Fibrinolysis for patients with intermediate-risk pulmonary embolism.

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Meyer, Guy | Vicaut, Eric | Danays, Thierry | Agnelli, Giancarlo | Becattini, Cecilia | Beyer-Westendorf, Jan | Bluhmki, Erich | Bouvaist, Helene | Brenner, Benjamin | Couturaud, Francis | Dellas, Claudia | Empen, Klaus | Franca, Ana | Galiè, Nazzareno | Geibel, Annette | Goldhaber, Samuel Z | Jimenez, David | Kozak, Matija | Kupatt, Christian | Kucher, Nils | Lang, Irene M | Lankeit, Mareike | Meneveau, Nicolas | Pacouret, Gerard | Palazzini, Massimiliano | Petris, Antoniu | Pruszczyk, Piotr | Rugolotto, Matteo | Salvi, Aldo | Schellong, Sebastian | Sebbane, Mustapha | Sobkowicz, Bozena | Stefanovic, Branislav S | Thiele, Holger | Torbicki, Adam | Verschuren, Franck | Konstantinides, Stavros V

Edité par CCSD ; Massachusetts Medical Society -

International audience. 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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