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Fibrinolysis for patients with intermediate-risk pulmonary embolism.

Guy Meyer 1, 2 Eric Vicaut 3 Thierry Danays 4 Giancarlo Agnelli 5 Cecilia Becattini 5 Jan Beyer-Westendorf 6 Erich Bluhmki Helene Bouvaist 7 Benjamin Brenner Francis Couturaud 2, 8, 9, 10 Claudia Dellas Klaus Empen Ana Franca Nazzareno Galiè Annette Geibel 11 Samuel Z Goldhaber 12 David Jimenez Matija Kozak Christian Kupatt Nils Kucher Irene M Lang Mareike Lankeit Nicolas Meneveau 2, 13 Gerard Pacouret 2, 14 Massimiliano Palazzini Antoniu Petris Piotr Pruszczyk Matteo Rugolotto Aldo Salvi Sebastian Schellong 15 Mustapha Sebbane 16 Bozena Sobkowicz Branislav S Stefanovic Holger Thiele 17 Adam Torbicki Franck Verschuren 18 Stavros V Konstantinides
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.).
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https://hal.univ-brest.fr/hal-01045144
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Submitted on : Thursday, July 24, 2014 - 4:04:12 PM
Last modification on : Thursday, March 31, 2022 - 11:00:02 AM

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Guy Meyer, Eric Vicaut, Thierry Danays, Giancarlo Agnelli, Cecilia Becattini, et al.. Fibrinolysis for patients with intermediate-risk pulmonary embolism.. New England Journal of Medicine, Massachusetts Medical Society, 2014, 370 (15), pp.1402-11. ⟨10.1056/NEJMoa1302097⟩. ⟨hal-01045144⟩

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