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Comment on “Fibrinolysis for patients with intermediate-risk pulmonary embolism”
Comentário a «Fibrinólise nos doentes com embolia pulmonar de risco intermédio»
Maria da Graça Castro
Membro do Corpo Redatorial da Revista Portuguesa de Cardiologia
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"apellidos" => "Nunes" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "en" => array:9 [ "pii" => "S0870255114002327" "doi" => "10.1016/j.repc.2014.09.004" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0870255114002327?idApp=UINPBA00004E" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2174204914002359?idApp=UINPBA00004E" "url" => "/21742049/0000003300000010/v1_201411060106/S2174204914002359/v1_201411060106/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Recommended Article of the Month</span>" "titulo" => "Comment on “Fibrinolysis for patients with intermediate-risk pulmonary embolism”" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "663" "paginaFinal" => "664" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Maria da Graça Castro" "autores" => array:1 [ 0 => array:3 [ "nombre" => "Maria da Graça" "apellidos" => "Castro" "email" => array:1 [ 0 => "castro2406@gmail.com" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Membro do Corpo Redatorial da Revista Portuguesa de Cardiologia" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "Comentário a «Fibrinólise nos doentes com embolia pulmonar de risco intermédio»" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall"><elsevierMultimedia ident="tb0005"></elsevierMultimedia></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Abstract</span><p id="par0020" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Background</span>: The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial.</p><p id="par0025" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Methods</span>: In a randomized, double-blind trial, we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism. Eligible patients had right ventricular dysfunction on echocardiography or computed tomography, as well as myocardial injury as indicated by a positive test for cardiac troponin <span class="elsevierStyleSmallCaps">I</span> or troponin T. The primary outcome was death or hemodynamic decompensation (or collapse) within 7 days after randomization. The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization.</p><p id="par0030" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Results</span>: Of 1006 patients who underwent randomization, 1005 were included in the intention-to-treat analysis. Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; p<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.02). Between randomization and day 7, a total of 6 patients (1.2%) in the tenecteplase group and 9 (1.8%) in the placebo group died (p<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001). Stroke occurred in 12 patients (2.4%) in the tenecteplase group and was hemorrhagic in 10 patients; 1 patient (0.2%) in the placebo group had a stroke, which was hemorrhagic (p<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.003). By day 30, a total of 12 patients (2.4%) in the tenecteplase group and 16 patients (3.2%) in the placebo group had died (p<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.42).</p><p id="par0035" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Conclusions</span>: In patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of <span class="elsevierStyleItalic">major</span> hemorrhage and stroke. (Funded by the Programme Hospitalier de Recherche Clinique in France and others; PEITHO EudraCT number, 2006-005328-18; ClinicalTrials.gov number, NCT00639743.) The New England Journal of Medicine Downloaded from nejm.org at UNIVERSITEIT MAASTRICHT on June 14, 2014. For personal use only. No other uses without permission.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Comentário</span><p id="par0040" class="elsevierStylePara elsevierViewall">A embolia pulmonar (EP) representa a terceira síndrome cardiovascular aguda mais frequente depois do acidente vascular cerebral (AVC) e do acidente coronário agudo. Continua a ser uma importante causa de morbilidade e mortalidade apesar de ser a mais evitável de todas as causas de morte intra-hospitalar se forem corretamente implementadas as medidas de prevenção.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Quando entregue à sua história natural, a mortalidade pode ser alta e a taxa de recorrência elevada.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Mas a EP é uma entidade heterogénea, com níveis de gravidade muito variáveis, que vão desde formas com pior prognóstico que cursam com colapso hemodinâmico, até às formas de prognóstico muito favorável com estabilidade clínica e hemodinâmica, função ventricular direita normal e sem marcadores de lesão miocárdica.</p><p id="par0055" class="elsevierStylePara elsevierViewall">A estratificação do risco de morte precoce é crucial para definir a estratégia diagnóstica e terapêutica.</p><p id="par0060" class="elsevierStylePara elsevierViewall">Está bem estabelecido o valor terapêutico da fibrinólise nos doentes com EP de alto risco<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>.</p><p id="par0065" class="elsevierStylePara elsevierViewall">O estudo <span class="elsevierStyleItalic">Pulmonary Embolism Thrombolsysis Study</span> (PEITHO), apresentado no artigo aqui recomendado<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a>, foi desenhado para clarificar o papel da terapêutica fibrinolítica em doentes com EP de risco intermédio apresentando simultaneamente disfunção ventricular direita e elevação enzimática. Mais de 1.000 doentes oriundos de 76 centros em 13 países diferentes foram incluídos e randomizados de forma cega para receber tratamento fibrinolítico ou placebo, associado em ambos os grupos a heparina não fracionada.</p><p id="par0070" class="elsevierStylePara elsevierViewall">A fibrinólise mostrou eficácia na redução de eventos clínicos (morte e deterioração hemodinâmica) aos 30 dias, atingindo maior significado estatístico na redução do risco de deterioração hemodinâmica. A contrapartida foi o aumento de eventos hemorrágicos major extracranianos e de AVC hemorrágico, com maior incidência no grupo dos mais idosos. No global beneficiaram mais com a terapêutica fibrinolítica os doentes de idade inferior a 75 anos.</p><p id="par0075" class="elsevierStylePara elsevierViewall">Mesmo em doentes normotensos e clinicamente estáveis têm sido apontados vários fatores associados a pior prognóstico e maior risco de morte como é o caso da doença pulmonar crónica, insuficiência cardíaca, idade superior a 80 anos e disfunção ventricular direita<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3,4</span></a>.</p><p id="par0080" class="elsevierStylePara elsevierViewall">Por outro lado existe alguma evidência de que o benefício da fibrinólise se estende para além da fase aguda reduzindo a incidência de tromboembolia pulmonar crónica<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a>.</p><p id="par0085" class="elsevierStylePara elsevierViewall">Outras interrogações ainda em aberto e também sublinhadas neste estudo prendem-se com a necessidade de estudar novos esquemas de terapêutica fibrinolítica com redução das doses em populações de maior risco e o recurso a novas terapêuticas de intervenção.</p><p id="par0090" class="elsevierStylePara elsevierViewall">O primeiro grande mérito deste trabalho reside no facto de ser um estudo multicêntrico de iniciativa do investigador desenhado para dar resposta a uma questão clínica muito premente. O conceito de que faz sentido estratificar o risco nos doentes com EP sai claramente reforçado deste estudo e mostra simultaneamente a necessidade de refinar esta estratificação particularmente no grupo de doentes com EP de risco intermédio.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflicts of interest</span><p id="par0095" class="elsevierStylePara elsevierViewall">Os autores declaram não haver conflito de interesses.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Abstract" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Comentário" ] 2 => array:2 [ "identificador" => "sec0015" "titulo" => "Conflicts of interest" ] 3 => array:1 [ "titulo" => "Bibliografia" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "multimedia" => array:1 [ 0 => array:5 [ "identificador" => "tb0005" "tipo" => "MULTIMEDIATEXTO" "mostrarFloat" => false "mostrarDisplay" => true "texto" => array:1 [ "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0010" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Fibrinolysis for patients with intermediate-risk pulmonary embolism</span>. Guy Meyer, Eric Vicaut, Thierry Danays,Giancarlo Agnelli, Cecilia Becattini, Jan Beyer-Westendorf, Erich Bluhmki, Helene Bouvaist, Benjamin Brenner, Francis Couturaud, Claudia Dellas, Klaus Empen, Ana Franca, Nazzareno Galiè, Annette Geibel, Samuel Z. Goldhaber, David Jimenez, Matija Kozak, Christian Kupatt, Nils Kucher, Irene M. Lang, Mareike Lankeit, Nicolas Meneveau, Gerard Pacouret, Massimiliano Palazzini, Antoniu Petris, Piotr Pruszczyk, Matteo Rugolotto, Aldo Salvi, Sebastian Schellong, Mustapha Sebbane, Bozena Sobkowicz, Branislav S. Stefanovic,</p><p id="par0015" class="elsevierStylePara elsevierViewall">Holger Thiele, Adam Torbicki, Franck Verschuren, and Stavros <span class="elsevierStyleSmallCaps">V</span>. Konstantinides, M.D., for the PEITHO Investigators. 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| 2024 March | 27 | 16 | 43 |
| 2024 February | 32 | 21 | 53 |
| 2024 January | 21 | 22 | 43 |
| 2023 December | 21 | 18 | 39 |
| 2023 November | 24 | 29 | 53 |
| 2023 October | 18 | 18 | 36 |
| 2023 September | 21 | 22 | 43 |
| 2023 August | 15 | 13 | 28 |
| 2023 July | 25 | 19 | 44 |
| 2023 June | 27 | 15 | 42 |
| 2023 May | 30 | 23 | 53 |
| 2023 April | 23 | 6 | 29 |
| 2023 March | 30 | 19 | 49 |
| 2023 February | 35 | 23 | 58 |
| 2023 January | 20 | 22 | 42 |
| 2022 December | 30 | 16 | 46 |
| 2022 November | 41 | 23 | 64 |
| 2022 October | 25 | 21 | 46 |
| 2022 September | 29 | 38 | 67 |
| 2022 August | 33 | 31 | 64 |
| 2022 July | 36 | 39 | 75 |
| 2022 June | 17 | 23 | 40 |
| 2022 May | 14 | 24 | 38 |
| 2022 April | 31 | 42 | 73 |
| 2022 March | 24 | 50 | 74 |
| 2022 February | 23 | 32 | 55 |
| 2022 January | 21 | 25 | 46 |
| 2021 December | 24 | 35 | 59 |
| 2021 November | 30 | 29 | 59 |
| 2021 October | 33 | 41 | 74 |
| 2021 September | 19 | 30 | 49 |
| 2021 August | 22 | 24 | 46 |
| 2021 July | 15 | 21 | 36 |
| 2021 June | 17 | 12 | 29 |
| 2021 May | 26 | 30 | 56 |
| 2021 April | 32 | 21 | 53 |
| 2021 March | 39 | 12 | 51 |
| 2021 February | 44 | 19 | 63 |
| 2021 January | 17 | 11 | 28 |
| 2020 December | 30 | 12 | 42 |
| 2020 November | 24 | 8 | 32 |
| 2020 October | 21 | 3 | 24 |
| 2020 September | 33 | 7 | 40 |
| 2020 August | 28 | 5 | 33 |
| 2020 July | 38 | 2 | 40 |
| 2020 June | 27 | 10 | 37 |
| 2020 May | 29 | 2 | 31 |
| 2020 April | 36 | 13 | 49 |
| 2020 March | 34 | 4 | 38 |
| 2020 February | 37 | 17 | 54 |
| 2020 January | 31 | 7 | 38 |
| 2019 December | 27 | 7 | 34 |
| 2019 November | 38 | 5 | 43 |
| 2019 October | 26 | 7 | 33 |
| 2019 September | 16 | 5 | 21 |
| 2019 August | 33 | 4 | 37 |
| 2019 July | 32 | 10 | 42 |
| 2019 June | 23 | 5 | 28 |
| 2019 May | 27 | 4 | 31 |
| 2019 April | 20 | 7 | 27 |
| 2019 March | 21 | 12 | 33 |
| 2019 February | 34 | 9 | 43 |
| 2019 January | 52 | 5 | 57 |
| 2018 December | 71 | 9 | 80 |
| 2018 November | 36 | 7 | 43 |
| 2018 October | 76 | 12 | 88 |
| 2018 September | 33 | 16 | 49 |
| 2018 August | 34 | 5 | 39 |
| 2018 July | 23 | 3 | 26 |
| 2018 June | 27 | 3 | 30 |
| 2018 May | 39 | 11 | 50 |
| 2018 April | 57 | 2 | 59 |
| 2018 March | 51 | 10 | 61 |
| 2018 February | 61 | 6 | 67 |
| 2018 January | 50 | 12 | 62 |
| 2017 December | 78 | 6 | 84 |
| 2017 November | 46 | 8 | 54 |
| 2017 October | 36 | 16 | 52 |
| 2017 September | 45 | 9 | 54 |
| 2017 August | 36 | 13 | 49 |
| 2017 July | 22 | 12 | 34 |
| 2017 June | 42 | 9 | 51 |
| 2017 May | 18 | 2 | 20 |
| 2017 April | 22 | 3 | 25 |
| 2017 March | 23 | 49 | 72 |
| 2017 February | 24 | 1 | 25 |
| 2017 January | 24 | 0 | 24 |
| 2016 December | 29 | 5 | 34 |
| 2016 November | 21 | 1 | 22 |
| 2016 October | 25 | 8 | 33 |
| 2016 September | 29 | 3 | 32 |
| 2016 August | 11 | 1 | 12 |
| 2016 July | 11 | 3 | 14 |
| 2016 June | 16 | 4 | 20 |
| 2016 May | 17 | 5 | 22 |
| 2016 April | 23 | 2 | 25 |
| 2016 March | 37 | 21 | 58 |
| 2016 February | 65 | 28 | 93 |
| 2016 January | 49 | 22 | 71 |
| 2015 December | 50 | 19 | 69 |
| 2015 November | 50 | 17 | 67 |
| 2015 October | 67 | 17 | 84 |
| 2015 September | 50 | 13 | 63 |
| 2015 August | 29 | 7 | 36 |
| 2015 July | 28 | 5 | 33 |
| 2015 June | 26 | 1 | 27 |
| 2015 May | 36 | 9 | 45 |
| 2015 April | 36 | 15 | 51 |
| 2015 March | 33 | 5 | 38 |
| 2015 February | 28 | 8 | 36 |
| 2015 January | 47 | 12 | 59 |
| 2014 December | 54 | 22 | 76 |
| 2014 November | 102 | 32 | 134 |
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