|Adjunctive transcutaneous ultrasound with thrombolysis: results of the PLUS (Perfusion by ThromboLytic and UltraSound) trial.|
|PMID: 20298997 Owner: NLM Status: MEDLINE|
|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.
|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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|Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't|
|Title: JACC. Cardiovascular interventions Volume: 3 ISSN: 1876-7605 ISO Abbreviation: JACC Cardiovasc Interv Publication Date: 2010 Mar|
|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|
|Languages: eng Pagination: 352-9 Citation Subset: IM|
|Copyright (c) 2010 American College of Cardiology Foundation.Published by Elsevier Inc. All rights reserved.|
|APA/MLA Format Download EndNote Download BibTex|
Combined Modality Therapy
Coronary Circulation / drug effects
Early Termination of Clinical Trials
Heart Rupture, Post-Infarction / etiology
Hemorrhage / etiology
Myocardial Infarction / diagnosis, drug therapy, mortality, physiopathology, therapy*
Stroke / etiology
Thrombolytic Therapy* / adverse effects, instrumentation
Ultrasonic Therapy* / adverse effects
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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