TY - JOUR
T1 - Adenosine as an adjunct to thrombolytic therapy for acute myocardial infarction - Results of a multicenter, randomized, placebo-controlled trial
T2 - The acute myocardial infarction STudy of ADenosine (AMISTAD) trial
AU - Mahaffey, Kenneth W.
AU - Puma, Joseph A.
AU - Barbagelata, N. Alejandro
AU - Dicarli, Marcelo F.
AU - Leesar, Massoud A.
AU - Browne, Kevin F.
AU - Eisenberg, Paul R.
AU - Bolli, Roberto
AU - Casas, A. Cecilia
AU - Molina-Viamonte, Victor
AU - Orlandi, Cesare
AU - Blevins, Roger
AU - Gibbons, Raymond J.
AU - Califf, Robert M.
AU - Granger, Christopher B.
N1 - Funding Information:
This study was supported by Medco Research, Inc. (Research Triangle Park, North Carolina) and Fujisawa USA, Inc. (Deerfield, Illinois).
PY - 1999/11/15
Y1 - 1999/11/15
N2 - OBJECTIVES: The Acute Myocardial Infarction STudy of ADenosine (AMISTAD) trial was designed to test the hypothesis that adenosine as an adjunct to thrombolysis would reduce myocardial infarct size. BACKGROUND: Reperfusion therapy for acute myocardial infarction (MI) has been shown to reduce mortality, but reperfusion itself also may have deleterious effects. METHODS: The AMISTAD trial was a prospective, open-label trial of thrombolysis with randomization to adenosine or placebo in 236 patients within 6 h of infarction onset. The primary end point was infarct size as determined by Tc-99 m sestamibi single- photon emission computed tomography (SPECT) imaging 6 ± 1 days after enrollment based on multivariable regression modeling to adjust for covariates. Secondary end points were myocardial salvage index and a composite of in-hospital clinical outcomes (death, reinfarction, shock, congestive heart failure or stroke). RESULTS: In all, 236 patients were enrolled. Final infarct size was assessed in 197 (83%) patients. There was a 33% relative reduction in infarct size (p = 0.03) with adenosine. There was a 67% relative reduction in infarct size in patients with anterior infarction (15% in the adenosine group vs. 45.5% in the placebo group) but no reduction in patients with infarcts located elsewhere (11.5% for both groups). Patients randomized to adenosine tended to reach the composite clinical end point more often than those assigned to placebo (22% vs. 16%; odds ratio, 1.43; 95% confidence interval, 0.71 to 2.89). CONCLUSIONS: Many agents thought to attenuate reperfusion injury have been unsuccessful in clinical investigation. In this study, adenosine resulted in a significant reduction in infarct size. These data support the need for a large clinical outcome trial.
AB - OBJECTIVES: The Acute Myocardial Infarction STudy of ADenosine (AMISTAD) trial was designed to test the hypothesis that adenosine as an adjunct to thrombolysis would reduce myocardial infarct size. BACKGROUND: Reperfusion therapy for acute myocardial infarction (MI) has been shown to reduce mortality, but reperfusion itself also may have deleterious effects. METHODS: The AMISTAD trial was a prospective, open-label trial of thrombolysis with randomization to adenosine or placebo in 236 patients within 6 h of infarction onset. The primary end point was infarct size as determined by Tc-99 m sestamibi single- photon emission computed tomography (SPECT) imaging 6 ± 1 days after enrollment based on multivariable regression modeling to adjust for covariates. Secondary end points were myocardial salvage index and a composite of in-hospital clinical outcomes (death, reinfarction, shock, congestive heart failure or stroke). RESULTS: In all, 236 patients were enrolled. Final infarct size was assessed in 197 (83%) patients. There was a 33% relative reduction in infarct size (p = 0.03) with adenosine. There was a 67% relative reduction in infarct size in patients with anterior infarction (15% in the adenosine group vs. 45.5% in the placebo group) but no reduction in patients with infarcts located elsewhere (11.5% for both groups). Patients randomized to adenosine tended to reach the composite clinical end point more often than those assigned to placebo (22% vs. 16%; odds ratio, 1.43; 95% confidence interval, 0.71 to 2.89). CONCLUSIONS: Many agents thought to attenuate reperfusion injury have been unsuccessful in clinical investigation. In this study, adenosine resulted in a significant reduction in infarct size. These data support the need for a large clinical outcome trial.
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U2 - 10.1016/S0735-1097(99)00418-0
DO - 10.1016/S0735-1097(99)00418-0
M3 - Article
C2 - 10577561
AN - SCOPUS:0033571512
SN - 0735-1097
VL - 34
SP - 1711
EP - 1720
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 6
ER -