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, PEITHO Investigators
Аннотация
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.).