Category | Group A (N=3395) | Group B (N=1755) | P value | |||
n (%) | Event | n (%) | Event | Group A vs B | ||
Overall macrovascular events | 92 (2.71) | 109 | 52 (2.96) | 62 | 0.594 | |
Acute coronary syndrome | 1 (0.03) | 1 | 0 (0.00) | 0 | 1.000 | |
Myocardial infarction | 17 (0.50) | 17 | 9 (0.51) | 12 | 1.000 | |
Stroke | Cerebral infarction | 29 (0.85) | 32 | 20 (1.14) | 20 | 0.363 |
Cerebral hemorrhage | 11 (0.32) | 11 | 3 (0.17) | 3 | 0.406 | |
Heart failure | 27 (0.80) | 33 | 11 (0.63) | 13 | 0.607 | |
Coronary angioplasty | PCI | 2 (0.06) | 2 | 2 (0.11) | 3 | 0.609 |
CABG | 1 (0.03) | 1 | 0 (0.00) | 0 | 1.000 | |
PAD | 8 (0.24) | 9 | 7 (0.40) | 8 | 0.413 | |
Unstable angina | 3 (0.09) | 3 | 3 (0.17) | 3 | 0.416 |
Macrovascular events were selected on symptomatic basis, but events deemed on test/examination basis were not included. The events selected and categorized in the table were acute coronary syndrome, myocardial infarction (acute myocardial infarction and myocardial infarction), cerebral infarction (brain stem infarction, cerebellar infarction, cerebral infarction, cerebral thrombosis, lacunar infarction, thalamic infarction, and thrombotic cerebral infarction), cerebral hemorrhage (brain stem hemorrhage, cerebellar hemorrhage, cerebral hemorrhage, subarachnoid hemorrhage, thalamus hemorrhage, and putamen hemorrhage), heart failure (cardiac failure, cardiac failure acute, cardiac failure chronic, and cardiac failure congestive), PCI (coronary angioplasty and stent placement), CABG (coronary artery bypass), PAD (peripheral arterial occlusive disease), and unstable angina. Incidence (%) was calculated as a division of n for individual AE category by either 3395 (group A) or 1755 (group B). P values were based on Fisher’s exact test.
AE, adverse event; CABG, coronary artery bypass grafting; PAD, peripheral artery disease; PCI, percutaneous coronary intervention.