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    "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>&#58; The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Methods</span>&#58; In a randomized&#44; double-blind trial&#44; we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism&#46; Eligible patients had right ventricular dysfunction on echocardiography or computed tomography&#44; as well as myocardial injury as indicated by a positive test for cardiac troponin <span class="elsevierStyleSmallCaps">I</span> or troponin T&#46; The primary outcome was death or hemodynamic decompensation &#40;or collapse&#41; within 7 days after randomization&#46; The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Results</span>&#58; Of 1006 patients who underwent randomization&#44; 1005 were included in the intention-to-treat analysis&#46; Death or hemodynamic decompensation occurred in 13 of 506 patients &#40;2&#46;6&#37;&#41; in the tenecteplase group as compared with 28 of 499 &#40;5&#46;6&#37;&#41; in the placebo group &#40;odds ratio&#44; 0&#46;44&#59; 95&#37; confidence interval&#44; 0&#46;23 to 0&#46;87&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;02&#41;&#46; Between randomization and day 7&#44; a total of 6 patients &#40;1&#46;2&#37;&#41; in the tenecteplase group and 9 &#40;1&#46;8&#37;&#41; in the placebo group died &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;42&#41;&#46; Extracranial bleeding occurred in 32 patients &#40;6&#46;3&#37;&#41; in the tenecteplase group and 6 patients &#40;1&#46;2&#37;&#41; in the placebo group &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46; Stroke occurred in 12 patients &#40;2&#46;4&#37;&#41; in the tenecteplase group and was hemorrhagic in 10 patients&#59; 1 patient &#40;0&#46;2&#37;&#41; in the placebo group had a stroke&#44; which was hemorrhagic &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;003&#41;&#46; By day 30&#44; a total of 12 patients &#40;2&#46;4&#37;&#41; in the tenecteplase group and 16 patients &#40;3&#46;2&#37;&#41; in the placebo group had died &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;42&#41;&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Conclusions</span>&#58; In patients with intermediate-risk pulmonary embolism&#44; fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of <span class="elsevierStyleItalic">major</span> hemorrhage and stroke&#46; &#40;Funded by the Programme Hospitalier de Recherche Clinique in France and others&#59; PEITHO EudraCT number&#44; 2006-005328-18&#59; ClinicalTrials&#46;gov number&#44; NCT00639743&#46;&#41; The New England Journal of Medicine Downloaded from nejm&#46;org at UNIVERSITEIT MAASTRICHT on June 14&#44; 2014&#46; For personal use only&#46; No other uses without permission&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Coment&#225;rio</span><p id="par0040" class="elsevierStylePara elsevierViewall">A embolia pulmonar &#40;EP&#41; representa a terceira s&#237;ndrome cardiovascular aguda mais frequente depois do acidente vascular cerebral &#40;AVC&#41; e do acidente coron&#225;rio agudo&#46; Continua a ser uma importante causa de morbilidade e mortalidade apesar de ser a mais evit&#225;vel de todas as causas de morte intra-hospitalar se forem corretamente implementadas as medidas de preven&#231;&#227;o&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Quando entregue &#224; sua hist&#243;ria natural&#44; a mortalidade pode ser alta e a taxa de recorr&#234;ncia elevada&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Mas a EP &#233; uma entidade heterog&#233;nea&#44; com n&#237;veis de gravidade muito vari&#225;veis&#44; que v&#227;o desde formas com pior progn&#243;stico que cursam com colapso hemodin&#226;mico&#44; at&#233; &#224;s formas de progn&#243;stico muito favor&#225;vel com estabilidade cl&#237;nica e hemodin&#226;mica&#44; fun&#231;&#227;o ventricular direita normal e sem marcadores de les&#227;o mioc&#225;rdica&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">A estratifica&#231;&#227;o do risco de morte precoce &#233; crucial para definir a estrat&#233;gia diagn&#243;stica e terap&#234;utica&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Est&#225; bem estabelecido o valor terap&#234;utico da fibrin&#243;lise nos doentes com EP de alto risco<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">O estudo <span class="elsevierStyleItalic">Pulmonary Embolism Thrombolsysis Study</span> &#40;PEITHO&#41;&#44; apresentado no artigo aqui recomendado<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a>&#44; foi desenhado para clarificar o papel da terap&#234;utica fibrinol&#237;tica em doentes com EP de risco interm&#233;dio apresentando simultaneamente disfun&#231;&#227;o ventricular direita e eleva&#231;&#227;o enzim&#225;tica&#46; Mais de 1&#46;000 doentes oriundos de 76 centros em 13 pa&#237;ses diferentes foram inclu&#237;dos e randomizados de forma cega para receber tratamento fibrinol&#237;tico ou placebo&#44; associado em ambos os grupos a heparina n&#227;o fracionada&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">A fibrin&#243;lise mostrou efic&#225;cia na redu&#231;&#227;o de eventos cl&#237;nicos &#40;morte e deteriora&#231;&#227;o hemodin&#226;mica&#41; aos 30 dias&#44; atingindo maior significado estat&#237;stico na redu&#231;&#227;o do risco de deteriora&#231;&#227;o hemodin&#226;mica&#46; A contrapartida foi o aumento de eventos hemorr&#225;gicos major extracranianos e de AVC hemorr&#225;gico&#44; 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Vol. 33. Issue 10.
Pages 663-664 (October 2014)
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Vol. 33. Issue 10.
Pages 663-664 (October 2014)
Recommended Article of the Month
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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»
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Maria da Graça Castro
Membro do Corpo Redatorial da Revista Portuguesa de Cardiologia
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Fibrinolysis for patients with intermediate-risk pulmonary embolism. 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,

Holger Thiele, Adam Torbicki, Franck Verschuren, and Stavros V. Konstantinides, M.D., for the PEITHO Investigators. N Engl J Med. 2014;370:1402-11.

Abstract

Background: The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial.

Methods: 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 I 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.

Results: 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=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=0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (p<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=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=0.42).

Conclusions: In patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major 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.

Comentário

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.

Quando entregue à sua história natural, a mortalidade pode ser alta e a taxa de recorrência elevada.

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.

A estratificação do risco de morte precoce é crucial para definir a estratégia diagnóstica e terapêutica.

Está bem estabelecido o valor terapêutico da fibrinólise nos doentes com EP de alto risco1.

O estudo Pulmonary Embolism Thrombolsysis Study (PEITHO), apresentado no artigo aqui recomendado2, 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.

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.

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 direita3,4.

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 crónica5.

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.

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.

Conflicts of interest

Os autores declaram não haver conflito de interesses.

Bibliografia
[1]
A. Torbicki, A. Perrier, S. Konstantinides, et al.
Guidelines on the diagnosis and management of acute pulmonary embolism.
Eur Heart J, 29 (2008), pp. 2276-2315
[2]
G. Meyer, E. Vicaut, T. Danays, et al.
Fibrinolysis for patients with intermediate risk pulmonary embolism.
N Engl J Med., 370 (2014), pp. 1402-1411
[3]
D. Jimenez, D. Aujesky, Ç. Moores, et al.
Simplification of the pulmonary embolism severity index for prognostication in patients with acute symptomatic pulmonary embolism.
Arch Inter Med, 170 (2010), pp. 1383-1389
[4]
R. Baptista, I. Santiago, E. Jorge, et al.
One-shot diagnostic and prognostic assessment in intermediate to high-risk acute pulmonary embolism: The role of multidetector computed tomography.
Rev Port Cardiol., 32 (2013), pp. 7-13
[5]
M.R. Jaff, M.S. McMurty, S.L. Archer, et al.
Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association.
Circulation., 123 (2011), pp. 1788-1830
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