Fibrinolysis for patients with intermediate-risk pulmonary embolism.
Guy Meyer
(1, 2)
,
Eric Vicaut
(3)
,
Thierry Danays
(4)
,
Giancarlo Agnelli
(5)
,
Cecilia Becattini
(5)
,
Jan Beyer-Westendorf
(6)
,
Erich Bluhmki
,
Helene Bouvaist
(7)
,
Benjamin Brenner
,
Francis Couturaud
(2, 8, 9, 10)
,
Claudia Dellas
,
Klaus Empen
,
Ana Franca
,
Nazzareno Galiè
,
Annette Geibel
(11)
,
Samuel Z Goldhaber
(12)
,
David Jimenez
,
Matija Kozak
,
Christian Kupatt
,
Nils Kucher
,
Irene M Lang
,
Mareike Lankeit
,
Nicolas Meneveau
(2, 13)
,
Gerard Pacouret
(2, 14)
,
Massimiliano Palazzini
,
Antoniu Petris
,
Piotr Pruszczyk
,
Matteo Rugolotto
,
Aldo Salvi
,
Sebastian Schellong
(15)
,
Mustapha Sebbane
(16)
,
Bozena Sobkowicz
,
Branislav S Stefanovic
,
Holger Thiele
(17)
,
Adam Torbicki
,
Franck Verschuren
(18)
,
Stavros V Konstantinides
1
HEGP -
Hôpital Européen Georges Pompidou [APHP]
2 GIRC Thrombose
3 Service de Statistiques
4 BOEHRINGER INGELHEIM
5 PERUGIA - ICM-SU - Internal and Cardiovascular Medicine - Stroke Unit
6 DRESDEN - CGCU - Carl Gustav Carus University
7 Service de Cardiologie
8 GETBO - Groupe d'Etude de la Thrombose de Bretagne Occidentale
9 CIC - Brest - Centre d'Investigation Clinique
10 DMIP - Brest - Département de Médecine Interne et Pneumologie [Brest]
11 Department of Cardiology
12 SZG - Cardiovascular Division
13 PCVP / CARDIO - Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920)
14 TOURS - Cardiologie A - Service de Cardiologie A
15 DRESDEN-FRIEDRICHSTADT HOSPITAL - Dresden-Friedrichstadt Hospital
16 Département de Médecine d'Urgence
17 University of Cologne
18 FV - ED - Emergency Department
2 GIRC Thrombose
3 Service de Statistiques
4 BOEHRINGER INGELHEIM
5 PERUGIA - ICM-SU - Internal and Cardiovascular Medicine - Stroke Unit
6 DRESDEN - CGCU - Carl Gustav Carus University
7 Service de Cardiologie
8 GETBO - Groupe d'Etude de la Thrombose de Bretagne Occidentale
9 CIC - Brest - Centre d'Investigation Clinique
10 DMIP - Brest - Département de Médecine Interne et Pneumologie [Brest]
11 Department of Cardiology
12 SZG - Cardiovascular Division
13 PCVP / CARDIO - Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920)
14 TOURS - Cardiologie A - Service de Cardiologie A
15 DRESDEN-FRIEDRICHSTADT HOSPITAL - Dresden-Friedrichstadt Hospital
16 Département de Médecine d'Urgence
17 University of Cologne
18 FV - ED - Emergency Department
Eric Vicaut
- Fonction : Auteur
- PersonId : 912409
- ORCID : 0000-0001-6303-8557
- IdRef : 086029967
Erich Bluhmki
- Fonction : Auteur
Benjamin Brenner
- Fonction : Auteur
Claudia Dellas
- Fonction : Auteur
Klaus Empen
- Fonction : Auteur
Ana Franca
- Fonction : Auteur
Nazzareno Galiè
- Fonction : Auteur
David Jimenez
- Fonction : Auteur
- PersonId : 768891
- ORCID : 0000-0002-4571-7721
Matija Kozak
- Fonction : Auteur
Christian Kupatt
- Fonction : Auteur
Nils Kucher
- Fonction : Auteur
Irene M Lang
- Fonction : Auteur
Mareike Lankeit
- Fonction : Auteur
Massimiliano Palazzini
- Fonction : Auteur
Antoniu Petris
- Fonction : Auteur
Piotr Pruszczyk
- Fonction : Auteur
Matteo Rugolotto
- Fonction : Auteur
Aldo Salvi
- Fonction : Auteur
Bozena Sobkowicz
- Fonction : Auteur
Branislav S Stefanovic
- Fonction : Auteur
Adam Torbicki
- Fonction : Auteur
Franck Verschuren
- Fonction : Auteur
- PersonId : 762027
- ORCID : 0000-0001-7320-0589
Stavros V Konstantinides
- Fonction : Auteur
- PersonId : 958824
Résumé
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.).