IMPORTANCE: Active search for pulmonary embolism (PE) may improve outcomes in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD). OBJECTIVE: To compare usual care ...plus an active strategy for diagnosing PE with usual care alone in patients hospitalized for COPD exacerbation. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted across 18 hospitals in Spain. A total of 746 patients were randomized from September 2014 to July 2020 (final follow-up was November 2020). INTERVENTIONS: Usual care plus an active strategy for diagnosing PE (D-dimer testing and, if positive, computed tomography pulmonary angiogram) (n = 370) vs usual care (n = 367). MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of nonfatal symptomatic venous thromboembolism (VTE), readmission for COPD, or death within 90 days after randomization. There were 4 secondary outcomes, including nonfatal new or recurrent VTE, readmission for COPD, and death from any cause within 90 days. Adverse events were also collected. RESULTS: Among the 746 patients who were randomized, 737 (98.8%) completed the trial (mean age, 70 years; 195 26% women). The primary outcome occurred in 110 patients (29.7%) in the intervention group and 107 patients (29.2%) in the control group (absolute risk difference, 0.5% 95% CI, −6.2% to 7.3%; relative risk, 1.02 95% CI, 0.82-1.28; P = .86). Nonfatal new or recurrent VTE was not significantly different in the 2 groups (0.5% vs 2.5%; risk difference, −2.0% 95% CI, −4.3% to 0.1%). By day 90, a total of 94 patients (25.4%) in the intervention group and 84 (22.9%) in the control group had been readmitted for exacerbation of COPD (risk difference, 2.5% 95% CI, −3.9% to 8.9%). Death from any cause occurred in 23 patients (6.2%) in the intervention group and 29 (7.9%) in the control group (risk difference, −1.7% 95% CI, −5.7% to 2.3%). Major bleeding occurred in 3 patients (0.8%) in the intervention group and 3 patients (0.8%) in the control group (risk difference, 0% 95% CI, −1.9% to 1.8%; P = .99). CONCLUSIONS AND RELEVANCE: Among patients hospitalized for an exacerbation of COPD, the addition of an active strategy for the diagnosis of PE to usual care, compared with usual care alone, did not significantly improve a composite health outcome. The study may not have had adequate power to assess individual components of the composite outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02238639
Methods RE-VERSE AD is an ongoing multinational, single cohort study investigating the safety and efficacy of 5 g idarucizumab to reverse dabigatran in patients with life-threatening or uncontrolled ...bleeding (Group A) or who require an emergency procedure (Group B).
Diagnosing pulmonary embolism in suspected patients is notoriously difficult as signs and symptoms are non-specific. Different diagnostic strategies have been developed, usually combining clinical ...probability assessment with D-dimer testing. However, their predictive performance differs across different healthcare settings, patient subgroups, and clinical presentation, which are currently not accounted for in the available diagnostic approaches.
This is a protocol for a large diagnostic individual patient data meta-analysis (IPDMA) of currently available diagnostic studies in the field of pulmonary embolism. We searched MEDLINE (search date January 1, 1995, till August 25, 2016) to retrieve all primary diagnostic studies that had evaluated diagnostic strategies for pulmonary embolism. Two authors independently screened titles, abstracts, and subsequently full-text articles for eligibility from 3145 individual studies. A total of 40 studies were deemed eligible for inclusion into our IPDMA set, and principal investigators from these studies were invited to participate in a meeting at the 2017 conference from the International Society on Thrombosis and Haemostasis. All authors agreed on data sharing and participation into this project. The process of data collection of available datasets as well as potential identification of additional new datasets based upon personal contacts and an updated search will be finalized early 2018. The aim is to evaluate diagnostic strategies across three research domains: (i) the optimal diagnostic approach for different healthcare settings, (ii) influence of comorbidity on the predictive performance of each diagnostic strategy, and (iii) optimize and tailor the efficiency and safety of ruling out PE across a broad spectrum of patients with a new, patient-tailored clinical decision model that combines clinical items with quantitative D-dimer testing.
This pre-planned individual patient data meta-analysis aims to contribute in resolving remaining diagnostic challenges of time-efficient diagnosis of pulmonary embolism by tailoring available diagnostic strategies for different healthcare settings and comorbidity.
Prospero trial registration: ID 89366.
Abstract Comité de la ESC para la elaboración de Guías de Práctica Clínica (CPG): José Luis Zamorano (Presidente) (España), Stephan Achenbach (Alemania), Helmut Baumgartner (Alemania), Jeroen J. Bax ...(Países Bajos), Héctor Bueno (España), Veronica Dean (Francia), Christi Deaton (Reino Unido), Çetin Erol (Turquía), Robert Fagard (Bélgica), Roberto Ferrari (Italia), David Hasdai (Israel), Arno Hoes (Países Bajos), Paulus Kirchhof (Alemania/Reino Unido), Juhani Knuuti (Finlandia), Philippe Kolh (Bélgica), Patrizio Lancellotti (Bélgica), Ales Linhart (República Checa), Petros Nihoyannopoulos (Reino Unido), Massimo F. Piepoli (Italia), Piotr Ponikowski (Polonia), Per Anton Sirnes (Noruega), Juan Luis Tamargo (España), Michal Tendera (Polonia), Adam Torbicki (Polonia), William Wijns (Bélgica), Stephan Windecker (Suiza) Revisores del documento: Çetin Erol (Coordinador de revisión del CPG) (Turquía), David Jiménez (Coordinador de revisión) (España), Walter Ageno (Italia), Stefan Agewall (Noruega), Riccardo Asteggiano (Italia), Rupert Bauersachs (Alemania), Cecilia Becattini (Italia), Henri Bounameaux (Suiza), Harry R. Büller (Países Bajos), Constantinos H. Davos (Grecia), Christi Deaton (Reino Unido), Geert-Jan Geersing (Países Bajos), Miguel Ángel Gómez Sánchez (España), Jeroen Hendriks (Países Bajos), Arno Hoes (Países Bajos), Mustafa Kilickap (Turquía), Viacheslav Mareev (Rusia), Manuel Monreal (España), Joao Morais (Portugal), Petros Nihoyannopoulos (Reino Unido), Bogdan A. Popescu (Rumanía), Olivier Sánchez** (Francia), Alex C . Spyropoulos (Estados Unidos) Otras entidades ESC que han participado en el desarrollo de este documento: Asociaciones: Acute Cardiovascular Care Association (ACCA), European Association for Cardiovascular Prevention & Rehabilitation (EACPR), European Association of Cardiovascular Imaging (EACVI), Heart Failure Association (HFA). Consejos: Council on Cardiovascular Nursing and Allied Professions (CCNAP), Council for Cardiology Practice (CCP), Council on Cardiovascular Primary Care (CCPC). Grupos de Trabajo: Cardiovascular Pharmacology and Drug Therapy, Nuclear Cardiology and Cardiac Computed Tomography, Peripheral Circulation, Pulmonary Circulation and Right Ventricular Function, Thrombosis. Descargo de responsabilidad: La guía de práctica clínica de la ESC representa la opinión de la ESC y se ha elaborado tras una cuidadosa consideración del conocimiento científico y médico y de la evidencia disponible en el momento de su publicación. La ESC no se hace responsable en caso de contradicción, discrepancia o ambigüedad entre las guías de la ESC y cualesquiera otras recomendaciones o directrices oficiales publicadas por las autoridades de salud pública competentes, en particular en relación con el buen uso de estrategias de salud o terapéuticas. Se anima a los profesionales de la salud a tomar en plena consideración las guías de la ESC al ejercer su juicio clínico, así como al determinar e implementar estrategias médicas preventivas, diagnósticas o terapéuticas; sin embargo, las guías de la ESC no invalidan en modo alguno la responsabilidad individual de los profesionales de la salud en la toma de decisiones apropiadas y precisas adecuadas al estado de salud de cada paciente y consultando con ese paciente y, cuando resulte apropiado o necesario, sus cuidadores. Las guías de la ESC tampoco eximen a los profesionales de la salud de tomar en consideración plena y cuidadosa las recomendaciones o directrices oficiales actualizadas y relevantes publicadas por las autoridades competentes de salud pública, con objeto de tratar el caso de cada paciente a la luz de los datos científicamente aceptados conforme a sus obligaciones éticas y profesionales respectivas. Es también responsabilidad del profesional de la salud verificar las normas y los reglamentos aplicables en relación con fármacos y dispositivos médicos en el momento de la prescripción. Revisores del documento de las Sociedades Cardiacas Nacionales: se listan en el anexo 1 al final del texto. Los documentos de declaración de conflictos de intereses proporcionados por los expertos implicados en el desarrollo de esta guía están disponibles en la página web de la ESC: www.escardio.org/guidelines
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