A Post-marketing Clinical Study to Confirm the Efficacy of ¹⁸F-fluorodeoxyglucose for the Diagnosis of Myocardial Viability

A Prospective Multicenter Study in Patients with Ischemic Heart Disease

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Background: A number of previous studies have shown that myocardial viability can be assessed by positron emission tomography (PET) using ¹⁸F-fluorodeoxyglucose (¹⁸F-FDG). However, there has been no multicenter study that verified the ability of this modality for diagnosing myocardial viability in Japan. We therefore conducted a prospective one arm’s unrandomized multicenter clinical trial in order to confirm the diagnostic ability of ¹⁸F-FDG for myocardial viability.
Methods: This study included patients with heart failure and impaired left ventricular function where conventional myocardial perfusion scintigraphy was not contributive for the diagnosis of myocardial viability,and assessed the diagnostic ability of ¹⁸F-FDG for myocardial viability in these patients. The diagnostic ability was determined on the basis of post-coronary vascularization improvement in myocardial wall motion in a myocardial segment with ¹⁸F-FDG uptake (i.e., positive predictive value). We also assessed the safety of ¹⁸F-FDG.
Results: Out of 49 patients who received ¹⁸F-FDG administration, 30 were included in the efficacy analysis set (mean age 64.4±14.6 years; 27 men and 3 women; mean follow-up period 228.6±74.5 days). The positive predictive value of ¹⁸F-FDG (95% two-sided confidence interval) in the 30 patients of the efficacy-analysis set was 63.9% (54.6-72.5%). Moreover, the proportion of patients with improved wall motion, on a per-patient basis, was 86.7% (26 of 30 cases). As for the safety, no serious adverse events occurred and the agent was well-tolerated.
Conclusions: The identification of myocardial viability by ¹⁸F-FDG will be widely beneficial in predicting improvement in myocardial wall motion after coronary revascularization. No serious safety concerns associated with the use of ¹⁸F-FDG were observed.