| Variable . | LDL-C ≥ 100 mg/dL . | LDL-C < 100 mg/dL . | |||||
|---|---|---|---|---|---|---|---|
| . | Total (N = 5304) . | CSL112 6 g (N = 2655) . | Placebo (N = 2649) . | Total (N = 10 427) . | CSL112 6 g (N = 5198) . | Placebo (N = 5229) . | P-valuea . |
| Age, years, median (IQR) | 65 (57, 71) | 65 (57, 71) | 65 (57, 71) | 67 (61, 74) | 68 (61, 74) | 67 (60, 74) | |
| Age ≥65 years, n (%) | 2835 (53.5) | 1410 (53.1) | 1425 (53.8) | 6615 (63.4) | 3324 (63.9) | 3291 (62.9) | <.0001 |
| Male sex, n (%) | 3670 (69.2) | 1846 (69.5) | 1824 (68.9) | 7975 (76.5) | 4002 (77.0) | 3973 (76.0) | <.0001 |
| Race, n (%) | <.0001 | ||||||
| White | 4487 (84.6) | 2254 (84.9) | 2233 (84.3) | 8833 (84.7) | 4425 (85.1) | 4408 (84.3) | |
| Asian | 498 (9.4) | 239 (9.0) | 259 (9.8) | 882 (8.5) | 437 (8.4) | 445 (8.5) | |
| Black/African American | 122 (2.3) | 60 (2.3) | 62 (2.3) | 178 (1.7) | 90 (1.7) | 88 (1.7) | |
| Other/multiracial | 181 (3.4) | 95 (3.6) | 86 (3.2) | 481 (4.6) | 221 (4.3) | 260 (5.0) | |
| Missing | 16 (.3) | 7 (.3) | 9 (.3) | 53 (.5) | 25 (.5) | 28 (.5) | |
| Ethnicity, n (%) | <.0001 | ||||||
| Hispanic/Latino | 822 (15.5) | 432 (16.3) | 390 (14.7) | 1891 (18.1) | 911 (17.5) | 980 (18.7) | |
| Non-Hispanic/Latino | 4416 (83.3) | 2191 (82.5) | 2225 (84.0) | 8393 (80.5) | 4216 (81.1) | 4177 (79.9) | |
| Not reported | 64 (1.2) | 31 (1.2) | 33 (1.2) | 141 (1.4) | 71 (1.4) | 70 (1.3) | |
| Missing | 2 (.0) | 1 (.0) | 1 (.0) | 2 (.0) | 0 (.0) | 2 (.0) | |
| Geographic region, n (%) | <.0001 | ||||||
| Central and Eastern Europe | 2422 (45.7) | 1199 (45.2) | 1223 (46.2) | 3209 (30.8) | 1622 (31.2) | 1587 (30.3) | |
| Western Europe | 1123 (21.2) | 571 (21.5) | 552 (20.8) | 2957 (28.4) | 1464 (28.2) | 1493 (28.6) | |
| Latin America | 763 (14.4) | 407 (15.3) | 356 (13.4) | 1727 (16.6) | 840 (16.2) | 887 (17.0) | |
| Asia Pacific | 546 (10.3) | 263 (9.9) | 283 (10.7) | 1061 (10.2) | 543 (10.4) | 518 (9.9) | |
| North America | 450 (8.5) | 215 (8.1) | 235 (8.9) | 1473 (14.1) | 729 (14.0) | 744 (14.2) | |
| BMI (kg/m2), median (IQR) | 28.1 (25.5, 31.5) | 28.1 (25.5, 31.3) | 28.1 (25.4, 31.6) | 28.3 (25.4, 31.6) | 28.3 (25.4, 31.6) | 28.3 (25.5, 31.7) | |
| Current smoking, n (%) | 1596 (30.1) | 781 (29.4) | 815 (30.8) | 2471 (23.7) | 1230 (23.7) | 1241 (23.7) | <.0001 |
| Medical history, n (%) | |||||||
| Diabetes mellitus | 3506 (66.1) | 1769 (66.6) | 1737 (65.6) | 7170 (68.8) | 3595 (69.2) | 3575 (68.4) | .0007 |
| Peripheral artery disease | 649 (12.2) | 328 (12.4) | 321 (12.1) | 1342 (12.9) | 653 (12.6) | 689 (13.2) | .2579 |
| Prior MI | 1491 (28.1) | 754 (28.4) | 737 (27.8) | 4190 (40.2) | 2066 (39.7) | 2124 (40.6) | <.0001 |
| Prior PCI | 1361 (25.7) | 692 (26.1) | 669 (25.3) | 4529 (43.4) | 2244 (43.2) | 2285 (43.7) | <.0001 |
| Heart failure | 524 (9.9) | 258 (9.7) | 266 (10.0) | 1072 (10.3) | 515 (9.9) | 557 (10.7) | .4302 |
| Ischemic stroke | 245 (4.6) | 130 (4.9) | 115 (4.3) | 584 (5.6) | 282 (5.4) | 302 (5.8) | .0092 |
| Hypertension | 4014 (75.7) | 2017 (76.0) | 1997 (75.4) | 8450 (81.0) | 4219 (81.2) | 4231 (80.9) | <.0001 |
| Hypercholesterolemia | 2735 (51.6) | 1392 (52.4) | 1343 (50.7) | 7215 (69.2) | 3593 (69.1) | 3622 (69.3) | <.0001 |
| Index MI type, n (%) | <.0001 | ||||||
| STEMI | 3093 (58.3) | 1554 (58.5) | 1539 (58.1) | 4935 (47.3) | 2468 (47.5) | 2467 (47.2) | |
| NSTEMI | 2211 (41.7) | 1101 (41.5) | 1110 (41.9) | 5492 (52.7) | 2730 (52.5) | 2762 (52.8) | |
| Coronary angiography for the index MI, n (%) | 5197 (98.0) | 2600 (97.9) | 2597 (98.0) | 10 112 (97.0) | 5045 (97.1) | 5067 (96.9) | .0002 |
| PCI for the index MI, n (%) | 4826 (91.0) | 2416 (91.0) | 2410 (91.0) | 9027 (86.6) | 4519 (86.9) | 4508 (86.2) | <.0001 |
| Medications at randomization, n (%) | |||||||
| Aspirin | 5056 (95.3) | 2541 (95.7) | 2515 (94.9) | 9830 (94.3) | 4909 (94.4) | 4921 (94.1) | .0058 |
| P2Y12 inhibitor | 5061 (95.4) | 2540 (95.7) | 2521 (95.2) | 9848 (94.4) | 4921 (94.7) | 4927 (94.2) | .0096 |
| High-intensity statinb | 4423 (83.4) | 2228 (83.9) | 2195 (82.9) | 8402 (80.6) | 4184 (80.5) | 4218 (80.7) | <.0001 |
| Non-statin lipid-lowering drugs | 476 (9.0) | 239 (9.0) | 237 (8.9) | 1250 (12.0) | 623 (12.0) | 627 (12.0) | <.0001 |
| Medications prior to the index MI, n (%) | |||||||
| Statin | 1675 (31.6) | 848 (31.9) | 827 (31.2) | 6074 (58.3) | 3019 (58.1) | 3055 (58.4) | <.0001 |
| High-intensity statinb | 604 (11.4) | 309 (11.6) | 295 (11.1) | 2456 (23.6) | 1218 (23.4) | 1238 (23.7) | <.0001 |
| Non-statin lipid-lowering drugs | 188 (3.5) | 103 (3.9) | 85 (3.2) | 834 (8.0) | 404 (7.8) | 430 (8.2) | <.0001 |
| Lipid panel as baseline, median (IQR) | |||||||
| Total cholesterol (mg/dL) | 201.9 (184.8, 225.4) | 202.2 (185.2, 225.4) | 201.5 (184.1, 225.1) | 141.1 (122.2, 157.8) | 141.1 (122.6, 157.8) | 140.8 (122.2, 157.8) | <.0001 |
| LDL cholesterol (mg/dL) | 123.0 (110.6, 143.5) | 123.0 (111.0, 143.9) | 123.0 (110.2, 142.7) | 69.2 (53.4, 83.1) | 68.8 (53.0, 82.8) | 69.2 (54.1, 83.9) | <.0001 |
| HDL cholesterol (mg/dL) | 41.0 (34.8, 48.0) | 40.6 (34.8, 47.6) | 41.0 (34.8, 48.3) | 39.1 (32.9, 46.4) | 39.1 (32.9, 46.4) | 39.1 (33.3, 46.0) | <.0001 |
| Triglycerides (mg/dL) | 165.6 (128.4, 215.2) | 166.5 (130.2, 216.1) | 164.7 (126.7, 215.2) | 142.6 (109.8, 191.3) | 144.4 (109.8, 194.0) | 142.6 (109.8, 188.7) | <.0001 |
| Lipid panel at end of active treatment period, median (IQR) | |||||||
| Total cholesterol (mg/dL) | 145.0 (123.7, 172.5) | 151.2 (129.9, 178.7) | 140.0 (119.9, 165.5) | 124.9 (107.1, 146.6) | 129.9 (111.4, 151.6) | 120.7 (104.0, 141.1) | <.0001 |
| LDL cholesterol (mg/dL) | 70.4 (54.1, 90.9) | 73.1 (56.5, 93.2) | 68.1 (52.6, 88.2) | 52.2 (39.4, 66.9) | 53.8 (40.6, 68.1) | 51.0 (38.3, 66.1) | <.0001 |
| HDL cholesterol (mg/dL) | 42.2 (36.0, 50.3) | 44.5 (37.5, 53.8) | 39.8 (34.8, 47.2) | 41.0 (34.8, 49.9) | 43.3 (36.0, 53.4) | 39.8 (34.0, 47.2) | <.0001 |
| Triglycerides (mg/dL) | 139.9 (106.3, 187.8) | 144.4 (109.8, 192.2) | 136.4 (102.7, 183.3) | 132.9 (99.2, 182.5) | 136.4 (102.7, 188.7) | 128.4 (97.4, 175.4) | <.0001 |
| Renal function, n (%) | <.0001 | ||||||
| Normal (eGFR ≥90 mL/min/1.73 m2) | 1468 (27.7) | 748 (28.2) | 720 (27.2) | 2464 (23.6) | 1214 (23.4) | 1250 (23.9) | |
| Mild impairment (eGFR ≥60-<90 mL/min/1.73 m2) | 2670 (50.3) | 1358 (51.1) | 1312 (49.5) | 5329 (51.1) | 2684 (51.6) | 2645 (50.6) | |
| Moderate impairment (eGFR ≥30-<60 mL/min/1.73 m2) | 1130 (21.3) | 531 (20.0) | 599 (22.6) | 2560 (24.6) | 1256 (24.2) | 1304 (24.9) | |
| Severe impairment (eGFR <30 mL/min/1.73 m2) | 29 (.5) | 15 (.6) | 14 (.5) | 62 (.6) | 39 (.8) | 23 (.4) | |
| Missing | 7 (.1) | 3 (.1) | 4 (.2) | 12 (.1) | 5 (.1) | 7 (.1) | |
| Variable . | LDL-C ≥ 100 mg/dL . | LDL-C < 100 mg/dL . | |||||
|---|---|---|---|---|---|---|---|
| . | Total (N = 5304) . | CSL112 6 g (N = 2655) . | Placebo (N = 2649) . | Total (N = 10 427) . | CSL112 6 g (N = 5198) . | Placebo (N = 5229) . | P-valuea . |
| Age, years, median (IQR) | 65 (57, 71) | 65 (57, 71) | 65 (57, 71) | 67 (61, 74) | 68 (61, 74) | 67 (60, 74) | |
| Age ≥65 years, n (%) | 2835 (53.5) | 1410 (53.1) | 1425 (53.8) | 6615 (63.4) | 3324 (63.9) | 3291 (62.9) | <.0001 |
| Male sex, n (%) | 3670 (69.2) | 1846 (69.5) | 1824 (68.9) | 7975 (76.5) | 4002 (77.0) | 3973 (76.0) | <.0001 |
| Race, n (%) | <.0001 | ||||||
| White | 4487 (84.6) | 2254 (84.9) | 2233 (84.3) | 8833 (84.7) | 4425 (85.1) | 4408 (84.3) | |
| Asian | 498 (9.4) | 239 (9.0) | 259 (9.8) | 882 (8.5) | 437 (8.4) | 445 (8.5) | |
| Black/African American | 122 (2.3) | 60 (2.3) | 62 (2.3) | 178 (1.7) | 90 (1.7) | 88 (1.7) | |
| Other/multiracial | 181 (3.4) | 95 (3.6) | 86 (3.2) | 481 (4.6) | 221 (4.3) | 260 (5.0) | |
| Missing | 16 (.3) | 7 (.3) | 9 (.3) | 53 (.5) | 25 (.5) | 28 (.5) | |
| Ethnicity, n (%) | <.0001 | ||||||
| Hispanic/Latino | 822 (15.5) | 432 (16.3) | 390 (14.7) | 1891 (18.1) | 911 (17.5) | 980 (18.7) | |
| Non-Hispanic/Latino | 4416 (83.3) | 2191 (82.5) | 2225 (84.0) | 8393 (80.5) | 4216 (81.1) | 4177 (79.9) | |
| Not reported | 64 (1.2) | 31 (1.2) | 33 (1.2) | 141 (1.4) | 71 (1.4) | 70 (1.3) | |
| Missing | 2 (.0) | 1 (.0) | 1 (.0) | 2 (.0) | 0 (.0) | 2 (.0) | |
| Geographic region, n (%) | <.0001 | ||||||
| Central and Eastern Europe | 2422 (45.7) | 1199 (45.2) | 1223 (46.2) | 3209 (30.8) | 1622 (31.2) | 1587 (30.3) | |
| Western Europe | 1123 (21.2) | 571 (21.5) | 552 (20.8) | 2957 (28.4) | 1464 (28.2) | 1493 (28.6) | |
| Latin America | 763 (14.4) | 407 (15.3) | 356 (13.4) | 1727 (16.6) | 840 (16.2) | 887 (17.0) | |
| Asia Pacific | 546 (10.3) | 263 (9.9) | 283 (10.7) | 1061 (10.2) | 543 (10.4) | 518 (9.9) | |
| North America | 450 (8.5) | 215 (8.1) | 235 (8.9) | 1473 (14.1) | 729 (14.0) | 744 (14.2) | |
| BMI (kg/m2), median (IQR) | 28.1 (25.5, 31.5) | 28.1 (25.5, 31.3) | 28.1 (25.4, 31.6) | 28.3 (25.4, 31.6) | 28.3 (25.4, 31.6) | 28.3 (25.5, 31.7) | |
| Current smoking, n (%) | 1596 (30.1) | 781 (29.4) | 815 (30.8) | 2471 (23.7) | 1230 (23.7) | 1241 (23.7) | <.0001 |
| Medical history, n (%) | |||||||
| Diabetes mellitus | 3506 (66.1) | 1769 (66.6) | 1737 (65.6) | 7170 (68.8) | 3595 (69.2) | 3575 (68.4) | .0007 |
| Peripheral artery disease | 649 (12.2) | 328 (12.4) | 321 (12.1) | 1342 (12.9) | 653 (12.6) | 689 (13.2) | .2579 |
| Prior MI | 1491 (28.1) | 754 (28.4) | 737 (27.8) | 4190 (40.2) | 2066 (39.7) | 2124 (40.6) | <.0001 |
| Prior PCI | 1361 (25.7) | 692 (26.1) | 669 (25.3) | 4529 (43.4) | 2244 (43.2) | 2285 (43.7) | <.0001 |
| Heart failure | 524 (9.9) | 258 (9.7) | 266 (10.0) | 1072 (10.3) | 515 (9.9) | 557 (10.7) | .4302 |
| Ischemic stroke | 245 (4.6) | 130 (4.9) | 115 (4.3) | 584 (5.6) | 282 (5.4) | 302 (5.8) | .0092 |
| Hypertension | 4014 (75.7) | 2017 (76.0) | 1997 (75.4) | 8450 (81.0) | 4219 (81.2) | 4231 (80.9) | <.0001 |
| Hypercholesterolemia | 2735 (51.6) | 1392 (52.4) | 1343 (50.7) | 7215 (69.2) | 3593 (69.1) | 3622 (69.3) | <.0001 |
| Index MI type, n (%) | <.0001 | ||||||
| STEMI | 3093 (58.3) | 1554 (58.5) | 1539 (58.1) | 4935 (47.3) | 2468 (47.5) | 2467 (47.2) | |
| NSTEMI | 2211 (41.7) | 1101 (41.5) | 1110 (41.9) | 5492 (52.7) | 2730 (52.5) | 2762 (52.8) | |
| Coronary angiography for the index MI, n (%) | 5197 (98.0) | 2600 (97.9) | 2597 (98.0) | 10 112 (97.0) | 5045 (97.1) | 5067 (96.9) | .0002 |
| PCI for the index MI, n (%) | 4826 (91.0) | 2416 (91.0) | 2410 (91.0) | 9027 (86.6) | 4519 (86.9) | 4508 (86.2) | <.0001 |
| Medications at randomization, n (%) | |||||||
| Aspirin | 5056 (95.3) | 2541 (95.7) | 2515 (94.9) | 9830 (94.3) | 4909 (94.4) | 4921 (94.1) | .0058 |
| P2Y12 inhibitor | 5061 (95.4) | 2540 (95.7) | 2521 (95.2) | 9848 (94.4) | 4921 (94.7) | 4927 (94.2) | .0096 |
| High-intensity statinb | 4423 (83.4) | 2228 (83.9) | 2195 (82.9) | 8402 (80.6) | 4184 (80.5) | 4218 (80.7) | <.0001 |
| Non-statin lipid-lowering drugs | 476 (9.0) | 239 (9.0) | 237 (8.9) | 1250 (12.0) | 623 (12.0) | 627 (12.0) | <.0001 |
| Medications prior to the index MI, n (%) | |||||||
| Statin | 1675 (31.6) | 848 (31.9) | 827 (31.2) | 6074 (58.3) | 3019 (58.1) | 3055 (58.4) | <.0001 |
| High-intensity statinb | 604 (11.4) | 309 (11.6) | 295 (11.1) | 2456 (23.6) | 1218 (23.4) | 1238 (23.7) | <.0001 |
| Non-statin lipid-lowering drugs | 188 (3.5) | 103 (3.9) | 85 (3.2) | 834 (8.0) | 404 (7.8) | 430 (8.2) | <.0001 |
| Lipid panel as baseline, median (IQR) | |||||||
| Total cholesterol (mg/dL) | 201.9 (184.8, 225.4) | 202.2 (185.2, 225.4) | 201.5 (184.1, 225.1) | 141.1 (122.2, 157.8) | 141.1 (122.6, 157.8) | 140.8 (122.2, 157.8) | <.0001 |
| LDL cholesterol (mg/dL) | 123.0 (110.6, 143.5) | 123.0 (111.0, 143.9) | 123.0 (110.2, 142.7) | 69.2 (53.4, 83.1) | 68.8 (53.0, 82.8) | 69.2 (54.1, 83.9) | <.0001 |
| HDL cholesterol (mg/dL) | 41.0 (34.8, 48.0) | 40.6 (34.8, 47.6) | 41.0 (34.8, 48.3) | 39.1 (32.9, 46.4) | 39.1 (32.9, 46.4) | 39.1 (33.3, 46.0) | <.0001 |
| Triglycerides (mg/dL) | 165.6 (128.4, 215.2) | 166.5 (130.2, 216.1) | 164.7 (126.7, 215.2) | 142.6 (109.8, 191.3) | 144.4 (109.8, 194.0) | 142.6 (109.8, 188.7) | <.0001 |
| Lipid panel at end of active treatment period, median (IQR) | |||||||
| Total cholesterol (mg/dL) | 145.0 (123.7, 172.5) | 151.2 (129.9, 178.7) | 140.0 (119.9, 165.5) | 124.9 (107.1, 146.6) | 129.9 (111.4, 151.6) | 120.7 (104.0, 141.1) | <.0001 |
| LDL cholesterol (mg/dL) | 70.4 (54.1, 90.9) | 73.1 (56.5, 93.2) | 68.1 (52.6, 88.2) | 52.2 (39.4, 66.9) | 53.8 (40.6, 68.1) | 51.0 (38.3, 66.1) | <.0001 |
| HDL cholesterol (mg/dL) | 42.2 (36.0, 50.3) | 44.5 (37.5, 53.8) | 39.8 (34.8, 47.2) | 41.0 (34.8, 49.9) | 43.3 (36.0, 53.4) | 39.8 (34.0, 47.2) | <.0001 |
| Triglycerides (mg/dL) | 139.9 (106.3, 187.8) | 144.4 (109.8, 192.2) | 136.4 (102.7, 183.3) | 132.9 (99.2, 182.5) | 136.4 (102.7, 188.7) | 128.4 (97.4, 175.4) | <.0001 |
| Renal function, n (%) | <.0001 | ||||||
| Normal (eGFR ≥90 mL/min/1.73 m2) | 1468 (27.7) | 748 (28.2) | 720 (27.2) | 2464 (23.6) | 1214 (23.4) | 1250 (23.9) | |
| Mild impairment (eGFR ≥60-<90 mL/min/1.73 m2) | 2670 (50.3) | 1358 (51.1) | 1312 (49.5) | 5329 (51.1) | 2684 (51.6) | 2645 (50.6) | |
| Moderate impairment (eGFR ≥30-<60 mL/min/1.73 m2) | 1130 (21.3) | 531 (20.0) | 599 (22.6) | 2560 (24.6) | 1256 (24.2) | 1304 (24.9) | |
| Severe impairment (eGFR <30 mL/min/1.73 m2) | 29 (.5) | 15 (.6) | 14 (.5) | 62 (.6) | 39 (.8) | 23 (.4) | |
| Missing | 7 (.1) | 3 (.1) | 4 (.2) | 12 (.1) | 5 (.1) | 7 (.1) | |
Note: To convert the values for HDL cholesterol and LDL cholesterol to millimoles per liter, multiply by .02586. To convert the values for triglycerides to millimoles per liter, multiply by .01129.
Abbreviations: BMI, body mass index; eGFR, estimated glomerular filtration rate; IQR, interquartile range; HDL, high-density lipoprotein; LDL-C, low-density lipoprotein cholesterol; MI, myocardial infarction; NSTEMI, non-ST-segment elevation myocardial infarction; PCI, percutaneous coronary intervention; SD, standard deviation; STEMI, ST-segment elevation myocardial infarction.
aThe P-value is the Wilcoxon rank sum nonparametric for continuous χ2 tests for categorical in the comparison between total columns for LDL-C < 100 mg/dL compared with LDL-C ≥ 100 mg/dL.
bHigh-intensity statin therapy was derived based on reported use of atorvastatin ≥40 mg daily or rosuvastatin ≥20 mg daily.
| Variable . | LDL-C ≥ 100 mg/dL . | LDL-C < 100 mg/dL . | |||||
|---|---|---|---|---|---|---|---|
| . | Total (N = 5304) . | CSL112 6 g (N = 2655) . | Placebo (N = 2649) . | Total (N = 10 427) . | CSL112 6 g (N = 5198) . | Placebo (N = 5229) . | P-valuea . |
| Age, years, median (IQR) | 65 (57, 71) | 65 (57, 71) | 65 (57, 71) | 67 (61, 74) | 68 (61, 74) | 67 (60, 74) | |
| Age ≥65 years, n (%) | 2835 (53.5) | 1410 (53.1) | 1425 (53.8) | 6615 (63.4) | 3324 (63.9) | 3291 (62.9) | <.0001 |
| Male sex, n (%) | 3670 (69.2) | 1846 (69.5) | 1824 (68.9) | 7975 (76.5) | 4002 (77.0) | 3973 (76.0) | <.0001 |
| Race, n (%) | <.0001 | ||||||
| White | 4487 (84.6) | 2254 (84.9) | 2233 (84.3) | 8833 (84.7) | 4425 (85.1) | 4408 (84.3) | |
| Asian | 498 (9.4) | 239 (9.0) | 259 (9.8) | 882 (8.5) | 437 (8.4) | 445 (8.5) | |
| Black/African American | 122 (2.3) | 60 (2.3) | 62 (2.3) | 178 (1.7) | 90 (1.7) | 88 (1.7) | |
| Other/multiracial | 181 (3.4) | 95 (3.6) | 86 (3.2) | 481 (4.6) | 221 (4.3) | 260 (5.0) | |
| Missing | 16 (.3) | 7 (.3) | 9 (.3) | 53 (.5) | 25 (.5) | 28 (.5) | |
| Ethnicity, n (%) | <.0001 | ||||||
| Hispanic/Latino | 822 (15.5) | 432 (16.3) | 390 (14.7) | 1891 (18.1) | 911 (17.5) | 980 (18.7) | |
| Non-Hispanic/Latino | 4416 (83.3) | 2191 (82.5) | 2225 (84.0) | 8393 (80.5) | 4216 (81.1) | 4177 (79.9) | |
| Not reported | 64 (1.2) | 31 (1.2) | 33 (1.2) | 141 (1.4) | 71 (1.4) | 70 (1.3) | |
| Missing | 2 (.0) | 1 (.0) | 1 (.0) | 2 (.0) | 0 (.0) | 2 (.0) | |
| Geographic region, n (%) | <.0001 | ||||||
| Central and Eastern Europe | 2422 (45.7) | 1199 (45.2) | 1223 (46.2) | 3209 (30.8) | 1622 (31.2) | 1587 (30.3) | |
| Western Europe | 1123 (21.2) | 571 (21.5) | 552 (20.8) | 2957 (28.4) | 1464 (28.2) | 1493 (28.6) | |
| Latin America | 763 (14.4) | 407 (15.3) | 356 (13.4) | 1727 (16.6) | 840 (16.2) | 887 (17.0) | |
| Asia Pacific | 546 (10.3) | 263 (9.9) | 283 (10.7) | 1061 (10.2) | 543 (10.4) | 518 (9.9) | |
| North America | 450 (8.5) | 215 (8.1) | 235 (8.9) | 1473 (14.1) | 729 (14.0) | 744 (14.2) | |
| BMI (kg/m2), median (IQR) | 28.1 (25.5, 31.5) | 28.1 (25.5, 31.3) | 28.1 (25.4, 31.6) | 28.3 (25.4, 31.6) | 28.3 (25.4, 31.6) | 28.3 (25.5, 31.7) | |
| Current smoking, n (%) | 1596 (30.1) | 781 (29.4) | 815 (30.8) | 2471 (23.7) | 1230 (23.7) | 1241 (23.7) | <.0001 |
| Medical history, n (%) | |||||||
| Diabetes mellitus | 3506 (66.1) | 1769 (66.6) | 1737 (65.6) | 7170 (68.8) | 3595 (69.2) | 3575 (68.4) | .0007 |
| Peripheral artery disease | 649 (12.2) | 328 (12.4) | 321 (12.1) | 1342 (12.9) | 653 (12.6) | 689 (13.2) | .2579 |
| Prior MI | 1491 (28.1) | 754 (28.4) | 737 (27.8) | 4190 (40.2) | 2066 (39.7) | 2124 (40.6) | <.0001 |
| Prior PCI | 1361 (25.7) | 692 (26.1) | 669 (25.3) | 4529 (43.4) | 2244 (43.2) | 2285 (43.7) | <.0001 |
| Heart failure | 524 (9.9) | 258 (9.7) | 266 (10.0) | 1072 (10.3) | 515 (9.9) | 557 (10.7) | .4302 |
| Ischemic stroke | 245 (4.6) | 130 (4.9) | 115 (4.3) | 584 (5.6) | 282 (5.4) | 302 (5.8) | .0092 |
| Hypertension | 4014 (75.7) | 2017 (76.0) | 1997 (75.4) | 8450 (81.0) | 4219 (81.2) | 4231 (80.9) | <.0001 |
| Hypercholesterolemia | 2735 (51.6) | 1392 (52.4) | 1343 (50.7) | 7215 (69.2) | 3593 (69.1) | 3622 (69.3) | <.0001 |
| Index MI type, n (%) | <.0001 | ||||||
| STEMI | 3093 (58.3) | 1554 (58.5) | 1539 (58.1) | 4935 (47.3) | 2468 (47.5) | 2467 (47.2) | |
| NSTEMI | 2211 (41.7) | 1101 (41.5) | 1110 (41.9) | 5492 (52.7) | 2730 (52.5) | 2762 (52.8) | |
| Coronary angiography for the index MI, n (%) | 5197 (98.0) | 2600 (97.9) | 2597 (98.0) | 10 112 (97.0) | 5045 (97.1) | 5067 (96.9) | .0002 |
| PCI for the index MI, n (%) | 4826 (91.0) | 2416 (91.0) | 2410 (91.0) | 9027 (86.6) | 4519 (86.9) | 4508 (86.2) | <.0001 |
| Medications at randomization, n (%) | |||||||
| Aspirin | 5056 (95.3) | 2541 (95.7) | 2515 (94.9) | 9830 (94.3) | 4909 (94.4) | 4921 (94.1) | .0058 |
| P2Y12 inhibitor | 5061 (95.4) | 2540 (95.7) | 2521 (95.2) | 9848 (94.4) | 4921 (94.7) | 4927 (94.2) | .0096 |
| High-intensity statinb | 4423 (83.4) | 2228 (83.9) | 2195 (82.9) | 8402 (80.6) | 4184 (80.5) | 4218 (80.7) | <.0001 |
| Non-statin lipid-lowering drugs | 476 (9.0) | 239 (9.0) | 237 (8.9) | 1250 (12.0) | 623 (12.0) | 627 (12.0) | <.0001 |
| Medications prior to the index MI, n (%) | |||||||
| Statin | 1675 (31.6) | 848 (31.9) | 827 (31.2) | 6074 (58.3) | 3019 (58.1) | 3055 (58.4) | <.0001 |
| High-intensity statinb | 604 (11.4) | 309 (11.6) | 295 (11.1) | 2456 (23.6) | 1218 (23.4) | 1238 (23.7) | <.0001 |
| Non-statin lipid-lowering drugs | 188 (3.5) | 103 (3.9) | 85 (3.2) | 834 (8.0) | 404 (7.8) | 430 (8.2) | <.0001 |
| Lipid panel as baseline, median (IQR) | |||||||
| Total cholesterol (mg/dL) | 201.9 (184.8, 225.4) | 202.2 (185.2, 225.4) | 201.5 (184.1, 225.1) | 141.1 (122.2, 157.8) | 141.1 (122.6, 157.8) | 140.8 (122.2, 157.8) | <.0001 |
| LDL cholesterol (mg/dL) | 123.0 (110.6, 143.5) | 123.0 (111.0, 143.9) | 123.0 (110.2, 142.7) | 69.2 (53.4, 83.1) | 68.8 (53.0, 82.8) | 69.2 (54.1, 83.9) | <.0001 |
| HDL cholesterol (mg/dL) | 41.0 (34.8, 48.0) | 40.6 (34.8, 47.6) | 41.0 (34.8, 48.3) | 39.1 (32.9, 46.4) | 39.1 (32.9, 46.4) | 39.1 (33.3, 46.0) | <.0001 |
| Triglycerides (mg/dL) | 165.6 (128.4, 215.2) | 166.5 (130.2, 216.1) | 164.7 (126.7, 215.2) | 142.6 (109.8, 191.3) | 144.4 (109.8, 194.0) | 142.6 (109.8, 188.7) | <.0001 |
| Lipid panel at end of active treatment period, median (IQR) | |||||||
| Total cholesterol (mg/dL) | 145.0 (123.7, 172.5) | 151.2 (129.9, 178.7) | 140.0 (119.9, 165.5) | 124.9 (107.1, 146.6) | 129.9 (111.4, 151.6) | 120.7 (104.0, 141.1) | <.0001 |
| LDL cholesterol (mg/dL) | 70.4 (54.1, 90.9) | 73.1 (56.5, 93.2) | 68.1 (52.6, 88.2) | 52.2 (39.4, 66.9) | 53.8 (40.6, 68.1) | 51.0 (38.3, 66.1) | <.0001 |
| HDL cholesterol (mg/dL) | 42.2 (36.0, 50.3) | 44.5 (37.5, 53.8) | 39.8 (34.8, 47.2) | 41.0 (34.8, 49.9) | 43.3 (36.0, 53.4) | 39.8 (34.0, 47.2) | <.0001 |
| Triglycerides (mg/dL) | 139.9 (106.3, 187.8) | 144.4 (109.8, 192.2) | 136.4 (102.7, 183.3) | 132.9 (99.2, 182.5) | 136.4 (102.7, 188.7) | 128.4 (97.4, 175.4) | <.0001 |
| Renal function, n (%) | <.0001 | ||||||
| Normal (eGFR ≥90 mL/min/1.73 m2) | 1468 (27.7) | 748 (28.2) | 720 (27.2) | 2464 (23.6) | 1214 (23.4) | 1250 (23.9) | |
| Mild impairment (eGFR ≥60-<90 mL/min/1.73 m2) | 2670 (50.3) | 1358 (51.1) | 1312 (49.5) | 5329 (51.1) | 2684 (51.6) | 2645 (50.6) | |
| Moderate impairment (eGFR ≥30-<60 mL/min/1.73 m2) | 1130 (21.3) | 531 (20.0) | 599 (22.6) | 2560 (24.6) | 1256 (24.2) | 1304 (24.9) | |
| Severe impairment (eGFR <30 mL/min/1.73 m2) | 29 (.5) | 15 (.6) | 14 (.5) | 62 (.6) | 39 (.8) | 23 (.4) | |
| Missing | 7 (.1) | 3 (.1) | 4 (.2) | 12 (.1) | 5 (.1) | 7 (.1) | |
| Variable . | LDL-C ≥ 100 mg/dL . | LDL-C < 100 mg/dL . | |||||
|---|---|---|---|---|---|---|---|
| . | Total (N = 5304) . | CSL112 6 g (N = 2655) . | Placebo (N = 2649) . | Total (N = 10 427) . | CSL112 6 g (N = 5198) . | Placebo (N = 5229) . | P-valuea . |
| Age, years, median (IQR) | 65 (57, 71) | 65 (57, 71) | 65 (57, 71) | 67 (61, 74) | 68 (61, 74) | 67 (60, 74) | |
| Age ≥65 years, n (%) | 2835 (53.5) | 1410 (53.1) | 1425 (53.8) | 6615 (63.4) | 3324 (63.9) | 3291 (62.9) | <.0001 |
| Male sex, n (%) | 3670 (69.2) | 1846 (69.5) | 1824 (68.9) | 7975 (76.5) | 4002 (77.0) | 3973 (76.0) | <.0001 |
| Race, n (%) | <.0001 | ||||||
| White | 4487 (84.6) | 2254 (84.9) | 2233 (84.3) | 8833 (84.7) | 4425 (85.1) | 4408 (84.3) | |
| Asian | 498 (9.4) | 239 (9.0) | 259 (9.8) | 882 (8.5) | 437 (8.4) | 445 (8.5) | |
| Black/African American | 122 (2.3) | 60 (2.3) | 62 (2.3) | 178 (1.7) | 90 (1.7) | 88 (1.7) | |
| Other/multiracial | 181 (3.4) | 95 (3.6) | 86 (3.2) | 481 (4.6) | 221 (4.3) | 260 (5.0) | |
| Missing | 16 (.3) | 7 (.3) | 9 (.3) | 53 (.5) | 25 (.5) | 28 (.5) | |
| Ethnicity, n (%) | <.0001 | ||||||
| Hispanic/Latino | 822 (15.5) | 432 (16.3) | 390 (14.7) | 1891 (18.1) | 911 (17.5) | 980 (18.7) | |
| Non-Hispanic/Latino | 4416 (83.3) | 2191 (82.5) | 2225 (84.0) | 8393 (80.5) | 4216 (81.1) | 4177 (79.9) | |
| Not reported | 64 (1.2) | 31 (1.2) | 33 (1.2) | 141 (1.4) | 71 (1.4) | 70 (1.3) | |
| Missing | 2 (.0) | 1 (.0) | 1 (.0) | 2 (.0) | 0 (.0) | 2 (.0) | |
| Geographic region, n (%) | <.0001 | ||||||
| Central and Eastern Europe | 2422 (45.7) | 1199 (45.2) | 1223 (46.2) | 3209 (30.8) | 1622 (31.2) | 1587 (30.3) | |
| Western Europe | 1123 (21.2) | 571 (21.5) | 552 (20.8) | 2957 (28.4) | 1464 (28.2) | 1493 (28.6) | |
| Latin America | 763 (14.4) | 407 (15.3) | 356 (13.4) | 1727 (16.6) | 840 (16.2) | 887 (17.0) | |
| Asia Pacific | 546 (10.3) | 263 (9.9) | 283 (10.7) | 1061 (10.2) | 543 (10.4) | 518 (9.9) | |
| North America | 450 (8.5) | 215 (8.1) | 235 (8.9) | 1473 (14.1) | 729 (14.0) | 744 (14.2) | |
| BMI (kg/m2), median (IQR) | 28.1 (25.5, 31.5) | 28.1 (25.5, 31.3) | 28.1 (25.4, 31.6) | 28.3 (25.4, 31.6) | 28.3 (25.4, 31.6) | 28.3 (25.5, 31.7) | |
| Current smoking, n (%) | 1596 (30.1) | 781 (29.4) | 815 (30.8) | 2471 (23.7) | 1230 (23.7) | 1241 (23.7) | <.0001 |
| Medical history, n (%) | |||||||
| Diabetes mellitus | 3506 (66.1) | 1769 (66.6) | 1737 (65.6) | 7170 (68.8) | 3595 (69.2) | 3575 (68.4) | .0007 |
| Peripheral artery disease | 649 (12.2) | 328 (12.4) | 321 (12.1) | 1342 (12.9) | 653 (12.6) | 689 (13.2) | .2579 |
| Prior MI | 1491 (28.1) | 754 (28.4) | 737 (27.8) | 4190 (40.2) | 2066 (39.7) | 2124 (40.6) | <.0001 |
| Prior PCI | 1361 (25.7) | 692 (26.1) | 669 (25.3) | 4529 (43.4) | 2244 (43.2) | 2285 (43.7) | <.0001 |
| Heart failure | 524 (9.9) | 258 (9.7) | 266 (10.0) | 1072 (10.3) | 515 (9.9) | 557 (10.7) | .4302 |
| Ischemic stroke | 245 (4.6) | 130 (4.9) | 115 (4.3) | 584 (5.6) | 282 (5.4) | 302 (5.8) | .0092 |
| Hypertension | 4014 (75.7) | 2017 (76.0) | 1997 (75.4) | 8450 (81.0) | 4219 (81.2) | 4231 (80.9) | <.0001 |
| Hypercholesterolemia | 2735 (51.6) | 1392 (52.4) | 1343 (50.7) | 7215 (69.2) | 3593 (69.1) | 3622 (69.3) | <.0001 |
| Index MI type, n (%) | <.0001 | ||||||
| STEMI | 3093 (58.3) | 1554 (58.5) | 1539 (58.1) | 4935 (47.3) | 2468 (47.5) | 2467 (47.2) | |
| NSTEMI | 2211 (41.7) | 1101 (41.5) | 1110 (41.9) | 5492 (52.7) | 2730 (52.5) | 2762 (52.8) | |
| Coronary angiography for the index MI, n (%) | 5197 (98.0) | 2600 (97.9) | 2597 (98.0) | 10 112 (97.0) | 5045 (97.1) | 5067 (96.9) | .0002 |
| PCI for the index MI, n (%) | 4826 (91.0) | 2416 (91.0) | 2410 (91.0) | 9027 (86.6) | 4519 (86.9) | 4508 (86.2) | <.0001 |
| Medications at randomization, n (%) | |||||||
| Aspirin | 5056 (95.3) | 2541 (95.7) | 2515 (94.9) | 9830 (94.3) | 4909 (94.4) | 4921 (94.1) | .0058 |
| P2Y12 inhibitor | 5061 (95.4) | 2540 (95.7) | 2521 (95.2) | 9848 (94.4) | 4921 (94.7) | 4927 (94.2) | .0096 |
| High-intensity statinb | 4423 (83.4) | 2228 (83.9) | 2195 (82.9) | 8402 (80.6) | 4184 (80.5) | 4218 (80.7) | <.0001 |
| Non-statin lipid-lowering drugs | 476 (9.0) | 239 (9.0) | 237 (8.9) | 1250 (12.0) | 623 (12.0) | 627 (12.0) | <.0001 |
| Medications prior to the index MI, n (%) | |||||||
| Statin | 1675 (31.6) | 848 (31.9) | 827 (31.2) | 6074 (58.3) | 3019 (58.1) | 3055 (58.4) | <.0001 |
| High-intensity statinb | 604 (11.4) | 309 (11.6) | 295 (11.1) | 2456 (23.6) | 1218 (23.4) | 1238 (23.7) | <.0001 |
| Non-statin lipid-lowering drugs | 188 (3.5) | 103 (3.9) | 85 (3.2) | 834 (8.0) | 404 (7.8) | 430 (8.2) | <.0001 |
| Lipid panel as baseline, median (IQR) | |||||||
| Total cholesterol (mg/dL) | 201.9 (184.8, 225.4) | 202.2 (185.2, 225.4) | 201.5 (184.1, 225.1) | 141.1 (122.2, 157.8) | 141.1 (122.6, 157.8) | 140.8 (122.2, 157.8) | <.0001 |
| LDL cholesterol (mg/dL) | 123.0 (110.6, 143.5) | 123.0 (111.0, 143.9) | 123.0 (110.2, 142.7) | 69.2 (53.4, 83.1) | 68.8 (53.0, 82.8) | 69.2 (54.1, 83.9) | <.0001 |
| HDL cholesterol (mg/dL) | 41.0 (34.8, 48.0) | 40.6 (34.8, 47.6) | 41.0 (34.8, 48.3) | 39.1 (32.9, 46.4) | 39.1 (32.9, 46.4) | 39.1 (33.3, 46.0) | <.0001 |
| Triglycerides (mg/dL) | 165.6 (128.4, 215.2) | 166.5 (130.2, 216.1) | 164.7 (126.7, 215.2) | 142.6 (109.8, 191.3) | 144.4 (109.8, 194.0) | 142.6 (109.8, 188.7) | <.0001 |
| Lipid panel at end of active treatment period, median (IQR) | |||||||
| Total cholesterol (mg/dL) | 145.0 (123.7, 172.5) | 151.2 (129.9, 178.7) | 140.0 (119.9, 165.5) | 124.9 (107.1, 146.6) | 129.9 (111.4, 151.6) | 120.7 (104.0, 141.1) | <.0001 |
| LDL cholesterol (mg/dL) | 70.4 (54.1, 90.9) | 73.1 (56.5, 93.2) | 68.1 (52.6, 88.2) | 52.2 (39.4, 66.9) | 53.8 (40.6, 68.1) | 51.0 (38.3, 66.1) | <.0001 |
| HDL cholesterol (mg/dL) | 42.2 (36.0, 50.3) | 44.5 (37.5, 53.8) | 39.8 (34.8, 47.2) | 41.0 (34.8, 49.9) | 43.3 (36.0, 53.4) | 39.8 (34.0, 47.2) | <.0001 |
| Triglycerides (mg/dL) | 139.9 (106.3, 187.8) | 144.4 (109.8, 192.2) | 136.4 (102.7, 183.3) | 132.9 (99.2, 182.5) | 136.4 (102.7, 188.7) | 128.4 (97.4, 175.4) | <.0001 |
| Renal function, n (%) | <.0001 | ||||||
| Normal (eGFR ≥90 mL/min/1.73 m2) | 1468 (27.7) | 748 (28.2) | 720 (27.2) | 2464 (23.6) | 1214 (23.4) | 1250 (23.9) | |
| Mild impairment (eGFR ≥60-<90 mL/min/1.73 m2) | 2670 (50.3) | 1358 (51.1) | 1312 (49.5) | 5329 (51.1) | 2684 (51.6) | 2645 (50.6) | |
| Moderate impairment (eGFR ≥30-<60 mL/min/1.73 m2) | 1130 (21.3) | 531 (20.0) | 599 (22.6) | 2560 (24.6) | 1256 (24.2) | 1304 (24.9) | |
| Severe impairment (eGFR <30 mL/min/1.73 m2) | 29 (.5) | 15 (.6) | 14 (.5) | 62 (.6) | 39 (.8) | 23 (.4) | |
| Missing | 7 (.1) | 3 (.1) | 4 (.2) | 12 (.1) | 5 (.1) | 7 (.1) | |
Note: To convert the values for HDL cholesterol and LDL cholesterol to millimoles per liter, multiply by .02586. To convert the values for triglycerides to millimoles per liter, multiply by .01129.
Abbreviations: BMI, body mass index; eGFR, estimated glomerular filtration rate; IQR, interquartile range; HDL, high-density lipoprotein; LDL-C, low-density lipoprotein cholesterol; MI, myocardial infarction; NSTEMI, non-ST-segment elevation myocardial infarction; PCI, percutaneous coronary intervention; SD, standard deviation; STEMI, ST-segment elevation myocardial infarction.
aThe P-value is the Wilcoxon rank sum nonparametric for continuous χ2 tests for categorical in the comparison between total columns for LDL-C < 100 mg/dL compared with LDL-C ≥ 100 mg/dL.
bHigh-intensity statin therapy was derived based on reported use of atorvastatin ≥40 mg daily or rosuvastatin ≥20 mg daily.
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