A Randomized Trial Testing US Food and Drug Administration “Breakthrough” Language

patients with atrial fibrillation with high global cardiovascular risk, the yield for detecting ischemia was 5.2%, and ischemia was not associated with increased mortality in this population.These findings suggest that these asymptomatic patients do not benefit from MPI. Harms of MPI include increased cancer risk from the high radiation burden (6-37 mSv depending on protocol, which is equivalent to hundreds or thousands of chest radiographs).These findings support a change in the AUC rating to the rarely appropriate category for this indication, and because MPI has definite harms without benefits for asymptomatic patients with atrial fibrillation this Research Letter merits the Less is More designation.