| Thrombolysis with recombinant unglycosylated single-chain urokinase-type plasminogen activator (saruplase) in acute myocardial infarction: influence of heparin on early patency rate (LIMITS study). Liquemin in Myocardial Infarction During Thrombolysis With Saruplase. | |
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MedLine Citation:
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PMID: 7608436 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVES: The Liquemin in Myocardial Infarction During Thrombolysis With Saruplase (LIMITS) study was instituted to evaluate and characterize the effect of a prethrombolytic heparin bolus (5,000 IU) on the efficacy and safety of saruplase in patients with acute myocardial infarction. BACKGROUND: Heparin has been used after thrombolytic therapy for acute myocardial infarction to prevent reocclusion of the infarct-related artery. METHODS: The study was designed as a randomized, parallel-group, double-blind, multicenter trial. Patients were treated within 6 h of onset of symptoms with either a bolus of 5,000 IU of heparin (Liquemin) (n = 56, HSH group) or placebo (n = 62, PSH group) before thrombolytic treatment with saruplase given as a 20-mg bolus followed by an infusion of 60 mg over 60 min. Thirty minutes after completion of thrombolysis, an intravenous heparin infusion was administered for 5 days. Before coronary angiography was performed at 6 to 12 h after start of lysis, an additional bolus of 5,000 IU heparin was given to all patients. End points studied were patency of the infarct-related artery, changes in the hemostatic system and bleeding complications. RESULTS: In the HSH group (heparin-saruplase-heparin), 78.6% of patients had an open infarct-related vessel (Thrombolysis in Myocardial Infarction [TIMI] flow grade 2 or 3) compared with 56.5% in the PSH group (placebo-saruplase-heparin) (intention-to-treat analysis, p = 0.01). No significant difference was observed between the two groups with regard to changes in fibrinogen and fibrin/fibrinogen degradation products. A total of eight bleeding complications (14.3%) were observed in the HSH group and five (8.1%) in the PSH group; no cerebrovascular event occurred, and no allergic reaction was reported. A total of 12 patients died during the hospital stay, 3 in the HSH group (5.4%) and 9 in the PSH group (14.5%). CONCLUSIONS: In acute myocardial infarction, the administration of a heparin bolus before thrombolytic therapy with saruplase is associated with a significantly higher patency at angiography 6 to 12 h after the start of thrombolysis without any appreciable increase in risk of bleeding. |
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Authors:
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U Tebbe; J Windeler; I Boesl; H Hoffmann; J Wojcik; M Ashmawy; E R?diger Schwarz; P von Loewis; P Rosemeyer; G Hopkins |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: Journal of the American College of Cardiology Volume: 26 ISSN: 0735-1097 ISO Abbreviation: J. Am. Coll. Cardiol. Publication Date: 1995 Aug |
Date Detail:
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Created Date: 1995-08-17 Completed Date: 1995-08-17 Revised Date: 2010-03-24 |
Medline Journal Info:
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Nlm Unique ID: 8301365 Medline TA: J Am Coll Cardiol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 365-73 Citation Subset: AIM; IM |
Affiliation:
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Gruenenthal GmbH, Aachen, Germany. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Amino Acid Sequence Confounding Factors (Epidemiology) Double-Blind Method Drug Administration Schedule Drug Therapy, Combination Enzyme Precursors / therapeutic use* Female Fibrinolytic Agents / therapeutic use* Heparin / administration & dosage, therapeutic use* Humans Injections, Intravenous Male Middle Aged Molecular Sequence Data Myocardial Infarction / drug therapy* Recombinant Proteins / therapeutic use Thrombolytic Therapy* Time Factors Treatment Outcome Urokinase-Type Plasminogen Activator / therapeutic use* Vascular Patency / drug effects* |
| Chemical | |
Reg. No./Substance:
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0/Enzyme Precursors; 0/Fibrinolytic Agents; 0/Recombinant Proteins; 9005-49-6/Heparin; 99149-95-8/saruplase; EC 3.4.21.73/Urokinase-Type Plasminogen Activator |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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