Supplementary Table 1. Incidence of Adverse Drug Reaction for One Year by Group, N (%)

Supplementary table 1. Incidence of adverse drug reaction for one year by group, n (%)

Total
(n=4049) / NSTE-ACS
(n=2708) / SA/OMI
(n=474) / STEMI
(n=787) / P Valuea
Serious / Total / Serious / Total / Serious / Total / Serious / Total / Serious / Total
Number of Patients with events / 166 / (4.1) / 433 / (10.7) / 87 / (3.2) / 273 / (10.1) / 27 / (5.7) / 55 / (11.6) / 46 / (5.8) / 96 / (12.2) / 0.0007 / 0.1790
Number of incidence / 208 / 637 / 102 / 372 / 34 / 70 / 61 / 173
Infections and infestations / 4 / (0.1) / 6 / (0.2) / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 2 / (0.3) / 4 / (0.5) / 0.2472 / 0.0357
Bronchitis / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Diabetic gangrene / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Diverticulitis / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Infection / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Pneumonia / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Urinary tract infection / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Puncture site abscess / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Neoplasms benign, malignant and unspecified (incl. cysts and polyps) / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 0 / 0 / 2 / (0.3) / 2 / (0.3) / 0.0535 / 0.0535
Tumour haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Small intestine carcinoma / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Blood and lymphatic system disorders / 9 / (0.2) / 36 / (0.9) / 1 / (0.0) / 19 / (0.7) / 1 / (0.2) / 2 / (0.4) / 6 / (0.8) / 14 / (1.8) / 0.0006 / 0.0168
Agranulocytosis / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Anaemia / 4 / (0.1) / 27 / (0.7) / 0 / 15 / (0.6) / 0 / 0 / 3 / (0.4) / 11 / (1.4)
Disseminated intravascular coagulation / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Granulocytopenia / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Iron deficiency anaemia / 2 / (0.1) / 4 / (0.1) / 0 / 1 / (0.0) / 1 / (0.2) / 2 / (0.4) / 1 / (0.1) / 1 / (0.1)
Leukopenia / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Pancytopenia / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Endocrine disorders / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / － / 1.0000
Hypothyroidism / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Metabolism and nutrition disorders / 2 / (0.1) / 15 / (0.4) / 1 / (0.0) / 9 / (0.3) / 1 / (0.2) / 1 / (0.2) / 0 / 5 / (0.6) / 0.2638 / 0.4406
Diabetes mellitus / 2 / (0.1) / 7 / (0.2) / 1 / (0.0) / 5 / (0.2) / 1 / (0.2) / 1 / (0.2) / 0 / 1 / (0.1)
Hypercholesterolaemia / 0 / 2 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 0 / 1 / (0.1)
Hypertriglyceridaemia / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Hyperuricaemia / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Decreased appetite / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Hyperlipidaemia / 0 / 4 / (0.1) / 0 / 2 / (0.1) / 0 / 0 / 0 / 2 / (0.3)
Hypo HDL cholesterolaemia / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Psychiatric disorders / 0 / 5 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 0 / 3 / (0.4) / － / 0.0360
Dysphoria / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 0
Insomnia / 0 / 3 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 0 / 2 / (0.3)
Anxiety disorder / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Nervous system disorders / 13 / (0.3) / 24 / (0.6) / 7 / (0.3) / 16 / (0.6) / 3 / (0.6) / 3 / (0.6) / 1 / (0.1) / 3 / (0.4) / 0.2413 / 0.7547
Brain stem haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Cerebral haemorrhage / 4 / (0.1) / 4 / (0.1) / 2 / (0.1) / 2 / (0.1) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Dizziness / 0 / 3 / (0.1) / 0 / 2 / (0.1) / 0 / 0 / 0 / 0
Dizziness postural / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Dysgeusia / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Headache / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Hepatic encephalopathy / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Hypoaesthesia / 0 / 5 / (0.1) / 0 / 5 / (0.2) / 0 / 0 / 0 / 0
Neuropathy peripheral / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Somnolence / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Subarachnoid haemorrhage / 4 / (0.1) / 4 / (0.1) / 2 / (0.1) / 2 / (0.1) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Thalamus haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Putamen haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Ischaemic cerebral infarction / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Eye disorders / 3 / (0.1) / 4 / (0.1) / 0 / 1 / (0.0) / 2 / (0.4) / 2 / (0.4) / 1 / (0.1) / 1 / (0.1) / 0.0179 / 0.0591
Eyelid ptosis / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Retinal artery embolism / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Vitreous haemorrhage / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 2 / (0.4) / 2 / (0.4) / 0 / 0
Ear and labyrinth disorders / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1) / － / 0.3177
Sudden hearing loss / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Cardiac disorders / 22 / (0.5) / 27 / (0.7) / 10 / (0.4) / 12 / (0.4) / 4 / (0.8) / 5 / (1.1) / 5 / (0.6) / 7 / (0.9) / 0.2148 / 0.1111
Acute myocardial infarction / 5 / (0.1) / 5 / (0.1) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 2 / (0.3) / 2 / (0.3)
Angina pectoris / 8 / (0.2) / 9 / (0.2) / 6 / (0.2) / 7 / (0.3) / 1 / (0.2) / 1 / (0.2) / 1 / (0.1) / 1 / (0.1)
Atrial fibrillation / 0 / 2 / (0.1) / 0 / 0 / 0 / 0 / 0 / 2 / (0.3)
Cardiac arrest / 2 / (0.1) / 2 / (0.1) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Cardiac failure / 3 / (0.1) / 3 / (0.1) / 0 / 0 / 2 / (0.4) / 2 / (0.4) / 0 / 0
Cardiogenic shock / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Interventricular septum rupture / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Ventricular tachycardia / 1 / (0.0) / 3 / (0.1) / 1 / (0.0) / 2 / (0.1) / 0 / 1 / (0.2) / 0 / 0
Intracardiac thrombus / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Bradyarrhythmia / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Haemorrhage coronary artery / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Vascular disorders / 6 / (0.2) / 20 / (0.5) / 2 / (0.1) / 15 / (0.6) / 2 / (0.4) / 3 / (0.6) / 2 / (0.3) / 2 / (0.3) / 0.0700 / 0.5345
Aortic dissection / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Haematoma / 2 / (0.1) / 2 / (0.1) / 1 / (0.0) / 1 / (0.0) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Hypertension / 0 / 10 / (0.3) / 0 / 9 / (0.3) / 0 / 1 / (0.2) / 0 / 0
Orthostatic hypotension / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Haemorrhage / 1 / (0.0) / 3 / (0.1) / 1 / (0.0) / 3 / (0.1) / 0 / 0 / 0 / 0
Peripheral arterial occlusive disease / 2 / (0.1) / 3 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 2 / (0.3) / 2 / (0.3)
Respiratory, thoracic and mediastinal disorders / 8 / (0.2) / 20 / (0.5) / 3 / (0.1) / 11 / (0.4) / 1 / (0.2) / 3 / (0.6) / 4 / (0.5) / 5 / (0.6) / 0.0700 / 0.5127
Cough / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Epistaxis / 0 / 8 / (0.2) / 0 / 4 / (0.2) / 0 / 2 / (0.4) / 0 / 1 / (0.1)
Haemoptysis / 1 / (0.0) / 4 / (0.1) / 1 / (0.0) / 4 / (0.2) / 0 / 0 / 0 / 0
Interstitial lung disease / 3 / (0.1) / 3 / (0.1) / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Pulmonary alveolar haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Pulmonary embolism / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Respiratory tract haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Bronchial haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Gastrointestinal disorders / 39 / (1.0) / 82 / (2.0) / 22 / (0.8) / 50 / (1.9) / 9 / (1.9) / 12 / (2.5) / 7 / (0.9) / 18 / (2.3) / 0.0924 / 0.4510
Colitis ischaemic / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Constipation / 0 / 10 / (0.3) / 0 / 5 / (0.2) / 0 / 1 / (0.2) / 0 / 4 / (0.5)
Diarrhoea / 1 / (0.0) / 4 / (0.1) / 1 / (0.0) / 2 / (0.1) / 0 / 1 / (0.2) / 0 / 1 / (0.1)
Diverticulum intestinal haemorrhagic / 6 / (0.2) / 6 / (0.2) / 5 / (0.2) / 5 / (0.2) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Duodenal ulcer / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Duodenal ulcer haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Dyspepsia / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Eructation / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Gastric haemorrhage / 4 / (0.1) / 6 / (0.2) / 3 / (0.1) / 4 / (0.2) / 1 / (0.2) / 2 / (0.4) / 0 / 0
Gastric ulcer haemorrhage / 7 / (0.2) / 9 / (0.2) / 3 / (0.1) / 4 / (0.2) / 3 / (0.6) / 3 / (0.6) / 1 / (0.1) / 2 / (0.3)
Gastritis / 0 / 3 / (0.1) / 0 / 3 / (0.1) / 0 / 0 / 0 / 0
Gastritis atrophic / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Gastrooesophageal reflux disease / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Gastrointestinal haemorrhage / 6 / (0.2) / 9 / (0.2) / 3 / (0.1) / 5 / (0.2) / 1 / (0.2) / 1 / (0.2) / 1 / (0.1) / 2 / (0.3)
Gingival bleeding / 0 / 4 / (0.1) / 0 / 4 / (0.2) / 0 / 0 / 0 / 0
Gingival hyperplasia / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Mouth haemorrhage / 1 / (0.0) / 2 / (0.1) / 0 / 0 / 0 / 0 / 1 / (0.1) / 2 / (0.3)
Nausea / 1 / (0.0) / 5 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 1 / (0.1) / 3 / (0.4)
Oesophageal haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Peptic ulcer / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Rectal haemorrhage / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Rectal ulcer haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Retroperitoneal haemorrhage / 2 / (0.1) / 2 / (0.1) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Stomatitis / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Vomiting / 1 / (0.0) / 3 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 1 / (0.1) / 2 / (0.3)
Lower gastrointestinal haemorrhage / 1 / (0.0) / 2 / (0.1) / 1 / (0.0) / 2 / (0.1) / 0 / 0 / 0 / 0
Large intestinal haemorrhage / 3 / (0.1) / 4 / (0.1) / 2 / (0.1) / 3 / (0.1) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Small intestinal haemorrhage / 2 / (0.1) / 2 / (0.1) / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 0 / 0
Haemorrhoidal haemorrhage / 0 / 2 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 0 / 1 / (0.1)
Retroperitoneal haematoma / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Abdominal wall haematoma / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Bloody peritoneal effluent / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Intestinal polyp haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Hepatobiliary disorders / 21 / (0.5) / 77 / (1.9) / 11 / (0.4) / 50 / (1.9) / 0 / 5 / (1.1) / 9 / (1.1) / 21 / (2.7) / 0.0116 / 0.1224
Cholangitis / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Hepatic cirrhosis / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 0
Hepatic congestion / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 0
Hepatic function abnormal / 16 / (0.4) / 51 / (1.3) / 8 / (0.3) / 31 / (1.1) / 0 / 5 / (1.1) / 8 / (1.0) / 15 / (1.9)
Liver disorder / 3 / (0.1) / 24 / (0.6) / 2 / (0.1) / 18 / (0.7) / 0 / 0 / 1 / (0.1) / 6 / (0.8)
Skin and subcutaneous tissue disorders / 11 / (0.3) / 52 / (1.3) / 4 / (0.2) / 33 / (1.2) / 2 / (0.4) / 5 / (1.1) / 4 / (0.5) / 13 / (1.7) / 0.0994 / 0.5940
Alopecia / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Drug eruption / 3 / (0.1) / 6 / (0.2) / 1 / (0.0) / 4 / (0.2) / 0 / 0 / 2 / (0.3) / 2 / (0.3)
Eczema / 0 / 2 / (0.1) / 0 / 2 / (0.1) / 0 / 0 / 0 / 0
Erythema / 0 / 2 / (0.1) / 0 / 0 / 0 / 1 / (0.2) / 0 / 1 / (0.1)
Erythema multiforme / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Haemorrhage subcutaneous / 1 / (0.0) / 5 / (0.1) / 0 / 3 / (0.1) / 0 / 0 / 1 / (0.1) / 2 / (0.3)
Pruritus / 0 / 5 / (0.1) / 0 / 1 / (0.0) / 0 / 2 / (0.4) / 0 / 2 / (0.3)
Purpura / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Pustular psoriasis / 0 / 2 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 0 / 1 / (0.1)
Rash / 4 / (0.1) / 19 / (0.5) / 2 / (0.1) / 15 / (0.6) / 1 / (0.2) / 1 / (0.2) / 0 / 2 / (0.3)
Rash generalised / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 1 / (0.1) / 1 / (0.1)
Rash maculo-papular / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Rash papular / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Urticaria / 0 / 6 / (0.2) / 0 / 3 / (0.1) / 0 / 1 / (0.2) / 0 / 2 / (0.3)
Musculoskeletal and connective tissue disorders / 0 / 3 / (0.1) / 0 / 1 / (0.0) / 0 / 1 / (0.2) / 0 / 1 / (0.1) / － / 0.2386
Arthritis / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Back pain / 0 / 2 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 0 / 1 / (0.1)
Pain in extremity / 0 / 1 / (0.0) / 0 / 0 / 0 / 1 / (0.2) / 0 / 0
Renal and urinary disorders / 4 / (0.1) / 11 / (0.3) / 1 / (0.0) / 6 / (0.2) / 0 / 1 / (0.2) / 3 / (0.4) / 4 / (0.5) / 0.0360 / 0.3507
Haematuria / 0 / 3 / (0.1) / 0 / 1 / (0.0) / 0 / 1 / (0.2) / 0 / 1 / (0.1)
Renal disorder / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Renal failure / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 0 / 0 / 2 / (0.3) / 2 / (0.3)
Urinary bladder haemorrhage / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Urethral haemorrhage / 1 / (0.0) / 2 / (0.1) / 1 / (0.0) / 2 / (0.1) / 0 / 0 / 0 / 0
Renal impairment / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Prerenal failure / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Reproductive system and breast disorders / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1.0000 / 1.0000
Prostatic haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
General disorders and administration site conditions / 26 / (0.6) / 39 / (1.0) / 14 / (0.5) / 21 / (0.8) / 5 / (1.1) / 10 / (2.1) / 6 / (0.8) / 7 / (0.9) / 0.2653 / 0.0380
Chest pain / 1 / (0.0) / 2 / (0.1) / 0 / 1 / (0.0) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Death / 4 / (0.1) / 4 / (0.1) / 2 / (0.1) / 2 / (0.1) / 2 / (0.4) / 2 / (0.4) / 0 / 0
Drowning / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Multi-organ failure / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Oedema peripheral / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Pyrexia / 2 / (0.1) / 4 / (0.1) / 1 / (0.0) / 2 / (0.1) / 0 / 1 / (0.2) / 1 / (0.1) / 1 / (0.1)
Sudden death / 4 / (0.1) / 4 / (0.1) / 3 / (0.1) / 3 / (0.1) / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Cardiac death / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Catheter site haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Puncture site haemorrhage / 6 / (0.2) / 13 / (0.3) / 2 / (0.1) / 7 / (0.3) / 2 / (0.4) / 4 / (0.8) / 2 / (0.3) / 2 / (0.3)
Vessel puncture site haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Thrombosis in device / 3 / (0.1) / 3 / (0.1) / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 0 / 0
Vessel puncture site haematoma / 2 / (0.1) / 4 / (0.1) / 2 / (0.1) / 2 / (0.1) / 0 / 2 / (0.4) / 0 / 0
Investigations / 9 / (0.2) / 98 / (2.4) / 6 / (0.2) / 64 / (2.4) / 0 / 8 / (1.7) / 3 / (0.4) / 23 / (2.9) / 0.4402 / 0.3836
Alanine aminotransferase increased / 1 / (0.0) / 15 / (0.4) / 1 / (0.0) / 12 / (0.4) / 0 / 0 / 0 / 2 / (0.3)
Aspartate aminotransferase increased / 1 / (0.0) / 10 / (0.3) / 1 / (0.0) / 8 / (0.3) / 0 / 0 / 0 / 2 / (0.3)
Blood bilirubin increased / 1 / (0.0) / 3 / (0.1) / 1 / (0.0) / 3 / (0.1) / 0 / 0 / 0 / 0
Blood cholesterol increased / 0 / 2 / (0.1) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Blood creatine phosphokinase increased / 0 / 1 / (0.0) / 0 / 0 / 0 / 1 / (0.2) / 0 / 0
Blood creatinine increased / 0 / 9 / (0.2) / 0 / 2 / (0.1) / 0 / 0 / 0 / 6 / (0.8)
Blood glucose increased / 0 / 2 / (0.1) / 0 / 1 / (0.0) / 0 / 1 / (0.2) / 0 / 0
Blood pressure increased / 0 / 5 / (0.1) / 0 / 3 / (0.1) / 0 / 0 / 0 / 2 / (0.3)
Blood triglycerides increased / 0 / 11 / (0.3) / 0 / 8 / (0.3) / 0 / 1 / (0.2) / 0 / 2 / (0.3)
Blood urea decreased / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Blood urea increased / 0 / 6 / (0.2) / 0 / 2 / (0.1) / 0 / 0 / 0 / 4 / (0.5)
Gamma-glutamyltransferase increased / 0 / 17 / (0.4) / 0 / 13 / (0.5) / 0 / 2 / (0.4) / 0 / 1 / (0.1)
Glycosylated haemoglobin increased / 0 / 7 / (0.2) / 0 / 2 / (0.1) / 0 / 2 / (0.4) / 0 / 3 / (0.4)
Haematocrit decreased / 0 / 5 / (0.1) / 0 / 2 / (0.1) / 0 / 0 / 0 / 3 / (0.4)
Haemoglobin decreased / 1 / (0.0) / 8 / (0.2) / 1 / (0.0) / 3 / (0.1) / 0 / 0 / 0 / 5 / (0.6)
High density lipoprotein decreased / 0 / 5 / (0.1) / 0 / 4 / (0.2) / 0 / 0 / 0 / 1 / (0.1)
Liver function test abnormal / 3 / (0.1) / 6 / (0.2) / 1 / (0.0) / 3 / (0.1) / 0 / 0 / 2 / (0.3) / 3 / (0.4)
Low density lipoprotein increased / 0 / 2 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 0 / 1 / (0.1)
Neutrophil count decreased / 1 / (0.0) / 4 / (0.1) / 1 / (0.0) / 3 / (0.1) / 0 / 0 / 0 / 1 / (0.1)
Platelet count decreased / 0 / 14 / (0.4) / 0 / 10 / (0.4) / 0 / 1 / (0.2) / 0 / 3 / (0.4)
Red blood cell count decreased / 1 / (0.0) / 3 / (0.1) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 2 / (0.3)
White blood cell count decreased / 1 / (0.0) / 12 / (0.3) / 1 / (0.0) / 9 / (0.3) / 0 / 0 / 0 / 2 / (0.3)
White blood cell count increased / 0 / 2 / (0.1) / 0 / 2 / (0.1) / 0 / 0 / 0 / 0
Platelet count increased / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Blood alkaline phosphatase increased / 0 / 11 / (0.3) / 0 / 7 / (0.3) / 0 / 2 / (0.4) / 0 / 2 / (0.3)
Hepatic enzyme increased / 1 / (0.0) / 4 / (0.1) / 0 / 2 / (0.1) / 0 / 1 / (0.2) / 1 / (0.1) / 1 / (0.1)
Renal function test abnormal / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Hepatic enzyme abnormal / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Injury, poisoning and procedural complications / 18 / (0.4) / 23 / (0.6) / 10 / (0.4) / 11 / (0.4) / 4 / (0.8) / 5 / (1.1) / 4 / (0.5) / 5 / (0.6) / 0.2871 / 0.1396
Fall / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Subcutaneous haematoma / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 0
Subdural haematoma / 4 / (0.1) / 4 / (0.1) / 3 / (0.1) / 3 / (0.1) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Subdural haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Traumatic haematoma / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 0
Vascular pseudoaneurysm / 2 / (0.1) / 2 / (0.1) / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 0 / 0
Post procedural haemorrhage / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Traumatic haemorrhage / 1 / (0.0) / 2 / (0.1) / 0 / 0 / 0 / 1 / (0.2) / 1 / (0.1) / 1 / (0.1)
Vascular pseudoaneurysm ruptured / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Coronary artery restenosis / 5 / (0.1) / 5 / (0.1) / 3 / (0.1) / 3 / (0.1) / 1 / (0.2) / 1 / (0.2) / 1 / (0.1) / 1 / (0.1)
Traumatic intracranial haemorrhage / 2 / (0.1) / 2 / (0.1) / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 0 / 0
Tracheal haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Procedural haemorrhage / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)

a Fisher’s exact test

Supplementary table2. Incidence of bleeding adverse event for one year by group, n (%)

Total
(n=4049) / NSTE-ACS
(n=2708) / SA/OMI
(n=474) / STEMI
(n=787) / P valuea
Serious / Total / Serious / Total / Serious / Total / Serious / Total / Serious / Total
Number of Patients with events / 93 / (2.3) / 154 / (3.8) / 54 / (2.0) / 94 / (3.5) / 18 / (3.8) / 28 / (5.9) / 18 / (2.3) / 28 / (3.6) / 0.0622 / 0.0437
Number of incidence / 100 / 166 / 58 / 99 / 19 / 30 / 19 / 30
Neoplasms benign, malignant and unspecified (incl. cysts and polyps) / 2 / (0.1) / 2 / (0.1) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.1) / 1 / (0.1) / 0.5345 / 0.5345
Tumour haemorrhage / 2 / (0.1) / 2 / (0.1) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Blood and lymphatic system disorders / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1) / － / 0.3177
Haemorrhagic anaemia / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)
Nervous system disorders / 13 / (0.3) / 13 / (0.3) / 8 / (0.3) / 8 / (0.3) / 2 / (0.4) / 2 / (0.4) / 1 / (0.1) / 1 / (0.1) / 0.5764 / 0.5764
Brain stem haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Cerebral haemorrhage / 5 / (0.1) / 5 / (0.1) / 3 / (0.1) / 3 / (0.1) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Subarachnoid haemorrhage / 5 / (0.1) / 5 / (0.1) / 3 / (0.1) / 3 / (0.1) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Thalamus haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Putamen haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Eye disorders / 2 / (0.1) / 4 / (0.1) / 0 / 1 / (0.0) / 2 / (0.4) / 3 / (0.6) / 0 / 0 / 0.0142 / 0.0147
Conjunctival haemorrhage / 0 / 1 / (0.0) / 0 / 0 / 0 / 1 / (0.2) / 0 / 0
Retinal haemorrhage / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Vitreous haemorrhage / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 2 / (0.4) / 2 / (0.4) / 0 / 0
Cardiac disorders / 4 / (0.1) / 4 / (0.1) / 3 / (0.1) / 3 / (0.1) / 0 / 0 / 1 / (0.1) / 1 / (0.1) / 1.0000 / 1.0000
Pericardial haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Haemorrhage coronary artery / 2 / (0.1) / 2 / (0.1) / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 0 / 0
Coronary artery perforation / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Vascular disorders / 4 / (0.1) / 6 / (0.2) / 2 / (0.1) / 4 / (0.2) / 1 / (0.2) / 1 / (0.2) / 1 / (0.1) / 1 / (0.1) / 0.3796 / 0.8240
Haematoma / 2 / (0.1) / 2 / (0.1) / 1 / (0.0) / 1 / (0.0) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Haemorrhage / 2 / (0.1) / 4 / (0.1) / 1 / (0.0) / 3 / (0.1) / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Respiratory, thoracic and mediastinal disorders / 5 / (0.1) / 17 / (0.4) / 2 / (0.1) / 9 / (0.3) / 1 / (0.2) / 3 / (0.6) / 2 / (0.3) / 4 / (0.5) / 0.2324 / 0.4936
Epistaxis / 0 / 8 / (0.2) / 0 / 4 / (0.2) / 0 / 2 / (0.4) / 0 / 1 / (0.1)
Haemoptysis / 2 / (0.1) / 6 / (0.2) / 2 / (0.1) / 5 / (0.2) / 0 / 0 / 0 / 1 / (0.1)
Pulmonary alveolar haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Respiratory tract haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Bronchial haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Gastrointestinal disorders / 40 / (1.0) / 61 / (1.5) / 24 / (0.9) / 39 / (1.4) / 9 / (1.9) / 11 / (2.3) / 6 / (0.8) / 10 / (1.3) / 0.1106 / 0.3036
Diverticulum intestinal haemorrhagic / 6 / (0.2) / 6 / (0.2) / 5 / (0.2) / 5 / (0.2) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Duodenal ulcer haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Gastric haemorrhage / 4 / (0.1) / 6 / (0.2) / 3 / (0.1) / 4 / (0.2) / 1 / (0.2) / 2 / (0.4) / 0 / 0
Gastric ulcer haemorrhage / 7 / (0.2) / 10 / (0.3) / 3 / (0.1) / 4 / (0.2) / 3 / (0.6) / 4 / (0.8) / 1 / (0.1) / 2 / (0.3)
Gastrointestinal haemorrhage / 6 / (0.2) / 9 / (0.2) / 3 / (0.1) / 5 / (0.2) / 1 / (0.2) / 1 / (0.2) / 1 / (0.1) / 2 / (0.3)
Gingival bleeding / 0 / 4 / (0.1) / 0 / 4 / (0.2) / 0 / 0 / 0 / 0
Mallory-Weiss syndrome / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Mouth haemorrhage / 1 / (0.0) / 2 / (0.1) / 0 / 0 / 0 / 0 / 1 / (0.1) / 2 / (0.3)
Oesophageal haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Oesophageal varices haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Rectal haemorrhage / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Rectal ulcer haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Retroperitoneal haemorrhage / 2 / (0.1) / 2 / (0.1) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Lower gastrointestinal haemorrhage / 1 / (0.0) / 2 / (0.1) / 1 / (0.0) / 2 / (0.1) / 0 / 0 / 0 / 0
Large intestinal haemorrhage / 3 / (0.1) / 4 / (0.1) / 2 / (0.1) / 3 / (0.1) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Small intestinal haemorrhage / 4 / (0.1) / 4 / (0.1) / 3 / (0.1) / 3 / (0.1) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Haemorrhoidal haemorrhage / 0 / 3 / (0.1) / 0 / 2 / (0.1) / 0 / 0 / 0 / 1 / (0.1)
Retroperitoneal haematoma / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Abdominal wall haematoma / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Bloody peritoneal effluent / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Intestinal polyp haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Hepatobiliary disorders / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1.0000 / 1.0000
Hepatic haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
Skin and subcutaneous tissue disorders / 1 / (0.0) / 6 / (0.2) / 0 / 4 / (0.2) / 0 / 0 / 1 / (0.1) / 2 / (0.3) / 0.3177 / 0.6698
Haemorrhage subcutaneous / 1 / (0.0) / 5 / (0.1) / 0 / 3 / (0.1) / 0 / 0 / 1 / (0.1) / 2 / (0.3)
Purpura / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Renal and urinary disorders / 1 / (0.0) / 6 / (0.2) / 1 / (0.0) / 4 / (0.2) / 0 / 1 / (0.2) / 0 / 1 / (0.1) / 1.0000 / 0.8240
Haematuria / 0 / 3 / (0.1) / 0 / 1 / (0.0) / 0 / 1 / (0.2) / 0 / 1 / (0.1)
Urinary bladder haemorrhage / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Urethral haemorrhage / 1 / (0.0) / 2 / (0.1) / 1 / (0.0) / 2 / (0.1) / 0 / 0 / 0 / 0
Reproductive system and breast disorders / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1.0000 / 1.0000
Prostatic haemorrhage / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0
General disorders and administration site conditions / 12 / (0.3) / 24 / (0.6) / 7 / (0.3) / 14 / (0.5) / 2 / (0.4) / 6 / (1.3) / 3 / (0.4) / 4 / (0.5) / 0.6669 / 0.1709
Catheter site haemorrhage / 1 / (0.0) / 3 / (0.1) / 0 / 1 / (0.0) / 0 / 0 / 1 / (0.1) / 2 / (0.3)
Puncture site haemorrhage / 6 / (0.2) / 14 / (0.4) / 2 / (0.1) / 8 / (0.3) / 2 / (0.4) / 4 / (0.8) / 2 / (0.3) / 2 / (0.3)
Vessel puncture site haemorrhage / 2 / (0.1) / 2 / (0.1) / 2 / (0.1) / 2 / (0.1) / 0 / 0 / 0 / 0
Vessel puncture site haematoma / 3 / (0.1) / 5 / (0.1) / 3 / (0.1) / 3 / (0.1) / 0 / 2 / (0.4) / 0 / 0
Injury, poisoning and procedural complications / 13 / (0.3) / 19 / (0.5) / 7 / (0.3) / 9 / (0.3) / 2 / (0.4) / 3 / (0.6) / 3 / (0.4) / 4 / (0.5) / 0.6669 / 0.4936
Haematuria traumatic / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Subcutaneous haematoma / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 0
Subdural haematoma / 5 / (0.1) / 5 / (0.1) / 4 / (0.2) / 4 / (0.2) / 1 / (0.2) / 1 / (0.2) / 0 / 0
Subdural haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 1 / (0.2) / 1 / (0.2) / 0 / 0
Traumatic haematoma / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 0
Post procedural haemorrhage / 0 / 1 / (0.0) / 0 / 1 / (0.0) / 0 / 0 / 0 / 0
Wound / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 0
Traumatic haemorrhage / 1 / (0.0) / 2 / (0.1) / 0 / 0 / 0 / 1 / (0.2) / 1 / (0.1) / 1 / (0.1)
Vascular pseudoaneurysm ruptured / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Traumatic intracranial haemorrhage / 3 / (0.1) / 3 / (0.1) / 3 / (0.1) / 3 / (0.1) / 0 / 0 / 0 / 0
Tracheal haemorrhage / 1 / (0.0) / 1 / (0.0) / 0 / 0 / 0 / 0 / 1 / (0.1) / 1 / (0.1)
Procedural haemorrhage / 0 / 1 / (0.0) / 0 / 0 / 0 / 0 / 0 / 1 / (0.1)

aFisher’s exact test

Supplementary table3. Incidence of serious bleeding adverse events by baseline factors in each group, n(%)

Total / NSTE-ACS / SA/OMI / STEMI
Number of patients, / Patients with serious bleeding AEa / P valueb / Number of patients, / Patients with serious bleeding AEa / P valueb / Number of patients / Patients with serious bleeding AEa / P valueb / Number of patients / Patients with serious bleeding AEa / P valueb
Total / 4049 / 93 / (2.3) / － / 2708 / 54 / (2.0) / － / 474 / 18 / (3.8) / － / 787 / 18 / (2.3) / －
Sex
Male / 2928 / 57 / (2.0) / 0.0189 / 1953 / 36 / (1.8) / 0.3607 / 323 / 10 / (3.1) / 0.3017 / 595 / 8 / (1.3) / 0.0039
Female / 1120 / 36 / (3.2) / 755 / 18 / (2.4) / 151 / 8 / (5.3) / 191 / 10 / (5.2)
Not pregnant / 1120 / 36 / (3.2) / － / 755 / 18 / (2.4) / － / 151 / 8 / (5.3) / － / 191 / 10 / (5.2) / －
Pregnant / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0
Age
<15 / 0 / 0 / 0.0001 / 0 / 0 / 0.0001 / 0 / 0 / 0.0004 / 0 / 0 / 0.0217
≥15 to <65 / 1411 / 12 / (0.9) / 923 / 7 / (0.8) / 134 / 1 / (0.8) / 333 / 3 / (0.9)
≥65-to<75 / 1295 / 20 / (1.5) / 874 / 11 / (1.3) / 172 / 3 / (1.7) / 225 / 6 / (2.7)
≥75 / 1338 / 61 / (4.6) / 910 / 36 / (4.0) / 168 / 14 / (8.3) / 225 / 9 / (4.0)
Body weight (kg)
≤50 / 717 / 35 / (4.9) / 0.0001 / 494 / 21 / (4.3) / 0.0004 / 77 / 8 / (10.4) / 0.0041 / 130 / 6 / (4.6) / 0.1012
>50 / 3289 / 58 / (1.8) / 2197 / 33 / (1.5) / 391 / 10 / (2.6) / 638 / 12 / (1.9)
BMI (kg/m2)
<18.5 / 187 / 10 / (5.4) / 0.0050 / 130 / 9 / (6.9) / 0.0003 / 14 / 0 / 1.0000 / 38 / 1 / (2.6) / 1.0000
≥18.5 to<25 / 2452 / 60 / (2.5) / 1625 / 34 / (2.1) / 299 / 13 / (4.4) / 470 / 10 / (2.1)
≥25 / 1352 / 22 / (1.6) / 929 / 11 / (1.2) / 154 / 5 / (3.3) / 254 / 6 / (2.4)
Ejection fraction
<55 / 1057 / 32 / (3.0) / 0.1203 / 571 / 18 / (3.2) / 0.0626 / 113 / 4 / (3.5) / 1.0000 / 343 / 8 / (2.3) / 1.0000
≥55 / 2420 / 52 / (2.2) / 1763 / 31 / (1.8) / 317 / 13 / (4.1) / 296 / 7 / (2.4)
Recent chest pain
At rest / 2173 / 56 / (2.6) / 0.3134 / 1505 / 35 / (2.3) / 0.1053 / 90 / 5 / (5.6) / 0.7710 / 566 / 15 / (2.7) / 1.0000
On exertion / 1439 / 29 / (2.0) / 1035 / 14 / (1.4) / 253 / 11 / (4.4) / 143 / 3 / (2.1)
Electrocardiogram findingsc
Ischemia not found / 928 / 21 / (2.3) / － / 692 / 13 / (1.9) / － / 203 / 6 / (3.0) / － / 5 / 1 / (20.0) / －
ST-segment elevation / 1010 / 21 / (2.1) / 227 / 3 / (1.3) / 25 / 1 / (4.0) / 750 / 16 / (2.1)
ST-segment depression / 1294 / 33 / (2.6) / 1115 / 26 / (2.3) / 109 / 4 / (3.7) / 51 / 2 / (3.9)
T-wave inversion / 905 / 14 / (1.6) / 752 / 10 / (1.3) / 95 / 4 / (4.2) / 38 / 0
New abnormal Q wave / 226 / 9 / (4.0) / 131 / 3 / (2.3) / 31 / 2 / (6.5) / 57 / 3 / (5.3)
Left bundle branch block / 34 / 1 / (2.9) / 23 / 1 / (4.4) / 6 / 0 / 3 / 0
Others / 267 / 7 / (2.6) / 177 / 4 / (2.3) / 50 / 2 / (4.0) / 22 / 0
Comorbidity
Absent / 180 / 2 (1.1) / 0.4408 / 115 / 1 (0.9) / 0.7277 / 13 / 0 / 1.0000 / 50 / 1 (2.0) / 1.0000
Present / 3851 / 91 (2.4) / 2585 / 53 (2.1) / 457 / 18 (3.9) / 731 / 17 (2.3)
Hypertension
Absent / 1066 / 20 (1.9) / 0.3409 / 694 / 9 (1.3) / 0.1560 / 109 / 5 (4.6) / 0.5798 / 243 / 6 (2.5) / 0.8015
Present / 2965 / 73 (2.5) / 2006 / 45 (2.2) / 361 / 13 (3.6) / 538 / 12 (2.2)
Dyslipidemia
Absent / 1298 / 41 (3.2) / 0.0178 / 855 / 23 (2.7) / 0.1028 / 129 / 9 (7.0) / 0.0544 / 281 / 7 (2.5) / 0.8070
Present / 2733 / 52 (1.9) / 1845 / 31 (1.7) / 341 / 9 (2.6) / 500 / 11 (2.2)
Diabetes mellitus
Absent / 2633 / 61 (2.3) / 1.0000 / 1788 / 37 (2.1) / 0.7730 / 275 / 12 (4.4) / 0.6272 / 531 / 10 (1.9) / 0.3065
Present / 1398 / 32 (2.3) / 912 / 17 (1.9) / 195 / 6 (3.1) / 250 / 8 (3.2)
Peripheral arterial diseased
Absent / 3732 / 83 (2.2) / 0.2851 / 2518 / 48 (1.9) / 0.1597 / 416 / 17 (4.1) / 1.0000 / 732 / 15 (2.1) / 0.2949
Present / 171 / 6 (3.5) / 107 / 4 (3.7) / 37 / 1 (2.7) / 16 / 1 (6.3)
Arrhythmia
Absent / 3623 / 73 (2.0) / 0.0012 / 2429 / 43 (1.8) / 0.0191 / 423 / 14 (3.3) / 0.0942 / 706 / 15 (2.1) / 0.4042
Present / 408 / 20 (4.9) / 271 / 11 (4.1) / 47 / 4 (8.5) / 75 / 3 (4.0)
Atrial fibrillation
Absent / 3778 / 76 (2.0) / 0.0004 / 2526 / 44 (1.7) / 0.0155 / 441 / 15 (3.4) / 0.1223 / 744 / 16 (2.2) / 0.2162
Present / 254 / 15 (5.9) / 172 / 8 (4.7) / 33 / 3 (9.1) / 38 / 2 (5.3)
Liver dysfunction
Absent / 3900 / 86 (2.2) / 0.0304 / 2611 / 49 (1.9) / 0.0308 / 455 / 18 (4.0) / 1.0000 / 757 / 17 (2.3) / 0.4334
Present / 131 / 7 (5.3) / 89 / 5 (5.6) / 15 / 0 / 24 / 1 (4.2)
Renal disorder
Absent / 3686 / 84 (2.3) / 0.7059 / 2471 / 48 (1.9) / 0.4564 / 426 / 17 (4.0) / 1.0000 / 726 / 17 (2.3) / 1.0000
Present / 345 / 9 (2.6) / 229 / 6 (2.6) / 44 / 1 (2.3) / 55 / 1 (1.8)
ALT and/or AST (institutional criteria)
ALT and AST = institutional criteria / 1548 / 35 (2.3) / 1.0000 / 1083 / 29 (2.7) / 0.2663 / 201 / 2 (1.0) / 1.0000 / 217 / 2 (0.9) / 0.1760
ALT and/or AST ≠institutional criteria / 707 / 15 (2.1) / 427 / 7 (1.6) / 47 / 0 / 226 / 7 (3.1)
ALT and/or AST (criteria of ≥50U/L)
ALT and AST <50 / 2998 / 70 (2.3) / 0.6005 / 2085 / 44 (2.1) / 1.0000 / 387 / 16 (4.1) / 1.0000 / 456 / 8 (1.8) / 0.2204
ALT and/or AST ≥50 / 785 / 21 (2.7) / 438 / 9 (2.1) / 45 / 1 (2.2) / 294 / 10 (3.4)
ALT and/or AST (criteria of ≥100U/L)
ALT and AST <100 / 3468 / 83 (2.4) / 0.8467 / 2383 / 52 (2.2) / 0.3643 / 421 / 17 (4.0) / 1.0000 / 589 / 11 (1.9) / 0.0799
ALT and/or AST ≥100 / 314 / 8 (2.6) / 140 / 1 (0.7) / 11 / 0 / 160 / 7 (4.4)
eGFR(criteria of 60)
eGFR ≥60 / 2482 / 40 (1.6) / <0.0001 / 1662 / 26 (1.6) / 0.0127 / 274 / 6 (2.2) / 0.0124 / 512 / 7 (1.4) / 0.0094
eGFR 60 / 1316 / 52 (4.0) / 871 / 27 (3.1) / 165 / 12 (7.3) / 236 / 11 (4.7)
Hemorrhagic diathesis
Absent / 4017 / 90 (2.2) / 0.0035 / 2691 / 53 (2.0) / 0.1664 / 470 / 18 (3.8) / － / 776 / 16 (2.1) / 0.0048
Present / 14 / 3 (21.4) / 9 / 1 (11.1) / 0 / 0 / 5 / 2 (40.0)
Others
Absent / 2382 / 42 (1.8) / 0.0073 / 1607 / 19 (1.2) / 0.0003 / 252 / 13 (5.2) / 0.1475 / 486 / 10 (2.1) / 0.6251
Present / 1649 / 51 (3.1) / 1093 / 35 (3.2) / 218 / 5 (2.3) / 295 / 8 (2.7)
History of bleeding
Absent / 3859 / 85 (2.2) / 0.0184 / 2597 / 51 (2.0) / 0.4305 / 448 / 18 (4.0) / 1.0000 / 738 / 13 (1.8) / 0.0006
Present / 45 / 4 (8.9) / 28 / 1 (3.6) / 7 / 0 / 9 / 3 (33.3)
Prior use of antiplatelet agents
Absent / 2552 / 42 (1.7) / 0.0004 / 1649 / 23 (1.4) / 0.0070 / 193 / 5 (2.6) / 0.3309 / 684 / 13 (1.9) / 0.0737
Present / 1497 / 51 (3.4) / 1059 / 31 (2.9) / 281 / 13 (4.6) / 103 / 5 (4.9)
Prior use of aspirin
Absent / 2633 / 44 (1.7) / 0.0004 / 1699 / 25 (1.5) / 0.0150 / 207 / 5 (2.4) / 0.2264 / 698 / 13 (1.9) / 0.0429
Present / 1416 / 49 (3.5) / 1009 / 29 (2.9) / 267 / 13 (4.9) / 89 / 5 (5.6)
Clopidogrel treatment duration (wk)
≤4 / 476 / 16 (3.4) / 0.0025 / 304 / 9 (3.0) / 0.0015 / 33 / 0 / 1.0000 / 130 / 6 (4.6) / 0.2993
5-8 / 299 / 9 (3.0) / 192 / 8 (4.2) / 26 / 0 / 79 / 1 (1.3)
9-12 / 149 / 5 (3.4) / 92 / 4 (4.4) / 12 / 1 (8.3) / 42 / 0
13-26 / 273 / 11 (4.0) / 183 / 5 (2.7) / 33 / 5 (15.2) / 51 / 1 (2.0)
27-52 / 634 / 16 (2.5) / 425 / 9 (2.1) / 78 / 4 (5.1) / 120 / 3 (2.5)
≥53 / 2218 / 36 (1.6) / 1512 / 19 (1.3) / 292 / 8 (2.7) / 365 / 7 (1.9)
Clopidogrel loading dose (mg)
None / 1304 / 29 (2.2) / 0.8664 / 898 / 17 (1.9) / 0.7757 / 270 / 10 (3.7) / 0.9674 / 95 / 1 (1.1) / 0.4414
<300 / 86 / 2 (2.3) / 64 / 1 (1.6) / 5 / 0 / 15 / 0
≥300 / 2658 / 62 (2.3) / 1745 / 36 (2.1) / 199 / 8 (4.0) / 677 / 17 (2.5)
Clopidogrel treatment discontinuation
None / 2329 / 40 (1.7) / 0.0339 / 1596 / 21 (1.3) / 0.0640 / 294 / 8 (2.7) / 0.0742 / 391 / 10 (2.6) / 0.5073
≤12 wk / 873 / 27 (3.1) / 557 / 19 (3.4) / 69 / 1 (1.5) / 234 / 6 (2.6)
13-26wk / 236 / 10 (4.2) / 158 / 5 (3.2) / 30 / 5 (16.7) / 44 / 0
≥27 wk / 611 / 16 (2.6) / 397 / 9 (2.3) / 81 / 4 (4.9) / 118 / 2 (1.7)
Concomitant medications
Absent / 5 / 0 / 1.0000 / 5 / 0 / 1.0000 / 0 / 0 / － / 0 / 0 / －
Present / 4044 / 93 (2.3) / 2703 / 54 (2.0) / 474 / 18 (3.8) / 787 / 18 (2.3)
Aspirin
Absent / 62 / 0 / 0.4037 / 50 / 0 / 0.6249 / 7 / 0 / 1.0000 / 3 / 0 / 1.0000
Present / 3987 / 93 (2.3) / 2658 / 54 (2.0) / 467 / 18 (3.9) / 784 / 18 (2.3)
Aspirin (≥30 days)
Absent / 566 / 19 (3.4) / 0.0648 / 378 / 11 (2.9) / 0.1668 / 39 / 0 / 0.3815 / 137 / 7 (5.1) / 0.0195
Present / 3245 / 67 (2.1) / 2166 / 40 (1.9) / 386 / 16 (4.2) / 633 / 10 (1.6)
Antiplatelet (other than aspirin)
Absent / 3603 / 83 (2.3) / 1.0000 / 2412 / 46 (1.9) / 0.3740 / 424 / 17 (4.0) / 0.7081 / 701 / 17 (2.4) / 0.7097
Present / 446 / 10 (2.2) / 296 / 8 (2.7) / 50 / 1 (2.0) / 86 / 1 (1.2)
Antiplatelet (other than aspirin) (≥30 days)
Absent / 3733 / 86 (2.3) / 1.0000 / 2494 / 49 (2.0) / 0.7466 / 432 / 17 (3.9) / 1.0000 / 737 / 17 (2.3) / 0.5600
Present / 194 / 4 (2.1) / 134 / 3 (2.2) / 19 / 0 / 34 / 1 (2.9)
Heparin
Absent / 1152 / 27 (2.3) / 0.9076 / 822 / 18 (2.2) / 0.6545 / 192 / 6 (3.1) / 0.6289 / 111 / 2 (1.8) / 1.0000
Present / 2897 / 66 (2.3) / 1886 / 36 (1.9) / 282 / 12 (4.3) / 676 / 16 (2.4)
Heparin (≥30 days)
Absent / 4018 / 91 (2.3) / 0.2765 / 2694 / 54 (2.0) / 1.0000 / 472 / 18 (3.8) / 1.0000 / 773 / 16 (2.1) / 0.1434
Present / 14 / 1 (7.1) / 6 / 0 / 1 / 0 / 7 / 1 (14.3)
Anticoagulants
Absent / 3770 / 72 (1.9) / <0.0001 / 2546 / 45 (1.8) / 0.0040 / 439 / 11 (2.5) / 0.0001 / 712 / 14 (2.0) / 0.0831
Present / 279 / 21 (7.5) / 162 / 9 (5.6) / 35 / 7 (20.0) / 75 / 4 (5.3)
Anticoagulants (≥30 days)
Absent / 3818 / 75 (2.0) / <0.0001 / 2573 / 47 (1.8) / 0.0093 / 441 / 11 (2.5) / 0.0005 / 730 / 15 (2.1) / 0.1068
Present / 170 / 14 (8.2) / 93 / 6 (6.5) / 23 / 5 (21.7) / 51 / 3 (5.9)
Aspirin and anticoagulants (≥30 days)
Absent / 3820 / 75 (2.0) / <0.0001 / 2574 / 47 (1.8) / 0.0089 / 442 / 11 (2.5) / 0.0004 / 730 / 15 (2.1) / 0.1068
Present / 168 / 14 (8.3) / 92 / 6 (6.5) / 22 / 5 (22.7) / 51 / 3 (5.9)
NSAID
Absent / 3815 / 87 (2.3) / 0.6566 / 2567 / 51 (2.0) / 0.7583 / 448 / 18 (4.0) / 0.6141 / 727 / 16 (2.2) / 0.6409
Present / 234 / 6 (2.6) / 141 / 3 (2.1) / 26 / 0 / 60 / 2 (3.3)
NSAID (≥30 days)
Absent / 3921 / 91 (2.3) / 1.0000 / 2629 / 53 (2.0) / 1.0000 / 459 / 18 (3.9) / 1.0000 / 758 / 18 (2.4) / 1.0000
Present / 40 / 0 / 22 / 0 / 6 / 0 / 9 / 0
Thrombolytic
Absent / 4041 / 92 (2.3) / 0.1697 / 2705 / 54 (2.0) / 1.0000 / 474 / 18 (3.8) / － / 782 / 17 (2.2) / 0.1095
Present / 8 / 1 (12.5) / 3 / 0 / 0 / 0 / 5 / 1 (20.0)
Others
Absent / 111 / 1 (0.9) / 0.5199 / 78 / 1 (1.3) / 1.0000 / 11 / 0 / 1.0000 / 21 / 0 / 1.0000
Present / 3938 / 92 (2.3) / 2630 / 53 (2.0) / 463 / 18 (3.9) / 766 / 18 (2.4)
PPI
Absent / 2157 / 37 (1.7) / 0.0086 / 1527 / 20 (1.3) / 0.0051 / 271 / 7 (2.6) / 0.1447 / 314 / 9 (2.9) / 0.4663
Present / 1892 / 56 (3.0) / 1181 / 34 (2.9) / 203 / 11 (5.4) / 473 / 9 (1.9)
Stent typee
BMS only / 1547 / 41 (2.7) / 0.5149 / 949 / 25 (2.6) / 0.1948 / 107 / 5 (4.7) / 0.7769 / 466 / 11 (2.4) / 1.0000
DES only / 2107 / 48 (2.3) / 1502 / 27 (1.8) / 345 / 13 (3.8) / 208 / 5 (2.4)

MI: myocardial infarction; wk: week

The missing data are not included in the table.

a A number of patients who experienced an event for once or more; if one patient experienced the same events more than once, the patient is counted as one.

bData were compared between the groups using Fisher’s exact test for nominal variables, and Cochran-Armitage test for ordinal variables. Fisher’s exact test was also applied for ordinal variables in a two-by-two contingency table.

c Patients with multiple categories were counted more than once.

d Peripheral arterial disease included past history and comorbidity.

e BMS plus DES was excluded from this analysis.