Table 1.
Baseline characteristics according to treatment allocation
| Characteristics | All patients | Colchicine group | Placebo group |
|---|---|---|---|
| (N = 4661) | (N = 2322) | (N = 2339) | |
| Age (years), mean ± SD | 60.5 ± 10.6 | 60.6 ± 10.6 | 60.5 ± 10.6 |
| Male sex, no. (%) | 3774 (81.0%) | 1861 (80.1%) | 1913 (81.8%) |
| BMI (kg/m2), mean ± SD | 28.3 ± 4.7 | 28.2 ± 4.8 | 28.4 ± 4.7 |
| Current smoking, no./total no. (%) | 1382/4659 (29.7) | 694/2322 (29.9%) | 688/2337 (29.4%) |
| History of hypertension, no. (%) | 2377 (51.0) | 1160 (50.0) | 1217 (52.0) |
| History of diabetes, no. (%) | 942 (20.2) | 451 (19.4) | 491 (21.0) |
| Prior MI, no. (%) | 751 (16.1) | 360 (15.5) | 391 (16.7) |
| Prior PCI, no. (%) | 783 (16.8) | 382 (16.5) | 401 (17.1) |
| Prior CABG, no. (%) | 146 (3.1) | 66 (2.8) | 80 (3.4) |
| Prior HF, no. (%) | 90 (1.9) | 48 (2.1) | 42 (1.8) |
| Prior stroke or TIA, no. (%) | 119 (2.6) | 53 (2.3) | 66 (2.8) |
| PCI associated with the index event, no. (%) | 4336 (93.0) | 2154 (92.8) | 2182 (93.3) |
| Medication use, no. (%): | |||
| Aspirin | 4605 (98.8) | 2291 (98.7) | 2314 (98.9) |
| Other anti-platelet agent | 4567 (98.0) | 2267 (97.6) | 2300 (98.3) |
| Statin | 4615 (99.0) | 2297 (98.9) | 2318 (99.1) |
| Beta-blocker | 4143 (88.9) | 2077 (89.4) | 2066 (88.3) |
| TTI 0–3 days, no. (%) | 1193 (25.6) | 604 (26.0) | 589 (25.2) |
| TTI 4–7 days, no. (%) | 720 (15.4) | 364 (15.7) | 356 (15.2) |
| TTT ≥8 days, no. (%) | 2748 (59.0) | 1354 (58.3) | 1394 (59.6) |
| Time from index MI to randomization (days), mean ± SD | 13.5 ± 10.1 | 13.5 ± 10.1 | 13.5 ± 10.0 |
| Time from Index MI to PCI (days), mean ± SD | 1.4 ± 2.9 | 1.4 ± 2.9 | 1.4 ± 2.9 |
| Time from PCI to randomization (days), mean ± SD | 11.9 ± 9.9 | 11.9 ± 9.9 | 11.9 ± 9.9 |
Data were missing on the following characteristics: age (assessed according to date of birth; see below) for 431 patients (213 in the colchicine group and 218 in the placebo group) and body-mass index (the weight in kilograms divided by the square of the height in meters) for 5 (1 and 4 patients, respectively).
Date of birth was not required field because it was considered in some countries to be sensitive data that could allow for the identification of patients.
For statistical reporting, missing information regarding the day of birth was replaced by 15, and missing information regarding the month and day of birth was replaced by 1 July.
CABG, coronary artery bypass graft surgery; HF, heart failure; PCI, percutaneous coronary intervention; TIA, transient ischaemic attack.