Table 1.
Baseline characteristics overall and by diabetes status
| Characteristic | All Participants (N=5,900) |
No Diabetes at Baseline (N=3,347) |
Diabetes at Baseline (N=2,553) |
P-value |
|---|---|---|---|---|
| Demographics | ||||
| Age at Randomization (years), Median (Q1, Q3) | 64 (57, 70) | 64 (57, 71) | 64 (58, 70) | 0.981 |
| Female sex | 1,394/5,900 (23.6%) | 765/3,347 (22.9%) | 629/2,553 (24.6%) | 0.111 |
| Race | <.001 | |||
| American Indian or Alaskan Native | 18/5,820 (0.3%) | 9/3,318 (0.3%) | 9/2,502 (0.4%) | |
| Asian | 1,647/5,820 (28.3%) | 837/3,318 (25.2%) | 810/2,502 (32.4%) | |
| Native Hawaiian or Other Pacific Islander | 16/5,820 (0.3%) | 6/3,318 (0.2%) | 10/2,502 (0.4%) | |
| Black or African American | 265/5,820 (4.6%) | 103/3,318 (3.1%) | 162/2,502 (6.5%) | |
| White | 3,861/5,820 (66.3%) | 2,356/3,318 (71.0%) | 1,505/2,502 (60.2%) | |
| Multiple Races Reported | 13/5,820 (0.2%) | 7/3,318 (0.2%) | 6/2,502 (0.2%) | |
| Hispanic or Latino ethnicity | 858/5,496 (15.6%) | 447/3,145 (14.2%) | 411/2,351 (17.5%) | <.001 |
| Diabetes Treatment | ||||
| Insulin Treated | 771/2,553 (30.2%) | - | 771/2,553 (30.2%) | |
| Non-Insulin Diabetes Medication | 1,447/2,553 (56.7%) | - | 1,447/2,553 (56.7%) | |
| None/Diet Controlled | 335/2,553 (13.1%) | - | 335/2,553 (13.1%) | |
| Cigarette Smoking | <.001 | |||
| Never Smoked | 2,555/5,895 (43.3%) | 1,376/3,345 (41.1%) | 1,179/2,550 (46.2%) | |
| Former Smoker | 2,626/5,895 (44.5%) | 1,500/3,345 (44.8%) | 1,126/2,550 (44.2%) | |
| Current Smoker | 714/5,895 (12.1%) | 469/3,345 (14.0%) | 245/2,550 (9.6%) | |
| Clinical History | ||||
| Hypertension | 4,462/5,878 (75.9%) | 2,357/3,331 (70.8%) | 2,105/2,547 (82.6%) | <.001 |
| Baseline Hemoglobin % A1c , N | 3856 | 1526 | 2330 | |
| Median (Q1, Q3) | 6 (6, 8) | 6 (6, 6) | 7 (7, 8) | <.001 |
| Prior Myocardial Infarction | 1,109/5,882 (18.9%) | 618/3,338 (18.5%) | 491/2,544 (19.3%) | 0.445 |
| Prior Percutaneous Coronary Intervention (PCI) | 1,183/5,896 (20.1%) | 642/3,344 (19.2%) | 541/2,552 (21.2%) | 0.057 |
| Prior Coronary Artery Bypass Graft (CABG) | 229/5,900 (3.9%) | 110/3,347 (3.3%) | 119/2,553 (4.7%) | 0.007 |
| Prior MI or Prior PCI or Prior CABG | 1,775/5,882 (30.2%) | 966/3,337 (28.9%) | 809/2,545 (31.8%) | 0.019 |
| eGFR among Patients not on Dialysis at Baseline, N | 5485 | 3153 | 2332 | |
| Median eGFR ml/min/1.732 (Q1, Q3) | 80 (64, 95) | 81 (66, 96) | 78 (60, 94) | <.001 |
| eGFR ml/min/1.73 m2 | <.001 | |||
| ≥60 | 4,396/5,900 (74.5%) | 2,642/3,347 (78.9%) | 1,754/2,553 (68.7%) | |
| 30–59 | 735/5,900 (12.5%) | 372/3,347 (11.1%) | 363/2,553 (14.2%) | |
| <30 or on dialysis | 769/5,900 (13.0%) | 333/3,347 (9.9%) | 436/2,553 (17.1%) | |
| On Dialysis at Baseline | 415/5,900 (7.0%) | 194/3,347 (5.8%) | 221/2,553 (8.7%) | <.001 |
| Non-Cardiac Vascular and Comorbidity History | ||||
| Prior Carotid Artery Surgery or Stent, Stroke, or Transient Ischemic Attack (TIA) | 474/5,887 (8.1%) | 232/3,340 (6.9%) | 242/2,547 (9.5%) | <.001 |
| Prior Stroke | 217/5,899 (3.7%) | 92/3,346 (2.7%) | 125/2,553 (4.9%) | <.001 |
| Prior Peripheral Vascular Disease (PAD) or Surgery or Percutaneous Procedure for PAD | 250/5,891 (4.2%) | 113/3,343 (3.4%) | 137/2,548 (5.4%) | <.001 |
| Angina & Heart Failure History | ||||
| Baseline Seattle Angina Questionnaire Angina Frequency Scale, N | 5,323 | 3,079 | 2,244 | |
| Median (25th, 75th) | 90 (70, 100) | 90 (70, 100) | 90 (70, 100) | 0.010 |
| Baseline Seattle Angina Questionnaire Angina Frequency Scale | 0.007 | |||
| Daily Angina (0–30) | 127/5,323 (2.4%) | 72/3,079 (2.3%) | 55/2,244 (2.5%) | |
| Weekly Angina (31–60) | 900/5,323 (16.9%) | 553/3,079 (18.0%) | 347/2,244 (15.5%) | |
| Monthly Angina (61–99) | 2,322/5,323 (43.6%) | 1,367/3,079 (44.4%) | 955/2,244 (42.6%) | |
| No Angina in Past Month (100) | 1,974/5,323 (37.1%) | 1,087/3,079 (35.3%) | 887/2,244 (39.5%) | |
| Participant Has Ever Had Angina | 5,179/5,900 (87.8%) | 2,984/3,347 (89.2%) | 2,195/2,553 (86.0%) | <.001 |
| New Onset of Angina Over the Past 3 Months | 966/5,610 (17.2%) | 570/3,174 (18.0%) | 396/2,436 (16.3%) | 0.094 |
| Left ventricular systolic dysfunction (LVEF ≥35%<45%) | 306/5,895 (5.2%) | 149/3,344 (4.5%) | 157/2,551 (6.2%) | 0.004 |
| Ejection Fraction*, N | 5,206 | 2,944 | 2,262 | |
| Median (25th, 75th) | 60 (55, 65) | 60 (55, 65) | 60 (54, 65) | <.001 |
| Guideline Directed Medical Therapy† | ||||
| LDL cholesterol < 70 mg/dL and on any statin | 1,815/5,615 (32.3%) | 861/3,201 (26.9%) | 954/2,414 (39.5%) | <.001 |
| Systolic blood pressure < 140 mmHg | 3,753/5,873 (63.9%) | 2,240/3,331 (67.2%) | 1,513/2,542 (59.5%) | <.001 |
| Aspirin or other anti-platelet or anti-coagulant | 5,579/5,897 (94.6%) | 3,165/3,345 (94.6%) | 2,414/2,552 (94.6%) | 0.965 |
| Non-smoker | 5,181/5,895 (87.9%) | 2,876/3,345 (86.0%) | 2,305/2,550 (90.4%) | <.001 |
*
Site-reported value, if available. If not available, then core-lab entered value;
†
,ISCHEMIA definition of optimal medical therapy.11