Perspectivas clínicas del manejo de la hemorragia en el paciente tratado con anticoagulante oral: estudio DECOVER / Clinical perspectives on the management of bleeding in patients on oral anticoagulants: the DECOVER Study (DElphi Consensus on oral COagulation and therapy action reVERsal)

Objetivo: Evaluar el grado de acuerdo entre hematólogos y urgenciólogos respecto a las mejores prácticas para el manejo de hemorragias y la reversión de la anticoagulación oral. Método: Estudio Delphi multicéntrico español con médicos expertos en anticoagulación y manejo de hemorragias. Se realizaron dos rondas de preguntas entre abril y septiembre de 2015. Se obtenía consenso cuando el 75% o más de los panelistas puntuaban en el mismo tercil. Resultados: Se encuestó a 15 hematólogos y 17 urgenciólogos de 14 comunidades autónomas. La hemodiálisis y la administración de concentrados de complejo protrombínico (CCP) activado fueron tratamientos consensuados para antagonizar una hemorragia relevante/mayor en pacientes tratados con dabigatrán. Para rivaroxabán y apixabán solo se consideró el CCP. El panel no valoró ningún CCP como eficaz y seguro a la vez. Los tiempos de tromboplastina parcial activado, trombina, ecarina y de trombina diluido se indicaron para pacientes tratados con dabigatrán y la actividad anti-Xa específica para los tratados con rivaroxabán y apixabán cuando presentan una hemorragia. Disponer de un antídoto específico para el tratamiento de los anticoagulantes orales de acción directa (ACOD) sería útil en caso de hemorragia grave (97%) y supondría un cambio sustancial en el algoritmo de tratamiento actual (97%). Conclusiones: Los resultados estuvieron en general alineados con las guías de práctica clínica, pero mostraron que existen áreas de mejora en la unificación de criterios sobre el manejo de los pacientes con hemorragias, y destacan la necesidad de disponer de antídotos específicos para ACOD (AU)

Objective: To evaluate the level of agreement between hematologists and emergency medicine physicians regarding the best clinical practices for managing bleeding and anticoagulant reversal. Methods: Nationwide Spanish multicenter Delphi method study with a panel of experts on anticoagulation and the management of bleeding. Two survey rounds were carried out between April and September 2015. Consensus was reached when more than 75% of the panelists scored items in the same tertile. Results: Fifteen hematologists and 17 emergency medicine specialists from 14 Spanish autonomous communities participated. Consensus was reached on the use of both hemodialysis and an activated prothrombin complex concentrate (PCC) to antagonize significant/major bleeding in patients taking dabigatran. Use of an activated PCC was considered sufficient for patients on rivaroxaban or apixaban. The panel did not consider any PCC to be both effective and safe. Tests for activated partial thromboplastin, thrombin, diluted thrombin, and ecarin clotting times were considered useful in patients treated with dabigatran. A specific anti-Xa activity assay was suggested for patients who developed bleeds while treated with rivaroxaban or apixaban. Specific antidotes for direct-acting oral anticoagulants would be useful when severe bleeding occurs according to 97% of the panelists. Such antidotes would substantially change current treatment algorithms. Conclusion: The points of consensus were generally in line with clinical practice guidelines, but the Delphi process revealed that there are aspects of the clinical management of bleeding that require unified criteria. The need for specific antidotes for direct-acting oral anticoagulants was emphasized (AU)

Antídotos de los nuevos anticoagulantes orales: realidad y expectativas / Antidotes for the new oral anticoagulants: reality and expectations

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Direct oral anticoagulants in the treatment of acute venous thromboembolism: a systematic review and meta-analysis.

INTRODUCTION: Acute venous thromboembolism (VTE) is a common disease associated to significant morbidity and mortality. MATERIALS AND METHODS: We systematically reviewed and meta-analysed clinical outcomes with direct oral anticoagulants (DOAC: dabigatran, rivaroxaban, apixaban or edoxaban) for treatment of acute VTE. We used MEDLINE and CENTRAL, clinical trials registers, conference proceedings, and websites of regulatory agencies to identify randomised clinical trials of DOAC compared with conventional treatment [parenteral anticoagulant followed by a vitamin K antagonist (VKA)] for acute VTE. Two investigators independently extracted data. Relative risk of recurrent VTE, bleeding events, deaths and a net clinical endpoint (composite of recurrent VTE, major bleeding, and death) were estimated using a random effect meta-analysis (RevMan software). RESULTS: Six trials including 27,127 patients were selected. The risk of recurrent VTE was similar with the DOAC and standard treatment (relative risk 0.91, 95% confidence interval 0.79 to 1.06). The DOAC reduced the risk of major bleeding in comparison with standard treatment (0.62, 0.45 to 0.85) (absolute risk difference, -0.6%; 95% confidence interval -1.0% to -0.3%), but there was heterogeneity across trials in the relative risk of bleeding. No between treatment differences were found in the relative risk of all-cause mortality (0.98, 0.84 to 1.14). The DOAC and conventional treatment differed on the net clinical endpoint (0.85, 0.75 to 0.97). Subgroup analyses in relevant subgroups (index pulmonary embolism, heparin lead-in, age, gender, renal function, presence of cancer), as well as sensitivity analyses, were consistent with the main analysis. CONCLUSIONS: The DOAC seem as effective as, and probably safer than standard treatment of acute VTE. The relative efficacy and safety of the DOAC was consistent across a wide range of patients.

Enfermedad tromboembólica venosa: una llamada urgente a la acción / Venous thromboembolism: An urgent call for action

La trombosis venosa profunda (TVP) y su principal complicación, la embolia pulmonar (EP), afectan a miles de personas anualmente en el mundo. El diagnóstico es, en ocasiones, difícil, porque los signos y síntomas no siempre son evidentes. ¿Por qué la TVP/EP sigue siendo un problema sociosanitario si hay estrategias profilácticas eficaces? La respuesta puede estar en la infrautilización de las guías clínicas por el médico y en la escasa adherencia al tratamiento por los pacientes. Se precisan, por tanto, medidas urgentes que faciliten el conocimiento del problema por el público general, sistemas de alerta hospitalarios, implementación de las guías clínicas existentes e investigación traslacional para aplicar los conocimientos adquiridos al ámbito clínico. El papel de instituciones públicas y privadas y de los Gobiernos será, asimismo, clave para reducir la incidencia de TVP/EP, una de las principales causas de mortalidad en España (AU)

Thousands of individuals suffer from deep vein thrombosis (DVT) all over the world, and many will die from its main complication, pulmonary embolism (PE). An important problem is that the diagnose is easy to overlook because the signs and symptoms are often difficult to recognize. Why do DVT and PE remain such a serious problem, particularly given the availability of effective strategies for preventing and treating them? The answer lays primarily in the failure to consistently use evidence-based interventions in high-risk individuals and in the lack of adherence to the different prophylactic interventions. In order to impact the incidence and burden of DVT/PE and increase public awareness, implementation of electronic alerts and evidence-based approaches, and scientific translational research are required. The commitment of all levels of governments as well as public and private institutions will be crucial to reduce the incidence of DVT, a leading cause of death (AU)