Notably, the incidence of bleeding AEs in this study was significantly higher in female patients and patients with severe cardiovascular disease (Killip Class III or IV), in addition to patients aged 75 years or older, patients with low body weight (50 kg or less), and patients with severe renal impairment. For the elderly, patients with low body weight, and patients with severe renal impairment, prasugrel treatment should be administered with caution as specified in the “Careful Administration” section of the package insert. Women generally have lower body weight than men, and there are differences in skin tissue structure between the sexes. Therefore, the fact that a higher proportion of female patients reported subcutaneous hemorrhage is likely to be related to these observed sex differences. In fact, the second most common bleeding AE was general disorders and administration site conditions (e.g., puncture site hemorrhage) (1.0%); thus, measures to prevent puncture site bleeding might also be required. Results of the MATRIX Access study , a clinical trial conducted in European ACS patients who were about to undergo CAG and PCI, suggested that radial access compared with femoral access decreased the net AEs through a reduction in major bleeding AEs and death. Furthermore, in PRASFIT-ACS, the incidence of puncture site bleeding during PCI was lower in the radial access route group than in the femoral access route group . In this study, there was no difference in the number of patients with puncture site bleeding AEs between groups undergoing PCI via different puncture sites, which was likely because the incidence of patients with puncture site bleeding AEs was low [1.0% (7/732)], even though it was the second most common bleeding AE. The reason for the low incidence of puncture site bleeding AEs may be that—in contrast with PRASFIT-ACS—the proportion of patients undergoing PCI via femoral access was lower (43.0%) than that undergoing PCI via radial access (51.1%). Therefore, radial access seems more appropriate for preventing puncture site bleeding. In this study, the timing of the LD did not appear to significantly affect the incidence of bleeding AEs.