Fibrinolysis for patients with intermediate-risk pulmonary embolism
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BORIS DOI
Date of Publication
April 10, 2014
Publication Type
Article
Division/Institute
Contributor
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 | |
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. |
Subject(s)
Series
New England journal of medicine NEJM
ISSN or ISBN (if monograph)
0028-4793
Publisher
Massachusetts Medical Society MMS
Language
English
Publisher DOI
PubMed ID
24716681
Description
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.).
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.).
File(s)
| File | File Type | Format | Size | License | Publisher/Copright statement | Content | |
|---|---|---|---|---|---|---|---|
| Fibrinolysis for patients with intermediate-risk.pdf | text | Adobe PDF | 455.08 KB | published |