[en] This study was designed to determine the clinical risk for hard events after normal single-photon emission computed tomography (SPECT) and to identify the predictors of increased risk in asymptomatic patients with diabetes mellitus, based on a Japanese Assessment of Cardiac Events and Survival Studies by quantitative gated SPECT (J-ACCESS)-2 study. A total of 513 consecutive asymptomatic patients who underwent stress ^99mTc-tetrofosmin SPECT in Japan were included in this study. Based on SPECT image and QGS data, 319 had a summed stress score ≤3, a summed difference score <2 and normal cardiac function (end-systolic volume ≤60 ml, males, ≤40 ml females; left ventricular ejection fraction ≥49%, males, ≥50% females). Myocardial perfusion was normal in 62% of this study population. During a 3-year follow-up, there were a total of 8 cardiac major events (2.5%): 2 cases of sudden death, 5 of acute coronary syndrome, and 1 of hospitalization because of congestive heart failure. The annual major event rate was 0.8%. Subjects undergoing coronary angiography had significantly more major events than those who did not among normal SPECT subjects (P=0.01). Kaplan-Meier analysis showed that the cardiac major events rate was very low, and subjects with normal SPECT can be considered as low risk among asymptomatic patients with diabetes. An excellent prognosis was associated with a normal SPECT in asymptomatic patients with diabetes, so these patients can be exempted from further invasive procedure. (author)