Table 3 Primary and secondary outcome events. Data were compared using Chi-square test or Fisher's exact test. *1 cerebral hemorrhage, 1 hemoglobin drop needing transfusion in the clopidogrel group. †2 epistaxis, 1 upperarm petechiae in the clopidogrel group, 1 vitreous hemorrahge in the sarpogrelate group. ‡Causes of death were septic shock (n = 1), heart failure (n = 1), unknown (n = 1) in clopidogrel group, and myocardial infarction (n = 1), bowel perforation (n = 1) in the sarpogrelate group. § Any serious adverse event defined as all-cause death, ischemic stroke, transient ischemic attack, systemic embolism, acute coronary syndrome, early thrombotic occlusion, major bleeding, and major amputation.
Clopidogrel group | Sarpogrelate group | p value | |
|---|---|---|---|
Primary outcome events – per-protocol set | n = 110 | n = 100 | |
Target lesion restenosis, n (%) | 21 (18.8%) | 14 (13.3%) | 0.28 |
Secondary outcome events – full analysis set | n = 137 | n = 133 | |
Target lesion revascularization, n (%) | 2 (1.5%) | 2 (1.6%) | 1.00 |
Target vessel revascularization, n (%) | 0 (0%) | 1 (0.8%) | 0.49 |
Major amputation,n (%) | 0 (0%) | 0 (0%) | |
Acute coronary syndrome, n (%) | 0 (0%) | 3 (2.4%) | 0.12 |
Ischemic stroke, n (%) | 1 (0.8%) | 0 (0%) | 1.00 |
Transient ischemic attack, n (%) | 0 (0%) | 0 (0%) | |
Systemic embolism, n (%) | 0 (0%) | 0 (0%) | |
Major bleeding complication, n (%)* | 2 (1.5%) | 0 (0%) | 0.50 |
Minor bleeding complication, n (%)† | 3 (2.3%) | 1 (0.8%) | 0.62 |
All-cause mortality, n (%)‡ | 3 (2.2%) | 2 (1.5%) | 1.00 |
Any serious adverse events, n (%)§ | 6 (4.4%) | 5 (3.8%) | 0.80 |
