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CLINICAL STUDIES

Adenosine as an adjunct to thrombolytic therapy for acute myocardial infarction

Results of a multicenter, randomized, placebo-controlled trial: the Acute Myocardial Infarction STudy of ADenosine (AMISTAD) Trial

Kenneth W. Mahaffey, MD, FACC^{a* || ¶ #}, Joseph A. Puma, DO^{a* || ¶ #}, N. Alejandro Barbagelata, MD^*, Marcelo F. DiCarli, MD, Massoud A. Leesar, MD, Kevin F. Browne, MD, Paul R. Eisenberg, MD^||, Roberto Bolli, MD, A. Cecilia Casas, MS^{a* || ¶ #}, Victor Molina-Viamonte, MD^¶, Cesare Orlandi, MD^¶, Roger Blevins, PharmD^¶, Raymond J. Gibbons, MD, FACC^#, Robert M. Califf, MD, FACC^{a* || ¶ #}, Christopher B. Granger, MD, FACC^{a* || ¶ #} for the AMISTAD Investigators

^a Duke Clinical Research Institute, Durham, North Carolina, USA
^* Favaloro Foundation, Buenos Aires, Argentina
Harper Hospital, Detroit, Michigan, USA
University of Louisville, Louisville, Kentucky, USA
The Watson Clinic, Lakeland, Florida, USA
^|| Washington University, St. Louis, Missouri, USA
^¶ Medco Research, Inc., Research Triangle Park, North Carolina, USA
^# The Mayo Clinic, Rochester, Minnesota, USA

Manuscript received September 17, 1998; revised manuscript received June 17, 1999, accepted August 12, 1999.

Reprint requests and correspondence: Dr. Kenneth W. Mahaffey, Duke Clinical Research Institute, PO Box 17969, Durham, North Carolina 27715
mahaf002{at}mc.duke.edu

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.

Abbreviations and Acronyms   AMISTAD = Acute Myocardial Infarction STudy of ADenosine   CORE = Collaborative Organization for RheothRx Evaluation (trial)   MI = myocardial infarction   SPECT = single-photon emission computed tomography   TIMI = Thrombolysis In Myocardial Infarction (trial)

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				V. Stangl, G. Baumann, K. Stangl, and S. B Felix Negative inotropic mediators released from the heart after myocardial ischaemia-reperfusion Cardiovasc Res, January 1, 2002; 53(1): 12 - 30. [Abstract] [Full Text] [PDF]

				R. A. Kloner and R. B. Jennings Consequences of Brief Ischemia: Stunning, Preconditioning, and Their Clinical Implications: Part 2 Circulation, December 18, 2001; 104(25): 3158 - 3167. [Abstract] [Full Text] [PDF]

				I. B. A. Menown and A. A. J. Adgey Cardioprotective therapy and sodium-hydrogen exchange inhibition: current concepts and future goals J. Am. Coll. Cardiol., November 15, 2001; 38(6): 1651 - 1653. [Full Text] [PDF]

				K. Mubagwa and W. Flameng Adenosine, adenosine receptors and myocardial protection: An updated overview Cardiovasc Res, October 1, 2001; 52(1): 25 - 39. [Abstract] [Full Text] [PDF]

				R. T. Smolenski, O. Raisky, E. M. Slominska, H. Abunasra, K. K. Kalsi, J. Jayakumar, K. Suzuki, and M. H. Yacoub Protection From Reperfusion Injury After Cardiac Transplantation by Inhibition of Adenosine Metabolism and Nucleotide Precursor Supply Circulation, September 18, 2001; 104(2009): I-246 - I-252. [Abstract] [Full Text] [PDF]

				G. A. Beller Coronary Heart Disease in the First 30 Years of the 21st Century: Challenges and Opportunities : The 33rd Annual James B. Herrick Lecture of the Council on Clinical Cardiology of the American Heart Association Circulation, May 22, 2001; 103(20): 2428 - 2435. [Full Text] [PDF]

				C.H. Davies Revascularization for cardiogenic shock QJM, February 1, 2001; 94(2): 57 - 67. [Full Text] [PDF]