Infarct Size Measured by Single Photon Emission Computed Tomographic Imaging With 99m Tc-Sestamibi

BACKGROUND: Use of mortality as an end point in randomized trials of reperfusion therapy requires increasingly large sample sizes to test advances compared with existing therapy, which is already highly effective. There has been a growing interest in infarct size measurements by (99m)Tc-sestamibi SPECT (single photon emission computed tomographic) imaging as a surrogate end point. METHODS AND RESULTS: We reviewed the reports published in English regarding infarct size measurements by (99m)Tc-sestamibi. Four separate lines of published evidence support the validity of SPECT imaging with (99m)Tc-sestamibi for determination of infarct size. This end point has been used in a total of 7 randomized trials-1 single center and 6 multicenter. The end point compares favorably with left ventricular function and infarct size measurements with the use of other radiopharmaceuticals. The most important limitation of this approach is the absence thus far of a randomized trial that has shown a corresponding decrease in mortality in association with a therapy that reduces infarct size. CONCLUSIONS: SPECT imaging with (99m)Tc-sestamibi is the best available measurement tool for infarct size. It has already served as an end point in early pilot studies to evaluate potential efficacy and in dose-ranging studies. It has the potential to serve as a surrogate end point to uncover advantages of new therapies that may be equivalent to existing therapies with respect to early mortality.