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Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism

Open access
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.·2014·New England Journal of Medicine

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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Metadata

Authors
Meyer, G., Vicaut, E., Danays, T., Agnelli, G., Becattini, C., Beyer-Westendorf, J., Bluhmki, E., Bouvaist, H., Brenner, B., Couturaud, F., Dellas, C., Empen, K., Franca, A., Galiè, N., Geibel, A., Goldhaber, S. Z., Jimenez, D., Kozak, M., Kupatt, C., Kucher, N., Lang, I. M., Lankeit, M., Meneveau, N., Pacouret, G., Palazzini, M., Petris, A., Pruszczyk, P., Rugolotto, M., Salvi, A., Schellong, S., Sebbane, M., Sobkowicz, B., Stefanovic, B. S., Thiele, H., Torbicki, A., Verschuren, F., & Konstantinides, S. V.
Venue
New England Journal of Medicine
Published
2014-04-10
Volume
370
Issue
15
Pages
1402-1411
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2159007980
Cited by
1,706
References
2
FWCI
97.86
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism. https://app.cochat.ai/papers/10.1056/nejmoa1302097
The paper
Meyer, G., Vicaut, E., Danays, T., Agnelli, G., Becattini, C., Beyer-Westendorf, J., Bluhmki, E., Bouvaist, H., Brenner, B., Couturaud, F., Dellas, C., Empen, K., Franca, A., Galiè, N., Geibel, A., Goldhaber, S. Z., Jimenez, D., Kozak, M., Kupatt, C., . . . Konstantinides, S. V. (2014). Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1302097

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.