Document Detail


Adjunctive transcutaneous ultrasound with thrombolysis: results of the PLUS (Perfusion by ThromboLytic and UltraSound) trial.
MedLine Citation:
PMID:  20298997     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: We investigated whether transcutaneous ultrasound (TUS) augments coronary thrombolysis and achieves higher rates of Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 and ST-segment resolution in patients with ST-segment elevation myocardial infarction (STEMI).
BACKGROUND: In animal coronary and peripheral artery thrombosis models, low-frequency TUS enhances and accelerates thrombolysis.
METHODS: In a double-blind, randomized, controlled international clinical trial, 396 patients with STEMI < or =6 h were randomized to thrombolysis alone or thrombolysis plus TUS. The 60 minute TIMI flow grade, ST-segment resolution (primary end points) and other angiographic, electrocardiographic, and clinical outcomes were compared between treatment groups.
RESULTS: The trial was halted after Safety and Efficacy Monitoring Committee interim analysis that demonstrated lack of treatment efficacy. In total, 360 patients were evaluable for angiographic, electrocardiographic, or clinical end points. Sixty minutes after thrombolytic administration, the proportion of patients achieving TIMI flow grade 3 did not differ between TUS and control groups (40.7% vs. 48.5%, respectively; p = 0.10). Achievement of >50% ST-segment resolution at 60 min did not differ between TUS and control groups (53.2% vs. 50.0%; p = 0.93). Thirty-day mortality and composite clinical events-death, reinfarction, recurrent ischemia, stroke, major bleed, left ventricular rupture (9.7 % vs. 10.2%; p = 0.88)-did not differ between TUS and control patients.
CONCLUSIONS: Thrombolysis plus TUS failed to improve 60-min TIMI flow grade or ST-segment resolution versus thrombolysis alone.
Authors:
Michael Hudson; Adam Greenbaum; Laura Brenton; C Michael Gibson; Robert Siegel; Lisa R Reeves; Miguel Fiol Sala; George McKendall; Jorge Bluguermann; Debra Echt; E Magnus Ohman; W Douglas Weaver
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  3     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-03-19     Completed Date:  2010-06-17     Revised Date:  2014-09-05    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  352-9     Citation Subset:  IM    
Copyright Information:
Copyright (c) 2010 American College of Cardiology Foundation.Published by Elsevier Inc. All rights reserved.
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MeSH Terms
Descriptor/Qualifier:
Aged
Argentina
Combined Modality Therapy
Coronary Angiography
Coronary Circulation / drug effects
Double-Blind Method
Early Termination of Clinical Trials
Electrocardiography
Equipment Design
Europe
Female
Heart Rupture, Post-Infarction / etiology
Hemorrhage / etiology
Humans
Logistic Models
Male
Middle Aged
Myocardial Infarction / diagnosis,  drug therapy,  mortality,  physiopathology,  therapy*
North America
Recurrence
Risk Assessment
Stroke / etiology
Thrombolytic Therapy* / adverse effects,  instrumentation
Time Factors
Treatment Outcome
Ultrasonic Therapy* / adverse effects

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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