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Titel:

Fibrinolysis for patients with intermediate-risk pulmonary embolism.

Dokumenttyp:
Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Article
Autor(en):
Meyer, Guy; Vicaut, Eric; Danays, Thierry; Agnelli, Giancarlo; Becattini, Cecilia; Beyer-Westendorf, Jan; Bluhmki, Erich; Bouvaist, Hélène; 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, A...     »
Abstract:
The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial.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.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).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.).
Zeitschriftentitel:
N Engl J Med
Jahr:
2014
Band / Volume:
370
Heft / Issue:
15
Seitenangaben Beitrag:
1402-11
Sprache:
eng
Volltext / DOI:
doi:10.1056/NEJMoa1302097
PubMed:
http://view.ncbi.nlm.nih.gov/pubmed/24716681
Print-ISSN:
0028-4793
TUM Einrichtung:
I. Medizinische Klinik und Poliklinik (Kardiologie)
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