Table 3.
Baseline characteristics. (not final data; data as of Feb 8, 2019)
| Characteristic | Randomized patients (N = 19 220)a |
|---|---|
| Age (years), median (IQR) | 66.0 (61.0‐72.0) |
| Male, n (%) | 13 189 (68.6) |
| BMI (kg/m2), median (IQR) | 29.0 (26.0‐32.7) |
| Current smoker, n (%) | 2094 (10.9) |
| Race, n (%) | |
| Asian | 4406 (22.9) |
| Black or African American | 403 (2.1) |
| Other | 715 (3.7) |
| White | 13 696 (71.3) |
| Geographic region, n (%) | |
| Asia and Australia | 4288 (22.3) |
| Central and South America | 2169 (11.3) |
| Europe, Middle East, and South Africa | 9768 (50.8) |
| North America | 2995 (15.6) |
| Disease history | |
| Hypertension, n (%) | 17 776 (92.5) |
| Dyslipidemia, n (%) | 16 753 (87.2) |
| Angina pectoris, n (%) | 10 801 (56.2) |
| Multi‐vessel coronary artery disease (>1 vessel), n (%) | 11 935 (62.1) |
| Revascularization status, n (%) | |
| Previous PCI only | 9808 (51.0) |
| Previous CABG only | 4191 (21.8) |
| Previous PCI and CABG | 1346 (7.0) |
| No previous revascularizationb | 3875 (20.2) |
| Time since most recent PCI (years), median (IQR) | 3.3 (1.5‐6.6) |
| Time since most recent CABG (years), median (IQR) | 4.3 (1.5‐9.2) |
| History of peripheral artery disease, n (%) | 1687 (8.8) |
| History of poly‐vascular diseasec, n (%) | 2579 (13.4) |
| Duration of diabetes (years), median (IQR) | 10.0 (5.0‐16.0) |
| History of any diabetes complicationsd, n (%) | 4910 (25.5) |
| HbA1c at baseline (%), median (IQR) | 7.1 (6.4‐8.1) |
| eGFR (MDRD) at baseline (mL/min/1.73 m2), median (IQR) | 75.0 (60.5‐89.6) |
| Medication use at baselinee | |
| Aspirin, n (%) | 19 104 (99.4) |
| Aspirin dose (mg), median (IQR) | 100 (80‐100) |
| Statin, n (%) | 17 266 (89.8) |
| Proton pump inhibitor, n (%) | 4901 (25.5) |
| ACE‐inhibitor or ARB, n (%) | 15 113 (78.6) |
| ACE‐inhibitor | 8145 (42.4) |
| ARB | 7211 (37.5) |
| Beta‐blocker, n (%) | 14 192 (73.8) |
| Insulin, n (%) | 5508 (28.7) |
| Any diabetes medications, n (%) | 19 156 (99.7) |
| 1 | 8609 (44.8) |
| 2 | 6911 (36.0) |
| 3 | 2892 (15.0) |
| >3 | 744 (3.9) |
Abbreviations: ACE, angiotensin‐converting enzyme; ARB, angiotensin receptor blocker; BMI, body mass index; CABG, coronary artery bypass grafting; CAD, coronary artery disease; eGFR, estimated glomerular filtration rate; HbA1c, glycated hemoglobin; IQR, interquartile range; MDRD, modification of diet in renal disease; PCI, percutaneous coronary intervention; PAD, peripheral artery disease.
N is the total number of randomized patients, patients that have been randomized more than once are only included according to their first randomization. Patients that are randomized but will not be included in the primary analysis are not included in this table;
significant stenosis on coronary angiography but no revascularization;
Defined as arterial obstructive disease involving at least 2 vascular beds where vascular bed involvement is characterized by either 1) CAD (defined as CAD, PCI or CABG), 2) PAD, 3) carotid artery stenosis or cerebral revascularization;
Defined as at least one of retinopathy, autonomic neuropathy, peripheral neuropathy, and nephropathy;
Medications used within 30 days of randomization, aspirin use is captured on day of randomization.