Table 3.
Efficacy endpoints according to time-to-treatment initiation (N = 4661, colchicine vs. placebo)
| Endpoints | TTI 0–3 days, N = 1193 | TTI 4–7 days, N = 720 | TTI ≥ 8 days, N = 2748 |
|---|---|---|---|
| Colchicine vs. placebo, no. (%) | Colchicine vs. placebo, no. (%) | Colchicine vs. placebo, no. (%) | |
| HR (95% CI); P | HR (95% CI); P | HR (95% CI); P | |
| Primary composite endpoint | 26 (4.3%) vs. 49 (8.3%) | 22 (6.0%) vs. 21 (5.9%) | 77 (5.7%) vs. 99 (7.1%) |
| 0.52 (0.32–0.84); P = 0.007 | 0.96 (0.53–1.75); P = 0.896 | 0.82 (0.61–1.11); P = 0.200 | |
| CV death | 2 (0.3%) vs. 2 (0.3%) | 2 (0.5%) vs. 4 (1.1%) | 15 (1.1%) vs. 18 (1.3%) |
| 1.04 (0.15–7.37); P = 0.970 | 0.45 (0.08–2.46); P = 0.356 | 0.89 (0.45–1.76); P = 0.734 | |
| Resuscitated cardiac arrest | 1 (0.2%) vs. 3 (0.5%) | 2 (0.5%) vs. 1 (0.3%) | 2 (0.1%) vs. 2 (0.1%) |
| 0.33 (0.03–3.20); P = 0.340 | 1.90 (0.17–20.95); P = 0.600 | 1.02 (0.14–7.22); P = 0.986 | |
| MI | 17 (2.8%) vs. 29 (4.9%) | 16 (4.4%) vs. 9 (2.5%) | 52 (3.8%) vs. 59 (4.2%) |
| 0.58 (0.32–1.05); P = 0.071 | 1.67 (0.74–3.78); P = 0.218 | 0.93 (0.64–1.35); P = 0.710 | |
| Stroke | 1 (0.2%) vs. 5 (0.8%) | 1 (0.3%) vs. 3 (0.8%) | 2 (0.1%) vs. 11 (0.8%) |
| 0.21 (0.02–1.81); P = 0.156 | 0.28 (0.03–2.71); P = 0.272 | 0.19 (0.04–0.84); P = 0.029 | |
| Urgent hospitalization for angina requiring coronary revascularization | 6 (1.0%) vs. 17 (2.9%) | 4 (1.1%) vs. 6 (1.7%) | 15 (1.1%) vs. 26 (1.9%) |
| 0.35 (0.14–0.88); P = 0.026 | 0.63 (0.18–2.24); P = 0.476 | 0.61 (0.32–1.16); P = 0.131 | |
| Secondary composite endpoint | 20 (3.3%) vs. 36 (6.1%) | 18 (4.9%) vs. 16 (4.5%) | 67 (4.9%) vs. 77 (5.5%) |
| 0.55 (0.32–0.95); P = 0.031 | 1.04 (0.53–2.03); P = 0.919 | 0.92 (0.66–1.28); P = 0.629 | |
| All-cause death | 6 (1.0%) vs. 6 (1.0%) | 8 (2.2%) vs. 7 (2.0%) | 26 (1.9%) vs. 31 (2.2%) |
| 1.03 (0.33–3.19); P = 0.962 | 1.03 (0.37–2.84); P = 0.957 | 0.90 (0.53–1.51); P = 0.684 | |
| All coronary revascularizations | 33 (5.5%) vs. 51 (8.7%) | 25 (6.9%) vs. 18 (5.1%) | 72 (5.3%) vs. 94 (6.7%) |
| 0.63 (0.40–0.97); P = 0.037 | 1.41 (0.76–2.61); P = 0.275 | 0.81 (0.59–1.10); P = 0.172 |
The primary composite endpoint included CV death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization. The secondary composite endpoint included CV death, resuscitated cardiac arrest, MI, and stroke. Only the initial event was counted in the analyses of time to first event for the primary composite endpoint and for the secondary composite endpoint.
Covariates included in the stepwise multivariable Cox regression models are: age; sex; BMI; smoking status; history of diabetes; history of hypertension; history of dyslipidaemia; prior MI; prior coronary revascularization (prior PCI or prior CABG); prior heart failure. All models also included TTI, group and the interaction between group and TTI.
CI, confidence interval; CV, cardiovascular; MI, myocardial infarction; HR, hazard ratio; PCI, percutaneous coronary intervention; TTI, time-to-treatment initiation.