Fibrinolysis for patients with intermediate-risk pulmonary embolism.
In: ISSN: 0028-4793, 2014
academicJournal
Zugriff:
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.).
| Titel: |
Fibrinolysis for patients with intermediate-risk pulmonary embolism.
|
|---|---|
| Autor/in / Beteiligte Person: | 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 ; Hôpital Européen Georges Pompidou APHP (HEGP) ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO) ; Thrombose, GIRC ; Service de Statistiques ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand-Widal ; BOEHRINGER, INGELHEIM ; Ingelheim, Boehringer ; Internal and Cardiovascular Medicine - Stroke Unit (PERUGIA - ICM-SU) ; Università degli Studi di Perugia = University of Perugia (UNIPG) ; Carl Gustav Carus University (DRESDEN - CGCU) ; Technische Universität Dresden = Dresden University of Technology (TU Dresden) ; Service de Cardiologie ; Grenoble, CHU ; Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO) ; Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM) ; Université de Brest (UBO)-Université de Brest (UBO) ; Centre d'Investigation Clinique (CIC - Brest) ; Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM) ; Département de Médecine Interne et Pneumologie Brest (DMIP - Brest) ; Centre Hospitalier Régional Universitaire de Brest (CHRU Brest) ; Department of Cardiology ; University of Freiburg Freiburg ; Cardiovascular Division (SZG) ; Brigham and Women's Hospital Boston ; Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920) (PCVP / CARDIO) ; Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC) ; Université Bourgogne Franche-Comté COMUE (UBFC)-Université Bourgogne Franche-Comté COMUE (UBFC) ; Service de Cardiologie A (TOURS - Cardiologie A) ; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) ; Dresden-Friedrichstadt Hospital (DRESDEN-FRIEDRICHSTADT HOSPITAL) ; Hospital, Dresden-Friedrichstadt ; Département de Médecine d'Urgence ; Lapeyronie, Hôpital ; University of Cologne ; Emergency Department (FV - ED) ; Saint Luc University Hospital |
| Link: | |
| Zeitschrift: | ISSN: 0028-4793, 2014 |
| Veröffentlichung: | HAL CCSD ; Massachusetts Medical Society, 2014 |
| Medientyp: | academicJournal |
| DOI: | 10.1056/NEJMoa1302097 |
| Schlagwort: |
|
| Sonstiges: |
|