Table 1. Patient Characteristics Stratified by Baseline LDL-C Level and Background Statin Intensitya.
| Characteristic | Baseline LDL-C Level, mg/dL (N = 27 563)b |
P Value | Baseline Statin Potency (N = 27 564) |
P Value | ||
|---|---|---|---|---|---|---|
| <70 (n = 2034)c |
≥70 (n = 25 529) |
Maximald (n = 7533) |
Submaximal (n = 20 031) |
|||
| Age, mean (SD), y | 62.1 (9.2) | 62.5 (9.0) | .051 | 61.1 (8.9) | 63.0 (9.0) | <.001 |
| Weight, mean (SD), kg | 88.2 (18.2) | 85.0 (17.2) | <.001 | 88.2 (17.6) | 84.2 (17.2) | <.001 |
| Male | 1632 (80.2) | 19 162 (75.1) | <.001 | 5722 (76.0) | 15 073 (75.2) | .22 |
| White racee | 1708 (84.0) | 21 749 (85.2) | .14 | 7027 (93.3) | 16 431 (82.0) | <.001 |
| Region | ||||||
| North America | 348 (17.1) | 4223 (16.5) | <.001 | 1877 (24.9) | 2694 (13.4) | <.001 |
| Europe | 1226 (60.3) | 16 108 (63.1) | 4862 (64.5) | 12 473 (62.3) | ||
| Latin America | 178 (8.8) | 1645 (6.4) | 180 (2.4) | 1643 (8.2) | ||
| Asia, Pacific, South Africa | 282 (13.9) | 3553 (13.9) | 614 (8.2) | 3221 (16.1) | ||
| Type of atherosclerosisf | ||||||
| Myocardial infarction | 1591 (78.2) | 20 759 (81.3) | <.001 | 6499 (86.3) | 15 852 (79.1) | <.001 |
| Nonhemorrhagic stroke | 430 (21.1) | 4907 (19.2) | .04 | 1182 (15.7) | 4155 (20.7) | <.001 |
| Peripheral artery disease | 276 (13.6) | 3366 (13.2) | .62 | 1012 (13.4) | 2630 (13.1) | .51 |
| Cardiovascular risk factors | ||||||
| Hypertension | 1673 (82.3) | 20 410 (80.0) | .01 | 6019 (79.9) | 16 065 (80.2) | .57 |
| Diabetes | 987 (48.5) | 9093 (35.6) | <.001 | 2536 (33.7) | 7545 (37.7) | <.001 |
| Metabolic syndrome | 1481 (72.8) | 14 869 (58.2) | <.001 | 4501 (59.8) | 11 850 (59.2) | .38 |
| Current cigarette use | 544 (26.7) | 7232 (28.3) | .13 | 2067 (27.4) | 5710 (28.5) | .08 |
| TIMI Risk Score for secondary prevention, mean (SD)g | 3.4 (1.2) | 3.3 (1.2) | <.001 | 3.3 (1.3) | 3.3 (1.2) | .002 |
| Statin intensity at baselineh | .02 | |||||
| High | 1365 (67.1) | 17 737 (69.5) | NA | 7533 (100) | 11 570 (57.8) | NA |
| Atorvastatin calcium, 80 mg/d, or rosuvastatin, 40 mg/d | 524 (25.8) | 7008 (27.5) | .10 | 7533 (100) | 0 | NA |
| Moderate | 667 (32.8) | 7725 (30.3) | NA | 0 | 8392 (41.9) | NA |
| Low, unknown, or no data | 2 (0.1) | 67 (0.3) | NA | 0 | 69 (0.3) | NA |
| Ezetimibe treatment | 83 (4.1) | 1357 (5.3) | .02 | 672 (8.9) | 768 (3.8) | <.001 |
| Other cardiovascular medicationsi | ||||||
| Aspirin and/or P2Y12 inhibitor | 1875 (92.2) | 23 556 (92.4) | .77 | 7122 (94.6) | 18 310 (91.5) | <.001 |
| β-Blocker | 1582 (77.8) | 19 232 (75.4) | .02 | 6056 (80.4) | 14 759 (73.8) | <.001 |
| Renin-angiotensin-aldosterone inhibitor | 1626 (79.9) | 19 906 (78.1) | .047 | 6016 (79.9) | 15 517 (77.5) | <.001 |
| Lipid levels, median (IQR), mg/dL | ||||||
| LDL-C | 65.5 (61.0-68.0) | 93.5 (82.0. 110.5) | NA | 93.0 (80.0-111.5) | 91.0 (79.5-107.5) | <.001 |
| Total cholesterol | 141.0 (132.0-152.0) | 170.0 (153.5-190.5) | NA | 168.0 (150.5-190.5) | 167.0 (151.0-187.5) | .004 |
| HDL-C | 38.5 (32.5. 47.0) | 44.0 (37.5-52.5) | NA | 43.0 (36.5-51.5) | 44.0 (37.0-53.0) | <.001 |
| Triglycerides | 181.0 (115.0-252.0) | 131.0 (99.5-177.0) | NA | 133.0 (98.5-181.0) | 133.0 (100.0-182.0) | .19 |
| LDL-C level <70 mg/dL at baseline | 2034 (100) | 0 | NA | 524 (7.0) | 1510 (7.5) | .10 |
Abbreviations: HDL-C, high-density lipoprotein cholesterol; IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol; NA not applicable; TIMI, Thrombolysis in Myocardial Infarction.
SI conversion factors: To convert cholesterol to millimoles per liter, multiply by 0.0259; triglycerides to millomoles per liter, multiply by 0.0113.
Unless otherwise indicated, data are expressed as number (percentage) of patients. Percentages have been rounded and may not total 100. We found no nominally significant differences between the randomized treatments in either group stratified by baseline LDL-C level or stratified by baseline maximal statin potency except for baseline triglyceride in the submaximal statin intensity subgroup (P = .05).
Baseline LDL-C data were not available for 1 patient.
These patients either had a final screening LDL-C of at least 70 mg/dL or a final screening non–HDL-C level of at least 100 mg/dL.
Maximal statin potency indicates atorvastatin calcium, 80 mg/d, or rosuvastatin, 40 mg/d. All other statin regimens were considered to be submaximal.
Reported by the patients.
Patients could have more than 1 type of atherosclerosis.
As described by Bohula et al, scores range from 0 to 9, with higher scores indicating higher risk.
Categorized in accordance with the guidelines of the American College of Cardiology and American Heart Association.
Owing to missing patient data, denominators may be less than column headings.