The incidence of bleeding AEs by clinical characteristics is shown in Table 3. The incidence of bleeding AEs was significantly higher in female patients, patients aged 75 years or older, patients with low body weight (50 kg or less), patients with severe cardiovascular disease (Killip Class III or IV), patients without dyslipidemia, and patients with severe renal impairment (creatinine clearance less than 30 mL/min). The proportion of female patients weighing 50 kg or less who experienced bleeding AEs was 40.9% (9/22), compared with 16.0% (4/25) among male patients with bleeding AEs weighing 50 kg or less. Furthermore, puncture site hemorrhage and subcutaneous hemorrhage were reported more frequently in female patients [2.9% (5/172) and 1.7% (3/172), respectively], than in males [0.2% (1/560) and 0.2% (1/560)]. In contrast, variations in timing of the initial LD (before, during, or after PCI) did not significantly affect the occurrence of bleeding AEs.Table 3Incidence of bleeding adverse events by clinical characteristicPatients, N Patients with bleeding AEs, N (%) P value*Safety analysis set73247 (6.4)–Sex Male56025 (4.5)<0.0001 Female17222 (12.8)Age (years) <7551122 (4.3)0.0004 ≥7522125 (11.3)Body weight (kg)a ≤509413 (13.8)0.0008 >5061030 (4.9)Final diagnosisa STEMI43933 (7.5)0.4138 NSTEMI923 (3.3) UAP19811 (5.6)Killip classificationa Class I57229 (5.1)0.0302 Class II918 (8.8) Class III152 (13.3) Class IV497 (14.3)Prior MIa Absent65344 (6.7)0.1983 Present712 (2.8)Prior revascularizationsa Absent63443 (6.8)0.1951 Present923 (3.3)Prior CABG Absent72547 (6.5)0.4862 Present70 (0.0)Prior TLR Absent69945 (6.4)0.9312 Present332 (6.1)Prior ischemic strokea Absent68845 (6.5)0.3508 Present371 (2.7)Hypertension Absent17311 (6.4)0.9694 Present55936 (6.4)Dyslipidemia Absent16720 (12.0)0.0009 Present56527 (4.8)Diabetes mellitus Absent46528 (6.0)0.5609 Present26719 (7.1)History of smokinga Absent46236 (7.8)0.0841 Present24911 (4.4)Baseline Ccra (mL/min) Normal (>80)2999 (3.0)0.0043 Mild (>50 to ≤80)23818 (7.6) Moderate (≥30 to ≤50)979 (9.3) Severe (<30)487 (14.6)Timing of loadinga Before PCIb 53337 (6.9)0.5973 During PCIc 713 (4.2) After PCId 613 (4.9)Prasugrel + aspirin Not used543 (5.6)0.7875 Used67844 (6.5)Prasugrel + aspirin + WF or DOAC Not used71345 (6.3)0.4595 Used192 (10.5)Prasugrel + NSAIDs (w/o aspirin) Not used72147 (6.5)0.3814 Used110 (0.0)PPIs Not used38523 (6.0)0.6035 Used34724 (6.9) NSTEMI non-ST-segment elevation myocardial infarction, STEMI ST-segment elevation myocardial infarction, UAP unstable angina pectoris, MI myocardial infarction; CABG coronary artery bypass graft, TLR target lesion revascularization, Ccr creatinine clearance, WF warfarin, DOAC direct oral anti-coagulant, NSAIDs non-steroidal anti-inflammatory drugs, PPIs proton pump inhibitors, PCI percutaneous coronary intervention* χ 2 test aBody weight, Killip class, prior MI, prior revascularization, prior ischemic stroke, history of smoking, and timing of loading dose were unknown in 28, 5, 8, 6, 7, 21, and 31 patients, respectively. Three patients had a final diagnosis other than STEMI, NSTEMI, or UAP. Baseline Ccr was not calculated in 50 patients bGiven before the initial balloon passage in PCI cGiven from the initial balloon passage in PCI until discharge from the PCI room dGiven after discharge from the PCI room