Table 1. Enrolled, Excluded, and Randomized Participant Baseline Characteristics.
| Characteristic | No./Total No. (%) | ||
|---|---|---|---|
| Enrolled (n = 8518) | Excluded (n = 3339) | Randomized (n = 5179) | |
| Demographics | |||
| Age at enrollment, y | |||
| No. | 8518 | 3339 | 5179 |
| Median (IQR) | 63 (57-70) | 62 (55-68) | 64 (58-70) |
| Female | 2262/8518 (26.6) | 1094/3339 (32.8) | 1168/5179 (22.6) |
| Race | |||
| American Indian or Alaskan Native | 20/8433 (0.2) | 7/3304 (0.2) | 13/5129 (0.3) |
| Asian | 2568/8433 (30.5) | 1083/3304 (32.8) | 1485/5129 (29.0) |
| Native Hawaiian or other Pacific Islander | 19/8433 (0.2) | 7/3304 (0.2) | 12/5129 (0.2) |
| Black or African American | 410/8433 (4.9) | 206/3304 (6.2) | 204/5129 (4.0) |
| White | 5395/8433 (64.0) | 1992/3304 (60.3) | 3403/5129 (66.3) |
| Multiple races reported | 21/8433 (0.2) | 9/3304 (0.3) | 12/5129 (0.2) |
| Ethnicity | |||
| Hispanic or Latino | 1102/7924 (13.9) | 354/3109 (11.4) | 748/4815 (15.5) |
| Not Hispanic or Latino | 6822/7924 (86.1) | 2755/3109 (88.6) | 4067/4815 (84.5) |
| Clinical history | |||
| Hypertension | 6031/8474 (71.2) | 2242/3313 (67.7) | 3789/5161 (73.4) |
| Diabetes | 3128/8517 (36.7) | 1006/3338 (30.1) | 2122/5179 (41.0) |
| Prior myocardial infarction | 1354/8419 (16.1) | 364/3258 (11.2) | 990/5161 (19.2) |
| Cigarette smoking | |||
| Never | 3903/8276 (47.2) | 1694/3103 (54.6) | 2209/5173 (42.7) |
| Former | 3327/8276 (40.2) | 1002/3103 (32.3) | 2325/5173 (44.9) |
| Current | 1046/8276 (12.6) | 407/3103 (13.1) | 639/5173 (12.4) |
| Laboratory values | |||
| Estimated GFR from enrollment, mL/min | |||
| No. | 8518 | 3339 | 5179 |
| Median (IQR) | 82 (69-97) | 83 (72-98) | 81 (67-97) |
| Baseline ECG core laboratory interpretation | |||
| Q waves: meets UMI criteriaa | 555/4769 (11.6) | NA | 555/4769 (11.6) |
| ST-segment depression ≥0.5mmb | 514/4922 (10.4) | NA | 514/4922 (10.4) |
| T-wave inversion ≥1 mm | 399/4923 (8.1) | NA | 399/4923 (8.1) |
| Qualifying stress test core laboratory interpretation | |||
| Ischemia severity by imaging modality | |||
| Stress imaging overall | 5940/8517 (69.7) | 2031/3338 (60.8) | 3909/5179 (75.5) |
| Severity | |||
| Severe | 2279/5897 (38.6) | 531/1996 (26.6) | 1748/3901 (44.8) |
| Moderate | 2178/5897 (36.9) | 578/1996 (29.0) | 1600/3901 (41.0) |
| Mild | 812/5897 (13.8) | 495/1996 (24.8) | 317/3901 (8.1) |
| None | 607/5897 (10.3) | 381/1996 (19.1) | 226/3901 (5.8) |
| Uninterpretable | 21/5897 (0.4) | 11/1996 (0.6) | 10/3901 (0.3) |
| Exercise tolerance test | 2577/8517 (30.3) | 1307/3338 (39.2) | 1270/5179 (24.5) |
| Severity | |||
| Severe | 1715/2441 (70.3) | 664/1175 (56.5) | 1051/1266 (83.0) |
| Moderate | 345/2441 (14.1) | 244/1175 (20.8) | 101/1266 (8.0) |
| Mild | 109/2441 (4.5) | 75/1175 (6.4) | 34/1266 (2.7) |
| None | 108/2441 (4.4) | 80/1175 (6.8) | 28/1266 (2.2) |
| Uninterpretable | 164/2441 (6.7) | 112/1175 (9.5) | 52/1266 (4.1) |
| Nuclear | 3843/8517 (45.1) | 1276/3338 (38.2) | 2567/5179 (49.6) |
| Severity | |||
| Severe | 1177/3817 (30.8) | 207/1254 (16.5) | 970/2563 (37.8) |
| Moderatec | 1588/3817 (41.6) | 386/1254 (30.8) | 1202/2563 (46.9) |
| Mild | 565/3817 (14.8) | 352/1254 (28.1) | 213/2563 (8.3) |
| None | 468/3817 (12.3) | 298/1254 (23.8) | 170/2563 (6.6) |
| Uninterpretable | 19/3817 (0.5) | 11/1254 (0.9) | 8/2563 (0.3) |
| Echo | 1784/8517 (20.9) | 699/3338 (20.9) | 1085/5179 (20.9) |
| Severity | |||
| Severe | 926/1769 (52.3) | 300/688 (43.6) | 626/1081 (57.9) |
| Moderatec | 500/1769 (28.3) | 184/688 (26.7) | 316/1081 (29.2) |
| Mild | 218/1769 (12.3) | 130/688 (18.9) | 88/1081 (8.1) |
| None | 123/1769 (7.0) | 74/688 (10.8) | 49/1081 (4.5) |
| Uninterpretable | 2/1769 (0.1) | 0/688 (0.0) | 2/1081 (0.2) |
| CMR | 313/8517 (3.7) | 56/3338 (1.7) | 257/5179 (5.0) |
| Severity | |||
| Severe | 176/311 (56.6) | 24/54 (44.4) | 152/257 (59.1) |
| Moderate | 90/311 (28.9) | 8/54 (14.8) | 82/257 (31.9) |
| Mild | 29/311 (9.3) | 13/54 (24.1) | 16/257 (6.2) |
| None | 16/311 (5.1) | 9/54 (16.7) | 7/257 (2.7) |
| Uninterpretable | 0/311 (0.0) | 0/54 (0.0) | 0/257 (0.0) |
| CCTA findingsd | |||
| Any obstructive disease ≥50% stenosis by CCTA | 4672/5402 (86.5) | 840/1566 (53.6) | 3832/3836 (99.9) |
| Multivessel disease ≥50% stenosis by CCTA | 3348/5111 (65.5) | 669/1721 (38.9) | 2679/3390 (79.0) |
| Vessels ≥50% stenosis by CCTA | |||
| 0 | 730/4375 (16.7) | 726/1389 (52.3) | 4/2986 (0.1) |
| 1 | 785/4375 (17.9) | 88/1389 (6.3) | 697/2986 (23.3) |
| 2 | 1081/4375 (24.7) | 143/1389 (10.3) | 938/2986 (31.4) |
| ≥3 | 1779/4375 (40.7) | 432/1389 (31.1) | 1347/2986 (45.1) |
| Specific native vessels with ≥50% stenosis by CCTA | |||
| Left main | 501/5757 (8.7) | 461/1912 (24.1) | 40/3845 (1.0) |
| Left anterior descending | 3893/5417 (71.9) | 703/1740 (40.4) | 3190/3677 (86.8) |
| Proximal LAD | 2248/5633 (39.9) | 499/1894 (26.3) | 1749/3739 (46.8) |
| Left circumflex | 2889/5172 (55.9) | 535/1677 (31.9) | 2354/3495 (67.4) |
| Right coronary artery | 2844/4956 (57.4) | 533/1597 (33.4) | 2311/3359 (68.8) |
Abbreviations: CCTA, coronary computed tomographic angiography; CMR, cardiac magnetic resonance; ECG, electrocardiogram; ETT, exercise tolerance test; GFR, glomerular filtration rate; IQR, interquartile range; LAD, left anterior descending; MI, myocardial infarction; NA, not applicable; UMI, universal definition of myocardial infarction.
Meets universal definition of MI in 2 leads in at least 1 territory (anterior, inferior, or lateral).
Protocol criteria to enter through the ETT pathway required absence of resting ST-segment depression of at least 1 mm at the time of ETT. The baseline prerandomization ECG was not always acquired on the day of the ETT.
The determination of moderate ischemia by the core laboratory included ancillary criteria (eg, heart rate and workload) for 26 randomized and 4 excluded participants who were enrolled after stress nuclear and for 30 randomized and 6 excluded participants who were enrolled after stress echocardiography.
Includes study and nonstudy CCTAs. Enrolled participants with study CCTA: 5757. Enrolled participants with nonstudy CCTA: 148. Randomized participants with any study or nonstudy CCTA: 3912. These numbers represent 50% stenosis criteria for all stress test modalities, in contrast to the Figure, which shows excluded participants based on those who did not meet the differential 50% and 70% stenosis criteria for imaging and nonimaging stress tests, respectively.