Table 1.
Patient Characteristics at the Time of Randomization by CERT2 Risk Score Categories
| CERT2: 0 to 3 | CERT2: 4 to 6 | CERT2: 7 to 8 | CERT2: 9 to 12 | P Value | |
|---|---|---|---|---|---|
| No. | 1708 | 4943 | 2795 | 1776 | |
| Age, y | 64 (58–70) | 65 (59–71) | 65 (59–71) | 65 (58–72) | 0.0004 |
| Men, No. (%) | 1405 (82.3) | 4028 (81.5) | 2287 (81.8) | 1428 (80.4) | 0.520 |
| Geographic region, No. (%) | |||||
| Asia/Pacific | 327 (19.1) | 734 (14.8) | 321 (11.5) | 198 (11.1) | <0.0001 |
| Eastern Europe | 317 (18.6) | 1341 (27.1) | 974 (34.8) | 784 (44.1) | |
| North America | 524 (30.7) | 954 (19.3) | 384 (13.7) | 184 (10.4) | |
| South America | 49 (2.9) | 167 (3.4) | 121 (4.3) | 55 (3.1) | |
| Western Europe | 491 (28.7) | 1747 (35.3) | 995 (35.6) | 555 (31.3) | |
| Race, No. (%) | |||||
| Black | 66 (3.9) | 108 (2.2) | 50 (1.8) | 23 (1.3) | <0.0001 |
| Central/South/South East Asian | 93 (5.4) | 331 (6.7) | 202 (7.2) | 152 (8.6) | |
| East Asian/Japanese | 202 (11.8) | 317 (6.4) | 91 (3.3) | 40 (2.3) | |
| Other | 40 (2.3) | 114 (2.3) | 44 (1.6) | 31 (1.7) | |
| White | 1307 (76.5) | 4073 (82.4) | 2408 (86.2) | 1530 (86.1) | |
| Diabetes mellitus, No. (%) | 677 (39.6) | 1855 (37.5) | 1064 (38.1) | 736 (41.4) | 0.023 |
| Body mass index, kg/m2 | 28.4 (25.8–31.7) | 28.3 (25.6–31.5) | 28.5 (25.8–32.0) | 28.4 (25.3–32.0) | 0.154 |
| Systolic blood pressure, mm Hg | 130 (120–142) | 131 (121–143) | 131 (120–143) | 131 (120–144) | 0.029 |
| History of hypertension, No. (%) | 1217 (71.3) | 3513 (71.1) | 1962 (70.2) | 1270 (71.5) | 0.765 |
| Significant renal dysfunctiona | 416 (24.4) | 1416 (28.6) | 868 (31.1) | 615 (34.6) | <0.0001 |
| Prior MI, No. (%) | 1025 (60.0) | 3012 (60.9) | 1761 (63.0) | 1125 (63.3) | 0.062 |
| Prior percutaneous coronary intervention or coronary artery bypass grafting, No. (%) | 1309 (76.6) | 3606 (73.0) | 2025 (72.5) | 1230 (69.3) | <0.0001 |
| Family history of premature CHD, No. (%) | 456 (26.7) | 1256 (25.5) | 665 (23.9) | 415 (23.4) | 0.057 |
| Polyvascular disease, No. (%) | 191 (11.2) | 738 (14.9) | 478 (17.1) | 375 (21.1) | <0.0001 |
| Multivessel CAD, No. (%) | 205 (12.0) | 700 (14.2) | 440 (15.7) | 294 (16.6) | <0.0001 |
| Smoking status, No. (%) | |||||
| Never smoked | 570 (33.4) | 1540 (31.2) | 802 (28.7) | 488 (27.5) | <0.0001 |
| Current smoker | 255 (14.9) | 874 (17.7) | 590 (21.1) | 434 (24.4) | |
| Former smoker | 882 (51.7) | 2529 (51.2) | 1403 (50.2) | 854 (48.1) | |
| Missing | 8 (0.2) | 7 (0.3) | 4 (0.2) | ||
| Statin treatment, No. (%) | 1677 (98.2) | 4838 (97.9) | 2733 (97.8) | 1708 (96.2) | 0.0002 |
| High‐intensity statin treatment, No. (%) | 119 (7.0) | 326 (6.6) | 168 (6.0) | 101 (5.7) | 0.329 |
| Aspirin, No. (%) | 1622 (95) | 4591 (92.9) | 2557 (91.5) | 1579 (88.9) | <0.0001 |
| P2Y12, No. (%) | 609 (35.7) | 1662 (33.6) | 917 (32.8) | 556 (31.3) | 0.047 |
| ACEI or ARB, No. (%) | 1340 (78.5) | 3831 (77.5) | 2189 (78.3) | 1426 (80.3) | 0.111 |
| β‐Blocker, No. (%) | 1323 (77.5) | 3907 (79.0) | 2318 (82.9) | 1457 (82.0) | <0.0001 |
| Randomization to darapladib, No. (%) | 823 (48.2) | 2441 (49.4) | 1388 (49.7) | 933 (52.5) | 0.059 |
| White blood cell count, GI/L | 6.3 (5.4–7.3) | 6.5 (5.5–7.7) | 6.8 (5.7–8.0) | 7.1 (5.9–8.4) | <0.0001 |
| LDL‐C, mmol/L | 1.90 (1.53–2.33) | 2.10 (1.66–2.61) | 2.21 (1.76–2.82) | 2.42 (1.90–3.08) | <0.0001 |
| HDL‐C, mmol/L | 1.17 (1.00–1.36) | 1.19 (1.00–1.40) | 1.15 (0.98–1.37) | 1.14 (0.95–1.36) | <0.0001 |
| Triglycerides, mmol/L | 1.44 (1.06–1.95) | 1.52 (1.10–2.10) | 1.53 (1.12–2.19) | 1.57 (1.12–2.29) | <0.0001 |
| eGFR (Chronic Kidney Disease Epidemiology Collaboration), mL/min/1.73 m2 | 76.6 (64.4–88.1) | 75.1 (63.3–86.9) | 73.7 (61.0–86.2) | 73.3 (59.1–86.1) | <0.0001 |
| hs‐CRP, mgL | 0.9 (0.5–1.9) | 1.2 (0.6–2.6) | 1.8 (0.8–3.8) | 2.5 (1.1–5.8) | <0.0001 |
| hs‐TnT, ng/L | 8.4 (5.7–12.4) | 8.9 (6.1–13.5) | 10.0 (6.5–15.0) | 10.9 (6.9–17.3) | <0.0001 |
| NT‐proBNP, ng/L | 130 (64–262) | 163 (82–344) | 214 (103–464) | 283 (123–691) | <0.0001 |
| IL‐6, pg/mL | 1.7 (1.2–2.4) | 2.0 (1.4–2.9) | 2.3 (1.6–3.5) | 2.7 (1.8–4.5) | <0.0001 |
| Cystatin C, mg/L | 0.96 (0.85–1.11) | 0.99 (0.86–1.16) | 1.03 (0.89–1.21) | 1.06 (0.92–1.99) | <0.0001 |
| GDF15, pg/mL | 1138 (861–1654) | 1198 (887–1711) | 1283 (942–1852) | 1438 (1040–2170) | <0.0001 |
| Lp‐PLA2 activity, μmol/min per L | 161 (134–191) | 169 (141–200) | 178 (149–209) | 190 (156–224) | <0.0001 |
Chi‐square or Kruskal–Wallis test. CAD indicates coronary artery disease; CERT, Cardiovascular Event Risk Test; CHD, coronary heart disease; GDF15, growth differentiation factor‐15; HDL‐C, high‐density lipoprotein cholesterol; hs‐CRP, high‐sensitivity C‐reactive protein; hs‐TnT, high‐sensitivity troponin T; IL‐6, interleukin 6; LDL‐C, low‐density lipoprotein cholesterol; Lp‐PLA2, lipoprotein‐associated phospholipase A2; MI, myocardial infarction; and NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide.
a
Significant renal dysfunction defined as estimated glomerular filtration rate [eGFR] ≥30 and ≤59 mL/min per 1.73 m2 OR urine albumin creatinine ratio ≥30 mg albumin/g creatinine.