Table 1. Baseline Patient Characteristics.
| Characteristic | Apabetalone (n = 1212) | Placebo (n = 1206) |
|---|---|---|
| Age, median (IQR), y | 62 (55-68) | 62 (56-68) |
| Sex, No. (%) | ||
| Women | 305 (25.2) | 313 (26.0) |
| Men | 907 (74.8) | 893 (74.0) |
| Race, No. (%) | ||
| White | 1063 (87.7) | 1056 (87.6) |
| Asian | 20 (1.7) | 19 (1.6) |
| Othera | 129 (10.6) | 131 (10.9) |
| Geographic region, No. (%) | ||
| Europe | 689 (56.8) | 686 (56.8) |
| Latin America | 315 (26.0) | 313 (26.0) |
| Israel | 188 (15.5) | 189 (15.7) |
| Taiwan | 20 (1.7) | 18 (1.5) |
| Body mass index, mean (SD) | 30.2 (4.8) [n = 1208] | 30.3 (5.0) [n = 1206] |
| Medical history before acute coronary syndrome | ||
| Hypertension, No. (%) | 1083 (89.4) | 1059 (87.8) |
| Current or former smoker, No. (%)b | 147 (12.1) | 125 (10.4) |
| Duration of diabetes, mean (SD), y | 8.4 (7.6) [n = 1211] | 8.7 (7.7) [n = 1205] |
| Previous myocardial infarction, No. (%) | 174 (14.4) | 177 (14.7) |
| Previous percutaneous coronary intervention or coronary artery bypass surgery, No. (%) | 259 (21.4) | 256 (21.2) |
| Index acute coronary syndrome, No. (%) | [n = 1208] | [n = 1195] |
| Myocardial infarction | 885 (73.3) | 893 (74.7) |
| STEMI | 466 (38.6) | 466 (39.0) |
| Non-STEMI | 413 (34.2) | 423 (35.4) |
| Unstable angina | 323 (26.7) | 302 (25.3) |
| Percutaneous coronary intervention for index acute coronary syndrome, No. (%) | 967 (79.8) | 955 (79.2) |
| Time from index acute coronary syndrome to randomization, median (IQR), d | 38 (25-63.5) | 38 (25-62) |
| Cardiovascular medications, No. (%) | ||
| Atorvastatin | 621 (51.2) | 620 (51.4) |
| Rosuvastatin | 591 (48.8) | 586 (48.6) |
| High-intensity statinc | 1089 (89.9) | 1092 (90.5) |
| Ezetimibe | 32 (2.6) | 35 (2.9) |
| PCSK-9 inhibitors | 0 | 0 |
| ACE inhibitors/angiotensin II blockers | 1119 (92.3) | 1110 (92.0) |
| β-Blockers | 1103 (91.0) | 1088 (90.2) |
| Antiplatelet agents | 1196 (98.7) | 1195 (99.1) |
| Dual antiplatelet agents | 1057 (87.2) | 1065 (88.3) |
| Diabetes medications, No. (%) | ||
| Metformin | 1009 (83.3) | 989 (82.0) |
| Insulin | 445 (36.7) | 464 (38.5) |
| Sulfonylureas | 363 (30.0) | 344 (28.5) |
| DPP4 inhibitors | 181 (14.9) | 178 (14.8) |
| SGLT2 inhibitors | 150 (12.4) | 148 (12.3) |
| GLP1 receptor agonists | 41 (3.4) | 45 (3.7) |
| Otherd | 52 (4.3) | 55 (4.6) |
| Biochemical parameters, mean (SD) | ||
| Hemoglobin A1c, median (IQR), % | 7.4 (6.4-8.7) [n = 1202] | 7.3 (6.4-8.6) [n = 1194] |
| Serum glucose, mg/dL | 152.2 (60.7) [n = 1210] | 150.7 (62.5) [n = 1205] |
| eGFR, mL/min/1.73 m2e | 104.9 (39.3) [n = 1208] | 101.7 (38.6) [n = 1205] |
| Total cholesterol, mg/dL | 134.8 (35.3) [n = 1212] | 136.8 (38.2) [n = 1206] |
| LDL cholesterol, mg/dL | 69.7 (29.8) [n = 1212] | 70.9 (32.4) [n = 1203] |
| HDL cholesterol, mg/dL | 33.3 (5.1) [n = 1212] | 33.3 (5.1) [n = 1206] |
| Triglycerides, median (IQR), mg/dL | 146.1 (110.7-198.4) [n = 1212] | 151.5 (116.0-202.8) [n = 1205] |
| Alkaline phosphatase, U/L | 83.3 (38.2) [n = 1212] | 81.9 (34.8) [n = 1206] |
| Alanine aminotransferase, U/L | 25.3 (14.3) [n = 1209] | 25.4 (14.7) [n = 1204] |
| Total bilirubin, μmol/L | 9.8 (4.2) [n = 1211] | 9.9 (4.2) [n = 1205] |
| High-sensitivity C-reactive protein, median (IQR),f mg/L | 2.9 (1.3-5.9) [n = 244] | 2.7 (1.1-6.1) [n = 239] |
Abbreviations: ACE, angiotensin-converting enzyme; DPP4, dipeptidyl peptidase 4; eGFR, estimated glomerular filtration rate; GLP1, glucagon-like peptide 1; HDL, high-density lipoprotein; IQR, interquartile range; LDL, low-density lipoprotein; PCSK9, proprotein convertase subtilisin/kexin type 9; SGLT2, sodium-glucose cotransporter 2; STEMI, ST-segment elevation myocardial infarction.
SI conversion factors: To convert cholesterol to mmol/L, multiply by 0.0259; to convert triglycerides, multiply by 0.0113; to convert from μmol/L to mg/dL, divide by 17.1. Body mass index is calculated as weight in kilograms divided by height in meters squared.
“Other” race includes fixed categories American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, and other. Ethnicity data were not collected.
Smoking status was not collected via a dedicated prospective question, and counts are based on free-form medical history data coded to “tobacco user” or “ex–tobacco user.” These counts likely underestimate actual prevalence, and current vs former smoking status cannot be reliably determined from the coded categories.
High-intensity statin is defined as 40 or 80 mg of atorvastatin or 20 or 40 mg of rosuvastatin.
Other diabetes medications include acarbose, pioglitazone, and repaglinide.
eGFR was calculated with the Cockcroft-Gault method, based on age and weight at baseline.
High-sensitivity C-reactive protein level was assessed in a subset of patients.