Fibrinolysis for patients with intermediate-risk pulmonary embolism.
By G. Meyer, E. Vicaut, T. Danays, G. Agnelli, C. Becattini, J. Beyer-Westendorf, E. Bluhmki, H. Bouvaist, B. Brenner, F. Couturaud and 27 more. New England Journal of Medicine, 2014
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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.).
Subfields: Cardiology and Cardiovascular Medicine, Internal Medicine, Pulmonary and Respiratory Medicine
View Paper: https://www.semanticscholar.org/paper/a5d9da6063786906cf3603320e678b9b66572c6f
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Citations in the corpus
- ESC Guidelines on the diagnosis and management of acute pulmonary embolism (2014, background): “001).(253) These results underline the need to improve the safety of thrombolytic treatment in patients at increased risk of intracranial or other life-threatening bleeding.”
- [2014 ESC Guidelines on the diagnosis and management of acute pulmonary embolism]. (2014, positive): “001).(253) These results underline the need to improve the safety of thrombolytic treatment in patients at increased risk of intracranial or other life-threatening bleeding.”
- A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. (2015, background): “In the largest study of full-dose systemic fibrinolysis, tenecteplase reduced the risk of death or cardiovascular collapse by 56% in 1,006 submassive PE patients (5).”
- Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. (2012, methodology): “Most of the new evidence comes from the Pulmonary Embolism Thrombolysis trial, which randomized 1,006 patients with PE and right ventricular dysfunction to tenecteplase and heparin or to heparin therapy alone (with placebo).(143) The most notable findings of this study were that thrombolytic therapy”
- Thrombolysis for pulmonary embolism and risk of all-cause mortality, major bleeding, and intracranial hemorrhage: a meta-analysis. (2014, neutral): “Ly et al,25 1978 25 Streptokinase (250 000 IU loading dose, then 100 000 IU/h for 72 h) Heparin Not prespecified 10 a 4 (16) 2 (8) 19 (76) 53.”
- American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. (2020, background): “Summary of the evidence We identified 29 systematic reviews(151-179) and 26 RCTs (n 5 2787).(130,180-204) Trials included individuals with an objectively confirmed symptomatic PE.”