis were used. Significance was established at p< 0.05. Results: 277 patients were included (age 64.2±12.3 y-o, 22.5% women). Hypertension was present in 66.9%, diabetes in 28.6%, smoking habit in 26.9% and renal failure in 5.3%. The indication for PCI was acute coronary syndrome in 63%, 1.4±0.7 stents per patient were implanted and 37% of patients received bare metal stents exclusively. Follow-up extended for 26±3 months. DAT was active for 12.6±7.4 months and 9.3% of patients received oral anticoagulant therapy. There were 35 (15.4%) new cardiovascular events (14 revascularizations, 12 myocardial infarctions, 2 CVA and 7 deaths). Conversely, there were 31 (13.6%) bleeding episodes. According to the TIMI classification, bleeding episodes were severe in 2.2%, mild in 3.9% and minor in 7.4%. In 4% of patients DAT was modified due to bleeding. PRECISE-DAPT score was significantly associated to bleeding episodes (p<0.01). A high score (>25) was associated with a 3-fold risk of bleeding (OR 3.1, CI 1.4-7.1 (p<0.01). Through ROC analysis the best PRECISE-DAPT cutting point in this cohort was 18 (C=0.69). The use of oral anticoagulation increased bleeding risk (OR 3.4 CI 1.2 - 9.5, p=0.02). DAPT and PRECISE-DAPT were significantly correlated (p<0.01). Conclusion: Bleeding is a frequent complication of DAT, similar to the risk of new cardiovascular events. PRECISE-DAPT score is useful to estimate the risk of bleeding, although this study suggests that in the studied population the cutting point may be somewhat lower than previously published.

Efectividad y seguridad del tratamiento anticoagulante con acenocumarol en fibrilación auricular no valvular / Effectiveness and safety of oral anticoagulation treatment with acenocoumarol in non-valvular atrial fibrillation

Background: Vitamin K antagonists significantly decrease the incidence of stroke but increase the risk of bleeding. Aim: To assess the effectiveness and risk of bleeding of vitamin K antagonists in non-valvular atrial fibrillation. Material and Methods: Retrospective cohort study of 524 patients, 236 women (45%) and 288 men (55%) with non-valvular atrial fibrillation (NVAF) admitted to the oral anticoagulation treatment (OAT) clinic at four public hospitals, between 2009 and 2012. They were followed until March 2013, measuring the quality of OAT, ischemic and bleeding events. Results: The mean follow-up was 26.1 months, with 1,154.7 person-years of follow-up accrued. The percentage of time in therapeutic range (TTR) was 35.2 ± 18%; this was deemed to represent the quality of OAT. The cumulative incidence of ischemic events, either stroke or systemic embolism, was 2.25/100 person-years, being greater in patients with previous embolism (Risk ratio 5.21, 95% confidence intervals 2.31- 11.73, p < 0.01). The cumulative incidence of major bleeding events-extracranial and intracraneal-was 4.08/100 person-years. The main site of extracranial major bleeding was the gastrointestinal tract (32%). Conclusions: In our clinical practice, the effectiveness of OAT with acenocoumarol in NVAF patients is similar to that published abroad. However, the incidence of bleeding complications is higher. The quality of the OAT measured by the TTR was lower than abroad.

Thromboembolism and bleeding risk scores and predictors of cardiac death in a population with atrial fibrillation / Escores de risco de tromboembolismo e de sangramento e preditores de morte cardíaca em uma população com fibrilação atrial

Abstract Background: Atrial fibrillation (AF) is a common arrhythmia, with risk of systemic embolism and death. It presents rheumatic etiology in up to 32% of developing countries, whose anticoagulation and evolution data are scarce. Objectives: to determine the predictors of cardiac death considering the clinical profile, thromboembolism and bleeding scores of patients with AF of a single center, with high prevalence of rheumatic heart disease. Methods: 302 patients with AF were studied, mean age 58.1 years; 161 women; 96 pts with rheumatic etiology. Patients underwent clinical and laboratory evaluation, measurement of risk scores and the mean follow-up of 12.8 months. Results: 174 were using warfarin. The averages of the HAS-BLED and ATRIA scores were 1.4 and 1.2, respectively. Percent time in therapeutic range of international normalized ratio was 45.8%. Thirty patients (9.9%) had cardiac death and 41 had some type of bleeding due to warfarin. By univariate analysis, there was statistical significance between cardiac death and permanent AF, blood pressure, systolic dysfunction, R2CHADS2, CCS, EHRA and HAS-BLED. There was no association with valvular AF. By multivariate analysis, systemic arterial and pulmonary artery pressures, classification CCS and systolic dysfunction showed statistical significance. Conclusions: There was no association between cardiac death and valvular AF. Independent predictors of cardiac death were low measures of blood pressure, higher score CCS classification and the presence of systolic ventricular dysfunction.

Resumo Fundamento: A fibrilação atrial (FA) é uma arritmia comum, com risco de embolia sistêmica e morte. Apresenta etiologia reumática em até 32% dos países em desenvolvimento, cujos dados de anticoagulação e evolução são escassos. Objetivos: Verificar as variáveis preditoras de morte cardíaca (MC) conforme o perfil clínico, os escores de tromboembolismo e de sangramento dos pacientes com FA de uma única instituição universitária, com alta prevalência de cardiopatia reumática. Métodos: Foram estudados 302 pts com FA, média de idade 58,1 anos; 161 mulheres; 96 pts com etiologia reumática. Os pts foram submetidos à avaliação clínica e laboratorial, ao cálculo dos escores de risco e ao seguimento clínico médio de 12,8 meses. Resultados: 174 pts estavam em uso de varfarina. As médias dos escores HAS-BLED e ATRIA foram de 1,4 e de 1,2, respectivamente. O cálculo da fração dos valores da razão normalizada internacional dentro do intervalo terapêutico foi de 45,8%. Houve MC em 30 pts (9,9%) e 41 apresentaram algum tipo de hemorragia em decorrência do uso de varfarina. Pela análise univariada, houve significância estatística entre MC e FA permanente, pressões arteriais, disfunção sistólica, R2CHADS2, CCS, EHRA e HAS-BLED. Não houve associação com FA valvar. Por meio da análise multivariada, a pressão arterial sistêmica e da artéria pulmonar, a classificação CCS e a disfunção sistólica apresentavam significância estatística. Conclusões: Não houve associação entre MC e FA valvar. Os preditores independentes de MC foram medidas baixas de pressão arterial, escores mais elevados da classificação CCS e a presença de disfunção ventricular sistólica.