Table 3.
Pre-specified Primary Quality of Life Measures as Randomized in the PROMISE Trial.
| Anatomic (N=2982) |
Functional (N=3003) |
Difference Between Anatomic and Functional (95% CI) |
|
|---|---|---|---|
| Duke Activity Status Index (DASI) | |||
| 0-58.2 scale; 0=worst, 58.2=best | |||
| Baseline | |||
| Number of patients | 2923 | 2918 | |
| Median (Q1, Q3) | 21.5 (10.7, 38.2) | 22.9 (10.0, 39.5) | |
| Mean (standard deviation) | 25.5 (17.7) | 25.5 (17.8) | |
| 6 month | |||
| Number of patients | 2677 | 2563 | |
| Median (Q1, Q3) | 30.5 (14.8, 44.7) | 30.2 (15.2, 44.7) | |
| Mean (standard deviation) | 30.4 (17.8) | 30.5 (17.7) | −0.1 (−1.0 to 0.8) |
| 12 month | |||
| Number of patients | 2593 | 2396 | |
| Median (Q1, Q3) | 29.2 (13.5, 44.7) | 31.2 (15.2, 44.7) | |
| Mean (standard deviation) | 29.9 (17.8) | 30.7 (17.7) | −0.6 (−1.6 to 0.3) |
| 24 month | |||
| Number of patients | 2247 | 2002 | |
| Median (Q1, Q3) | 31.5 (16.0, 45.5) | 31.2 (16.0, 45.5) | |
| Mean (standard deviation) | 31.2 (17.4) | 31.1 (17.4) | 0.1 (−0.9 to 1.1) |
| Seattle Angina Questionnaire | |||
| Angina Frequency Scale | |||
| Higher scores = less frequent angina | |||
| Baseline | |||
| Number of patients | 2929 | 2933 | |
| Median (Q1, Q3) | 80 (70, 90) | 80 (70, 90) | |
| Mean (standard deviation) | 78.5 (16.9) | 78.2 (17.2) | |
| 6 month | |||
| Number of patients | 2726 | 2648 | |
| Median (Q1, Q3) | 100 (90, 100) | 100 (90, 100) | |
| Mean (standard deviation) | 93.1 (12.1) | 92.9 (13.1) | 0.2 (−0.4 to 0.9) |
| 12 month | |||
| Number of patients | 2672 | 2525 | |
| Median (Q1, Q3) | 100 (90, 100) | 100 (90, 100) | |
| Mean (standard deviation) | 94.0 (11.8) | 94.1 (11.6) | −0.1 (−0.7 to 0.5) |
| 24 month | |||
| Number of patients | 2413 | 2218 | |
| Median (Q1, Q3) | 100 (100, 100) | 100 (100, 100) | |
| Mean (standard deviation) | 95.0 (11.2) | 95.1 (10.8) | −0.2 (−0.8 to 0.4) |
| Quality of Life Scale | |||
| 0-100 scale with higher scores representing
better quality of life |
|||
| Baseline Number of patients Median (Q1, Q3) Mean (standard deviation) |
2866 58.3 (41.7, 75.0) 56.3 (22.7) |
2884 58.3 (41.7, 75.0) 56.0 (22.8) |
|
| 6 month Number of patients Median (Q1, Q3) Mean (standard deviation) |
2685 83.3 (75.0, 91.7) 80.4 (19.7) |
2581 83.3 (75.0, 100) 80.6 (20.1) |
−0.2 (−1.2 to 0.9) |
| 12 month | |||
| Number of patients | 2563 | 2387 | |
| Median (Q1, Q3) | 83.3 (75.0, 100) | 91.7 (75.0, 100) | |
| Mean (standard deviation) | 81.7 (19.1) | 82.4 (18.8) | −0.5 (−1.5 to 0.6) |
| 24 month | |||
| Number of patients | 2201 | 1997 | |
| Median (Q1, Q3) | 91.7 (75.0, 100) | 91.7 (75.0, 100) | |
| Mean (standard deviation) | 82.8 (18.8) | 83.0 (18.6) | −0.2 (−1.3 to 0.9) |
| Physical Limitation Score | |||
| 0-100 scale with higher scores representing
better physical functioning |
|||
| Baseline | |||
| Number of patients | 2814 | 2801 | |
| Median (Q1, Q3) | 86.1 (66.7, 97.2) | 86.1 (66.7, 97.2) | |
| Mean (standard deviation) | 78.6 (21.5) | 79.1 (22.0) | |
| 6 month | |||
| Number of patients | 2403 | 2297 | |
| Median (Q1, Q3) | 100.0 (94.4, 100) | 100.0 (94.4, 100) | |
| Mean (standard deviation) | 93.6 (14.6) | 94.0 (13.9) | −0.4 (−1.2 to 0.4) |
| 12 month | |||
| Number of patients | 2282 | 2141 | |
| Median (Q1, Q3) | 100 (97.2, 100) | 100 (97.2, 100) | |
| Mean (standard deviation) | 94.3 (14.1) | 95.0 (12.4) | −0.8 (−1.6 to -0.0) |
| 24 month | |||
| Number of patients | 1810 | 1986 | |
| Median (Q1, Q3) | 100 (97.2, 100) | 100 (100, 100) | |
| Mean (standard deviation) | 95.3 (12.1) | 94.8 (13.2) | −0.7 (−1.5 to 0.1) |
| Angina Stability | |||
| 0-100 scale, lower scores indicate more
frequent angina, higher scores less frequent angina, a score of 50 indicates no change in angina frequency at most strenuous level of activity |
|||
| Baseline | |||
| Number of patients | 2903 | 2909 | |
| Median (Q1, Q3) | 50.0 (25.0, 50.0) | 50.0 (25.0, 50.0) | |
| Mean (standard deviation) | 44.2 (23.9) | 43.8 (25.2) | |
| 6 month | |||
| Number of patients | 2716 | 2640 | |
| Median (Q1, Q3) | 50.0 (50.0, 50.0) | 50.0 (50.0, 50.0) | |
| Mean (standard deviation) | 54.4 (16.5) | 53.7 (15.5) | 0.7 (−0.1 to 1.6) |
| 12 month | |||
| Number of patients | 2666 | 2518 | |
| Median (Q1, Q3) | 50.0 (50.0, 50.0) | 50.0 (50.0, 50.0) | |
| Mean (standard deviation) | 52.2 (14.5) | 52.8 (14.8) | −0.7 (−1.5 to 0.1) |
| 24 month | |||
| Number of patients | 2406 | 2217 | |
| Median (Q1, Q3) | 50.0 (50.0, 50.0) | 50.0 (50.0, 50.0) | |
| Mean (standard deviation) | 95.0 (12.9) | 51.3 (12.0) | −0.1 (−0.8 to 0.6) |
| Treatment Satisfaction | |||
| 0-100 scale with higher scores indicating more
satisfaction with treatment |
|||
| Baseline | |||
| Number of patients | 2810 | 2819 | |
| Median (Q1, Q3) | 91.7 (75.0, 100) | 91.7 (75.0, 100) | |
| Mean (standard deviation) | 83.7 (20.6) | 83.4 (20.3) | |
| 6 month | |||
| Number of patients | 2667 | 2556 | |
| Median (Q1, Q3) | 100 (83.3, 100) | 100 (83.3, 100) | |
| Mean (standard deviation) | 89.4 (18.6) | 88.2 (20.9) | 1.4 (0.3 to 2.4) |
| 12 month | |||
| Number of patients | 2547 | 2367 | |
| Median (Q1, Q3) | 100 (83.3, 100) | 100 (83.3, 100) | |
| Mean (standard deviation) | 89.4 (18.4) | 88.7 (20.0) | 1.0 (−0.1 to 2.1) |
| 24 month | |||
| Number of patients | 2163 | 1939 | |
| Median (Q1, Q3) | 100 (83.3, 100) | 100 (83.3, 100) | |
| Mean (standard deviation) | 89.8 (17.6) | 89.4 (18.6) | 1.0 (−0.1 to 2.1) |
Continuous variables shown as medians (Q1, Q3) and means with standard deviations. 95% confidence intervals on treatment differences calculated as CTA minus functional testing.