Clinical Research
Coronary Artery Disease
A Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial of Adenosine as an Adjunct to Reperfusion in the Treatment of Acute Myocardial Infarction (AMISTAD-II)

https://doi.org/10.1016/j.jacc.2005.02.061Get rights and content
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Objectives

The purpose of this research was to determine the effect of intravenous adenosine on clinical outcomes and infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing reperfusion therapy.

Background

Previous small studies suggest that adenosine may reduce the size of an evolving infarction.

Methods

Patients (n = 2,118) with evolving anterior STEMI receiving thrombolysis or primary angioplasty were randomized to a 3-h infusion of either adenosine 50 or 70 μg/kg/min or of placebo. The primary end point was new congestive heart failure (CHF) beginning >24 h after randomization, or the first re-hospitalization for CHF, or death from any cause within six months. Infarct size was measured in a subset of 243 patients by technetium-99m sestamibi tomography.

Results

There was no difference in the primary end point between placebo (17.9%) and either the pooled adenosine dose groups (16.3%) or, separately, the 50-μg/kg/min dose and 70-μg/kg/min groups (16.5% vs. 16.1%, respectively, p = 0.43). The pooled adenosine group trended toward a smaller median infarct size compared with the placebo group, 17% versus 27% (p = 0.074). A dose-response relationship with final median infarct size was seen: 11% at the high dose (p = 0.023 vs. placebo) and 23% at the low dose (p = NS vs. placebo). Infarct size and occurrence of a primary end point were significantly related (p < 0.001).

Conclusions

Clinical outcomes in patients with STEMI undergoing reperfusion therapy were not significantly improved with adenosine, although infarct size was reduced with the 70-μg/kg/min adenosine infusion, a finding that correlated with fewer adverse clinical events. A larger study limited to the 70-μg/kg/min dose is, therefore, warranted.

Abbreviations and Acronyms

AMISTAD
Acute Myocardial Infarction Study of Adenosine
CHF
congestive heart failure
DSMB
Data Safety Monitoring Board
ITT
intention to treat
MI
myocardial infarction
STEMI
ST-segment elevation myocardial infarction

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