| Bolus tenecteplase for right ventricle dysfunction in hemodynamically stable patients with pulmonary embolism. | |
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MedLine Citation:
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PMID: 19833379 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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INTRODUCTION: The clinical benefit of thrombolytic treatment over heparin in patients with pulmonary embolism without hemodynamic compromise remains controversial. In these patients bolus tenecteplase has the potential to provide an effective and safe thrombolysis. METHODS: We evaluated the effect of tenecteplase on right ventricle dysfunction (RVD) assessed by echocardiography in hemodynamically stable patients with PE in a multicenter, randomized, double-blind, placebo-controlled study. RVD was defined as right/left ventricle end-diastolic dimension ratio >1 in the apical 4-chamber view. Patients were randomized to receive weight-adjusted single-bolus tenecteplase or placebo. All patients received unfractionated heparin. Reduction of RVD at 24 hours was the primary efficacy end-point and was evaluated by an independent committee unaware of treatment allocation. RESULTS: Overall, 58 patients were randomized. Echocardiograms were adequate for efficacy analysis in 51 patients, 23 randomized to tenecteplase and 28 to placebo. The reduction of right to left ventricle end-diastolic dimension ratio at 24 hours was 0.31+/-0.08 in patients randomized to tenecteplase as compared to 0.10+/-0.07 in patients randomized to placebo (p=0.04). One patient randomized to tenecteplase suffered a clinical event (recurrent pulmonary embolism) in comparison to three patients randomized to placebo (1 recurrent pulmonary embolism; 1 clinical deterioration and 1 non pulmonary embolism-related death). Two non fatal major bleedings occurred with tenecteplase (1 intracranial) and one with placebo. CONCLUSION: In hemodynamically stable patients with PE, treatment with single bolus tenecteplase is feasible at the same dosages used for acute myocardial infarction and is associated with reduction of RVD at 24 hours. Whether this benefit is associated with an improved clinical outcome without excessive bleeding is currently explored in a large clinical trial. |
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Authors:
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Cecilia Becattini; Giancarlo Agnelli; Aldo Salvi; Stefano Grifoni; Leonardo Goffredo Pancaldi; Iolanda Enea; Franco Balsemin; Mauro Campanini; Angelo Ghirarduzzi; Franco Casazza; |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-10-14 |
Journal Detail:
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Title: Thrombosis research Volume: 125 ISSN: 1879-2472 ISO Abbreviation: Thromb. Res. Publication Date: 2010 Mar |
Date Detail:
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Created Date: 2010-03-01 Completed Date: 2010-07-01 Revised Date: 2011-05-23 |
Medline Journal Info:
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Nlm Unique ID: 0326377 Medline TA: Thromb Res Country: United States |
Other Details:
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Languages: eng Pagination: e82-6 Citation Subset: IM |
Copyright Information:
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(c) 2009 Elsevier Ltd. All rights reserved. |
Affiliation:
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Medicina Interna e Cardiovascolare-Stroke Unit, Università di Perugia, Perugia, Italy. cecilia.becattini@unipg.it |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00222651 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Anticoagulants / therapeutic use Dosage Forms Double-Blind Method Drug Administration Schedule Drug Therapy, Combination Echocardiography Feasibility Studies Female Fibrinolytic Agents / administration & dosage, therapeutic use* Hemorrhage / complications Heparin / therapeutic use Humans Male Middle Aged Pilot Projects Pulmonary Embolism / complications*, ultrasonography Tissue Plasminogen Activator / administration & dosage, therapeutic use* Treatment Outcome Ventricular Dysfunction, Right / drug therapy*, ultrasonography |
| Chemical | |
Reg. No./Substance:
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0/Anticoagulants; 0/Dosage Forms; 0/Fibrinolytic Agents; 0/tenecteplase; 9005-49-6/Heparin; EC 3.4.21.68/Tissue Plasminogen Activator |
| Investigator | |
Investigator/Affiliation:
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Pietro Berra Centurini / ; Francesco Bovenzi / ; Daniele Coen / ; Antonio Palla / ; Fernando Porro / ; Jorge Antonio Salerno Uriarte / |
| Comments/Corrections | |
Comment In:
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Thromb Res. 2010 Dec;126(6):e407-8
[PMID:
19896704
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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