Adjunctive Transcutaneous Ultrasound With Thrombolysis: Results of the PLUS (Perfusion by ThromboLytic and UltraSound) Trial

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• 作者：Michael Hudson ; MD ; MHS^?/sup> ; ^{mhudson1@hfhs.org} ; Adam Greenbaum ; MD^?/sup> ; Laura Brenton ; BSN^?/sup> ; C. Michael Gibson ; MD ; MS^&dagger ; ; Robert Siegel ; MD^&Dagger ; ; Lisa R. Reeves ; MS^§ ; ; Miguel Fiol Sala ; MD^?/sup> ; George McKendall ; MD^¶ ; ; Jorge Bluguermann ; MD^# ; Debra Echt ; MD^?/sup>?/sup> ; E. Magnus Ohman ; MD^&dagger ; &dagger ; ; W. Douglas Weaver ; MD^?/sup>
• 关键词：acute myocardial infarction ; angioplasty ; fibrinolysis ; reperfusion ; ultrasound
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2010
• 出版时间：March 2010
• 年：2010
• 卷：3
• 期：3
• 页码：352-359
• 全文大小：547 K

文摘

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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 ? 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¡ªdeath, reinfarction, recurrent ischemia, stroke, major bleed, left ventricular rupture (9.7 % vs. 10.2 % ; p = 0.88)¡ªdid 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.