Table 4.
MACE at 90 days after PCI in the Danlou Tablet and placebo groups.
| Incidence | Treatment difference (%) | |||
|---|---|---|---|---|
| Danlou Tablet group | Placebo group | Difference of incidence (95% CI) | p value | |
| Full-analysis set | N = 109 | N = 110 | ||
| Total MACE, n (%) | 26 (23.9) | 41 (37.3) | 1.9 (1.1, 3.4) | 0.03c |
| Cardiac death, n (%) | 0 | 1 (0.9) | 1.00d | |
| Nonfatal MI, n (%) | 24 (22.0) | 38 (34.5) | 1.9 (1.0, 3.4) | 0.04c |
| Target vessel revascularization, n (%) | 2 (1.8) | 5 (4.5) | 2.5 (0.5, 13.4) | 0.45d |
| Rehospitalization due to CVEb, n (%) | 0 | 0 | ||
| Per-protocol analysis set | N = 105 | N = 103 | ||
| Total MACE, n (%) | 25 (23.8) | 35 (34.0) | 1.6 (0.9, 3.0) | 0.11c |
| Cardiac death, n (%) | 0 | 1 (1.0) | 0.50d | |
| Nonfatal MI, n (%) | 23 (21.9) | 32 (31.1) | 1.6 (0.9, 3.0) | 0.13c |
| Target vessel revascularization, n (%) | 2 (1.9) | 5 (4.9) | 2.6 (0.5, 13.9) | 0.28d |
| Rehospitalization due to CVEb, n (%) | 0 | 0 | ||
CI, confidence interval; CVE, cardiovascular events; MACE, major adverse cardiac event; and MI, myocardial infarction.
aDifference of incidence = Danlou Tablet − placebo.
bCardiovascular events included severe angina or heart failure (NYHF ⩾ IV).
c p value is from the continuity-adjusted Chi-square test.
d p value is from Fisher's exact test.