Table 2.
Randomized to MED | Randomized to CABG | |||||
---|---|---|---|---|---|---|
Rec. MED (per protocol) (n=537) | Rec. CABG (crossover) (n=65) | P | Rec. MED (crossover) (n=55) | Rec. CABG (per protocol) (n=555) | p | |
Age (years) | 59(54, 67) | 57 (51, 65) | 0.170 | 61 (57, 69) | 60 (54, 68) | 0.237 |
Women (%) | 11.9% | 16.9% | 0.249 | 10.9% | 12.1% | 0.800 |
White (%) | 70.2% | 66.2% | 0.502 | 61.8% | 67.2% | 0.419 |
Black or other(%) | 29.8% | 33.8% | 38.2% | 32.8% | ||
Body mass index, median (kg/m2) | 27 (24, 30) | 26 (24, 29) | 0.842 | 26 (24, 29) | 27(24, 30) | 0.226 |
Medical history(%) | ||||||
Myocardial infarction | 78.4% | 78.5% | 0.991 | 74.5% | 75.9% | 0.829 |
Hyperlipidemia | 61.5% | 62.5% | 0.871 | 47.3% | 60.3% | 0.061 |
Hypertension | 62.6% | 52.3% | 0.108 | 50.9% | 59.5% | 0.219 |
Diabetes | 40.8% | 29.2% | 0.072 | 40.0% | 39.3% | 0.917 |
Current smoker | 19.2% | 29.2% | 0.058 | 27.3% | 20.7% | 0.258 |
Previous percutaneous coronary intervention | 12.3% | 12.3% | 0.997 | 21.8% | 12.6% | 0.056 |
Chronic renal Insufficiency | 7.8% | 4.6% | 0.460 | 14.5% | 7.4% | 0.071 |
Stroke | 6.7% | 7.7% | 0.793 | 5.5% | 8.6% | 0.609 |
PVD | 14.2% | 29.2% | 0.002 | 10.9% | 15.0% | 0.418 |
Previous CABG | 2.6% | 0.0% | 0.383 | 10.9% | 2.9% | 0.010 |
Current CCS angina class | ≤0.0014 | 0.255 | ||||
No angina | 39.5% | 20.0% | 29.1% | 36.2% | ||
I | 15.5% | 12.3% | 16.4% | 15.7% | ||
| ||||||
II | 41.2% | 60.0% | 47.3% | 43.1% | ||
III / IV | 4.0% | 7.7% | 7.2% | 5.0% | ||
| ||||||
Current NYHA heart failure class | 0.003 | 0.069 | ||||
I | 13.0% | 6.2% | 9.1% | 10.8% | ||
II | 52.3% | 40.0% | 41.8% | 53.3% | ||
III / IV | 34.6% | 53.9% | 49.1% | 35.9% | ||
Systolic blood pressure, median mm Hg | 120 (110, 130) | 120 (110, 130) | 0.224 | 120 (110, 140) | 120 (110, 130) | 0.836 |
Pulse, median beats/min | 72 (65, 80) | 74 (68, 80) | 0.858 | 72 (65, 84) | 74 (66, 82) | 0.502 |
Able to perform 6-minute walk | 89.2% | 92.2% | 0.455 | 72.2% | 84.7% | 0.019 |
6-minute walk distance, median ft | 1139 (878, 1348) | 984 (738, 1247) | 0.024 | 984 (853, 1290) | 1148 (875, 1325) | 0.356 |
No. diseased vessels (≥ 75%) | 0.648 | 0.859 | ||||
≤1 | 26.1% | 29.3% | 26.0% | 24.2% | ||
2 | 38.4% | 35.4% | 37.0% | 38.4% | ||
3 | 35.6% | 35.4% | 37.0% | 37.5% | ||
Proximal LAD≥ 75% | 68.7% | 70.8% | 0.735 | 61.1% | 68.1% | 0.295 |
LVEF (site-reported) | 27 (22, 30) | 30 (25, 33) | 0.003 | 27 (24, 31) | 27 (22, 31) | 0.993 |
LVEF (core lab + site) | 28 (21, 34) | 27 (23, 32) | 0.579 | 25 (19, 33) | 27 (22, 33) | 0.306 |
| ||||||
LVESVI (core lab + site) | 79 (58, 108) | 78 (64, 95) | 0.888 | 92 (73, 111) | 78 (61, 101) | 0.036 |
| ||||||
Mitral regurgitation (site-reported) | 0.333 | 0.446 | ||||
None or trace | 38.0% | 29.2% | 27.3% | 35.7% | ||
Mild | 42.5% | 52.3% | 49.1% | 47.9% | ||
Moderate (3+) | 16.7% | 13.8% | 18.2% | 13.2% | ||
Severe (4+) | 2.8% | 4.6% | 5.5% | 3.2% | ||
RAR score | 11 (5, 20) | 10 (5, 17) | 0.588 | 12 (7, 20) | 11 (5, 19) | 0.136 |
Data shown are median and inter-quartile range or proportions as a percentage.