Table 1.
Baseline demographic and clinical characteristics
| Characteristic | PVD | No PVD | ||
|---|---|---|---|---|
| Inclisiran (n = 228) | Placebo (n = 242) | Inclisiran (n = 1506) | Placebo (n = 1478) | |
| Age, years, mean ± SD | 67.4 ± 8.5 | 66.9 ± 8.7 | 63.7 ± 10.1 | 63.4 ± 10.0 |
| Male, n (%) | 152 (66.7) | 168 (69.4) | 1029 (68.3) | 1025 (69.4) |
| BMI, kg/m2, mean ± SD | 30.3 ± 6.1 | 30.4 ± 5.6 | 30.4 ± 5.6 | 30.7 ± 5.8, n = 1476 |
| eGFR, mL/min/1.73 m2, median (IQR) | 73.5 (57 to 87) | 76.0 (61 to 87) | 78.0 (67 to 92) | 78.0 (66 to 91) |
| ASCVD manifestations and CV risk factors, n (%) | ||||
| ASCVD | 228 (100.0) | 242 (100.0) | 1323 (87.8) | 1311 (88.7) |
| PAD | 110 (48.2) | 115 (47.5) | 58 (3.9) | 42 (2.8) |
| CeVD | 157 (68.9) | 152 (62.8) | 110 (7.3) | 92 (6.2) |
| CHD | 221 (96.9) | 235 (97.1) | 1148 (76.2) | 1175 (79.5) |
| Myocardial infarction | 125 (54.8) | 133 (55.0) | 706 (46.9) | 729 (49.3) |
| Ischemic stroke | 117 (51.3) | 112 (46.3) | 99 (6.6) | 78 (5.3) |
| Hypertension | 206 (90.4) | 223 (92.1) | 1182 (78.5) | 1159 (78.4) |
| Heart failure | 51 (22.4) | 51 (21.1) | 151 (10.0) | 173 (11.7) |
| Diabetes mellitus | 118 (51.8) | 106 (43.8) | 503 (33.4) | 459 (31.1) |
| Current smoker | 51 (22.4) | 52 (21.5) | 241 (16.0) | 203 (13.7) |
| Lipid-lowering n (%) | ||||
| Statin use | 211 (92.5) | 222 (91.7) | 1395 (92.6) | 1362 (92.2) |
| High-intensity statin use | 167 (73.2) | 184 (76.0) | 1128 (74.9) | 1094 (74.0) |
| Ezetimibe use | 22 (9.6) | 33 (13.6) | 225 (14.9) | 229 (15.5) |
| Laboratory measurements, mean ± SD | ||||
| LDL-C, mg/dL | 102.2 ± 44.8 | 104.0 ± 38.1 | 111.2 ± 42.0 | 110.1 ± 43.5 |
| Total cholesterol, mg/dL | 178.0 ± 50.2 | 181.6 ± 44.9, n = 241 | 189.1 ± 47.7, n = 1502 | 187.3 ± 48.5, n = 1475 |
| Non-HDL-C, mg/dL | 132.3 ± 49.2 | 134.1 ± 45.4, n = 241 | 140.2 ± 46.4, n = 1502 | 139.4 ± 47.4, n = 1475 |
| HDL-C, mg/dL | 45.7 ± 13.9 | 47.4 ± 15.4, n = 241 | 48.9 ± 15.0, n = 1502 | 47.9 ± 13.8, n = 1475 |
| VLDL-C, mg/dL | 28.7 ± 15.7 | 29.5 ± 17.1 | 28.0 ± 16.0, n = 1500 | 28.3 ± 15.4, n = 1471 |
| ApoB, mg/dL | 93.4 ± 28.3, n = 227 | 95.2 ± 26.6 | 98.7 ± 27.9, n = 1502 | 98.0 ± 28.1, n = 1476 |
| Triglycerides, mg/dL | 151.1 ± 77.6 | 149.4 ± 79.8 | 145.6 ± 74.8 | 147.2 ± 77.1 |
| Lp(a), nmol/L, median (IQR) | 93.0 (24 to 200), n = 227 | 51.5 (19 to 194) | 45.0 (18 to 183), n = 1502 | 47.0 (19 to 185), n = 1475 |
| PCSK9, µg/L | 404.3 ± 111.3, n = 226 | 394.5 ± 174.6, n = 241 | 397.4 ± 152.9, n = 1501 | 390.8 ± 122.1, n = 1474 |
ApoB, apolipoprotein B; ASCVD, atherosclerotic cardiovascular disease; BMI, body mass index; CHD, coronary heart disease; CeVD, cerebrovascular disease; CV, cardiovascular; eGFR, estimated glomerular filtration rate; HDL-C, high-density lipoprotein cholesterol; IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol; Lp(a), lipoprotein(a); PAD, peripheral arterial disease; PCSK9, proprotein convertase subtilisin/kexin type 9; PVD, polyvascular disease; SD, standard deviation; VLDL-C, very-low-density lipoprotein cholesterol