Though the overall incidences of bleeding AEs were lower in this study in comparison with PRASFIT-ACS , after calculating the total risk score in association with the incidence of bleeding AEs, we found that the risk of bleeding increased if patients had four or all five risk factors: “female sex”, “age of 75 years or older”, “body weight of 50 kg or less”, “severe cardiovascular disease”, and “severe renal impairment”. Another study assessed the risk of bleeding in patients with ACS undergoing PCI abroad; these investigators concluded that patients with ACS have marked variability in the risk of bleeding according to sex, age, and serum creatinine, among other factors . A study by Saito et al. , which examined periprocedural bleeding in relation to the access route for PCI in a Japanese sample, found that sex, body weight, and age were risk factors, observations that are in line with our findings. There is a possibility that the risk of bleeding will increase in the above-mentioned patients. However, an analysis adjusting for confounding effects on each risk factor was not performed. Furthermore, as a limited number of patients with severe cardiac dysfunction were evaluated in clinical trials (these patients were generally excluded), these patients will be evaluated in the ongoing PRASFIT-Practice II study, a long-term observational study in patients with ischemic heart disease.