Inflammation is a key driver of atherosclerotic coronary artery disease (CAD), and elevated C-reactive protein (CRP) identifies patients at heightened residual inflammatory risk despite contemporary lipid-lowering and antithrombotic therapy. ,, Randomized trials, including COLCOT and LoDoCo2, have demonstrated cardiovascular benefit with low-dose colchicine in patients with chronic or recent CAD, , but data evaluating its effectiveness in real-world populations selected for elevated inflammatory burden remain limited. We therefore examined clinical outcomes associated with colchicine therapy among patients with CAD and elevated CRP using a large multicenter electronic health record network.
This retrospective cohort study was conducted using the TriNetX Research Network, which includes de-identified data from approximately 160 million patients across multiple healthcare organizations in the United States. Diagnoses were identified using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. Adults aged ≥18 years with documented CAD and at least one CRP measurement between 2 and 1000 mg/L were eligible. Patients who received colchicine within 7 days of the qualifying CRP measurement formed the exposure cohort. Patients with no colchicine exposure served as controls. Individuals with gout, psoriasis, acute pericarditis, or severe renal impairment (estimated glomerular filtration rate <30 ml/min/1.73 m²) were excluded. To minimize confounding, 1:1 propensity score matching was performed using demographic variables, cardiovascular comorbidities, medication use, laboratory values, and procedures. Baseline characteristics after matching were well balanced between groups, with standardized mean differences <0.10 across all covariates ( Table 1 ). The primary outcome was all-cause mortality at 12 months. Secondary outcomes included stroke, myocardial infarction, acute heart failure, acute kidney injury, atrial fibrillation or flutter, respiratory failure requiring mechanical ventilation, and a composite 3-point major adverse cardiovascular event (MACE) defined as all-cause mortality, myocardial infarction, or stroke. Patients with a history of a given outcome before the index date were excluded from the corresponding outcome-specific analysis.
Table 1
Baseline characteristics of the study cohort before and after propensity score matching
| Before propensity score matching | After propensity score matching | |||||||
|---|---|---|---|---|---|---|---|---|
| Cohort 1 (n = 19,117) | Cohort 2 (n = 925,009) | p-value | SMD | Cohort 1 (n = 19,075) | Cohort 2 (n = 19,075) | p-value | SMD | |
| Demographics | ||||||||
| Current Age, mean, (SD) | 72.2 (13.3) | 73.6 (12.1) | <0.001 | 0.110 | 72.2 (13.3) | 72.1 (12.8) | 0.317 | 0.010 |
| Age at index, mean, (SD) | 67.8 (13.3) | 68.6 (12.4) | <0.001 | 0.064 | 67.8 (13.3) | 67.7 (13.1) | 0.410 | 0.008 |
| Female, n (%) | 6,680 (35.0%) | 408,257 (44.5%) | <0.001 | 0.095 | 6,680 (35.0%) | 6,701 (35.1%) | 0.822 | 0.002 |
| Male, n (%) | 12,597 (66.0%) | 508,851 (55.5%) | <0.001 | 0.195 | 12,395 (65.0%) | 12,374 (64.9%) | 0.822 | 0.002 |
| White, n (%) | 12,597 (66.0%) | 688,938 (75.1%) | <0.001 | 0.200 | 12,597 (66.0%) | 12,574 (65.9%) | 0.804 | 0.003 |
| Black or African American, n (%) | 2,863 (15.0%) | 408,257 (11.8%) | <0.001 | 0.095 | 2,863 (15.0%) | 2,915 (15.3%) | 0.458 | 0.008 |
| Asian, n (%) | 1,181 (6.2%) | 34,619 (3.8%) | <0.001 | 0.111 | 1,181 (6.2%) | 1,193 (6.3%) | 0.799 | 0.003 |
| American Indian or Alaska Native, n (%) | 58 (0.3%) | 4,332 (0.5%) | <0.001 | 0.027 | 58 (0.3%) | 66 (0.3%) | 0.472 | 0.007 |
| Unknown Race, n (%) | 1,782 (9.3%) | 55,912 (6.1%) | <0.001 | 0.122 | 1,781 (9.3%) | 1,739 (9.1%) | 0.457 | 0.008 |
| Native Hawaiian or Other Pacific Islander, n (%) | 148 (0.8%) | 4,105 (0.4%) | <0.001 | 0.042 | 148 (0.8%) | 160 (0.8%) | 0.492 | 0.007 |
| Unknown Ethnicity, n (%) | 3,407 (17.9%) | 158,446 (17.3%) | 0.035 | 0.015 | 3,406 (17.9%) | 3,389 (17.8%) | 0.820 | 0.002 |
| Not Hispanic or Latino, n (%) | 14,777 (77.5%) | 712,649 (77.7%) | 0.418 | 0.006 | 14,777 (77.5% | 14,803 (77.6%) | 0.750 | 0.003 |
| Other Race, n (%) | 448 (2.3%) | 21,247 (2.3%) | 0.774 | 0.002 | 447 (2.3%) | 428 (2.2%) | 0.516 | 0.007 |
| Comorbidities | ||||||||
| Heart failure | 8,381 (43.9%) | 260,607 (28.4%) | <0.001 | 0.327 | 8,379 (43.9%) | 8,503 (44.6%) | 0.201 | 0.013 |
| Essential (primary) hypertension | 15,050 (78.9%) | 693,851 (75.7%) | <0.001 | 0.077 | 15,050 (78.9%) | 15,150 (79.4%) | 0.207 | 0.013 |
| Other chronic obstructive pulmonary disease | 4,234 (22.2%) | 201,102 (21.9%) | 0.379 | 0.006 | 4,234 (22.2%) | 4,262 (22.3%) | 0.730 | 0.004 |
| Chronic kidney disease (CKD) | 5,458 (28.6%) | 191,032 (20.8%) | <0.001 | 0.181 | 5,457 (28.6%) | 5,523 (29.0%) | 0.455 | 0.008 |
| Fibrosis and cirrhosis of liver | 705 (3.7%) | 30,831 (3.4%) | 0.011 | 0.018 | 705 (3.7%) | 650 (3.4%) | 0.128 | 0.016 |
| Type 1 diabetes mellitus | 876 (4.6%) | 46,029 (5.0%) | 0.007 | 0.020 | 876 (4.6%) | 848 (4.4%) | 0.490 | 0.007 |
| Atrial fibrillation and flutter | 6,701 (35.1%) | 215,981 (23.6%) | <0.001 | 0.256 | 6,700 (35.1%) | 6,739 (35.3%) | 0.676 | 0.004 |
| Atrioventricular and left bundle-branch block | 3,208 (16.8%) | 102,475 (11.2%) | <0.001 | 0.163 | 3,208 (16.8%) | 3,088 (16.2%) | 0.098 | 0.017 |
| Type 2 diabetes mellitus | 8,160 (42.8%) | 359,976 (39.3%) | <0.001 | 0.072 | 8,160 (42.8%) | 8,107 (42.5%) | 0.583 | 0.006 |
| Overweight and obesity | 6,853 (35.9%) | 292,664 (31.9%) | <0.001 | 0.085 | 6,853 (35.9%) | 6,964 (36.5%) | 0.237 | 0.012 |
| Sleep apnea | 4,915 (25.8%) | 204,099 (22.3%) | <0.001 | 0.082 | 4,915 (25.8%) | 4,947 (25.9%) | 0.708 | 0.004 |
| Cerebral infarction | 2,229 (11.7%) | 100,199 (10.9%) | 0.001 | 0.024 | 2,229 (11.7%) | 2,161 (11.3%) | 0.275 | 0.011 |
| Other immunodeficiencies | 755 (4.0%) | 26,566 (2.9%) | <0.001 | 0.058 | 755 (4.0%) | 771 (4.0%) | 0.676 | 0.004 |
| Tobacco use | 1,421 (7.4%) | 71,932 (7.8%) | 0.045 | 0.015 | 1,421 (7.4%) | 1,386 (7.3%) | 0.492 | 0.007 |
| Hyperlipidemia, unspecified | 12,419 (65.1%) | 558,774 (60.9%) | <0.001 | 0.086 | 12,419 (65.1%) | 12,322 (64.6%) | 0.298 | 0.011 |
| Procedures | ||||||||
| Hemodialysis procedures | 71 (0.4%) | 4,466 (0.5%) | 0.024 | 0.018 | 71 (0.4%) | 85 (0.4%) | 0.261 | 0.012 |
| Heart and great vessels/Dilation/Coronary artery, One artery | 1,844 (9.7%) | 35,621 (3.9%) | <0.001 | 0.232 | 1,842 (9.7%) | 1,735 (9.1%) | 0.060 | 0.019 |
| Heart and great vessels/Dilation/Coronary artery, Two arteries | 755 (4.0%) | 18,097 (2.0%) | <0.001 | 0.117 | 753 (3.9%) | 700 (3.7%) | 0.156 | 0.015 |
| Heart and great vessels/Dilation/Coronary artery, Three arteries | 537 (2.8%) | 14,620 (1.6%) | <0.001 | 0.083 | 537 (2.8%) | 538 (2.8%) | 0.975 | <0.001 |
| Heart and great vessels/Dilation/Coronary artery, Four or more arteries | 487 (2.6%) | 14,019 (1.5%) | <0.001 | 0.072 | 487 (2.6%) | 481 (2.5%) | 0.845 | 0.002 |
| Heart and great vessels/Bypass/Coronary artery, One artery | 939 (4.9%) | 17,239 1.9%) | <0.001 | 0.168 | 938 (4.9%) | 877 (4.6%) | 0.142 | 0.015 |
| Heart and great vessels/Bypass/Coronary artery, Two arteries | 415 (2.2%) | 7,692 (0.8%) | <0.001 | 0.110 | 415 (2.2%) | 398 (2.1%) | 0.547 | 0.006 |
| Heart and great vessels/Bypass/Coronary artery, Three arteries | 200 (1.0%) | 4,449 (0.5%) | <0.001 | 0.065 | 200 (1.0%) | 199 (1.0%) | 0.960 | 0.001 |
| Heart and great vessels/Bypass/Coronary artery, Four or more arteries | 83 (0.4%) | 1,728 (0.2%) | <0.001 | 0.044 | 83 (0.4%) | 70 (0.4%) | 0.292 | 0.011 |
| Medication | ||||||||
| Ace inhibitors | 8,391 (44.0%) | 340,536 (37.1%) | <0.001 | 0.140 | 8,391 (44.0%) | 8,492 (44.5%) | 0.298 | 0.011 |
| Angiotensin II receptor blockers (ARBS), Plain | 6,954 (36.5%) | 255,004 (27.8%) | <0.001 | 0.186 | 6,953 (36.5%) | 6,897 (36.2%) | 0.551 | 0.006 |
| Beta blocking agents | 14,919 (78.2%) | 590,816 (64.4%) | <0.001 | 0.308 | 14,917 (78.2%) | 14,984 (78.6%) | 0.405 | 0.009 |
| Clopidogrel | 5,760 (30.2%) | 193,348 (21.1%) | <0.001 | 0.210 | 5,758 (30.2%) | 5,760 (30.2%) | 0.982 | <0.001 |
| Ticagrelor | 1,402 (7.3%) | 25,997 (2.8%) | <0.001 | 0.206 | 1,400 (7.3%) | 1,397 (7.3%) | 0.953 | 0.001 |
| Prasugrel | 539 (2.8%) | 11,775 (1.3%) | <0.001 | 0.109 | 539 (2.8%) | 501 (2.6%) | 0.232 | 0.012 |
| Laboratory | ||||||||
| Platelets (#/volume) in blood | 249.5 ± 106.5 | 242.6 ± 97.3 | <0.001 | 0.068 | 249.5 ± 106.5 | 241.5 ± 100.3 | <0.001 | 0.077 |
| 0–150, 10 × 3/ul | 7,592 (39.8%) | 291,894 (31.8% | <0.001 | 0.167 | 7,591 (39.8%) | 7,547 (39.6%) | 0.645 | 0.005 |
| 150–450, 10 × 3/ul | 18,062 (94.7%) | 825,074 (90.0%) | <0.001 | 0.178 | 18,060 (94.7%) | 18,093 (94.9%) | 0.448 | 0.008 |
| Hematocrit (Volume fraction) of blood | 36.4 ± 7.6 | 37.7 ± 7.3 | <0.001 | 0.179 | 36.4 ± 7.6 | 37.0 ± 7.6 | <0.001 | 0.081 |
| 0–40% | 15,989 (83.8%) | 701,124 (76.4%) | <0.001 | 0.185 | 15,987 (83.8%) | 15,944 (83.6%) | 0.551 | 0.006 |
| 40–54% | 14,817 (77.7%) | 679,589 (74.1%) | <0.001 | 0.083 | 14,815 (77.7%) | 14,798 (77.6%) | 0.835 | 0.002 |
| 54–100% | 485 (2.5%) | 16,974 (1.9%) | <0.001 | 0.047 | 485 (2.5%) | 477 (2.5%) | 0.794 | 0.003 |
| Leukocytes (#/volume) in blood | 74.5 ± 537.8 | 47.9 ± 416.9 | <0.001 | 0.055 | 74.5 ± 537.9 | 62.5 ± 482.3 | 0.035 | 0.023 |
| 0–4.50, 10 × 3/ul | 4,543 (23.8%) | 209,547 (22.8%) | 0.002 | 0.023 | 4,543 (23.8%) | 4,608 (24.2%) | 0.436 | 0.008 |
| 4.50–11, 10 × 3/ul | 15,237 (79.9%) | 721,472 (78.7%) | <0.001 | 0.030 | 15,235 (79.9%) | 15,280 (80.1%) | 0.565 | 0.006 |
| 11–100, 10 × 3/ul | 10,791 (56.6%) | 420,785 (45.9%) | <0.001 | 0.215 | 10,789 (56.6%) | 10,782 (56.5%) | 0.942 | 0.001 |
| Left ventricular ejection fraction (LVEF) (%) | 54.3 ± 14.3 | 56.5 ± 13.5 | <0.001 | 0.158 | 54.3 ± 14.3 | 54.8 ± 14.4 | 0.126 | 0.036 |
| 1–20% | 164 (0.9%) | 2,947 (0.3%) | <0.001 | 0.070 | 164 (0.9%) | 153 (0.8%) | 0.535 | 0.006 |
| 20–24% | 181 (0.9%) | 3,462 (0.4%) | <0.001 | 0.070 | 181 (0.9%) | 167 (0.9%) | 0.451 | 0.008 |
| 25–29% | 221 (1.2%) | 4,385 (0.5%) | <0.001 | 0.076 | 221 (1.2%) | 221 (1.2%) | 1 | <0.001 |
| 30–34% | 252 (1.3%) | 5,694 (0.6%) | <0.001 | 0.071 | 252 (1.3%) | 246 (1.3%) | 0.787 | 0.003 |
| 35–39% | 263 (1.4%) | 7,238 (0.8%) | <0.001 | 0.057 | 263 (1.4%) | 267 (1.4%) | 0.861 | 0.002 |
| 40–44% | 358 (1.9%) | 9,336 (1.0%) | <0.001 | 0.072 | 358 (1.9%) | 362 (1.9%) | 0.880 | 0.002 |
| 45–54% | 993 (5.2%) | 27,555 (3.0%) | <0.001 | 0.111 | 993 (5.2%) | 1,054 (5.5%) | 0.166 | 0.014 |
| 55–59% | 1,164 (6.1%) | 34,318 (3.7%) | <0.001 | 0.109 | 1,164 (6.1%) | 1,156 (6.1%) | 0.864 | 0.002 |
| 60–100% | 2,340 (12.3%) | 79,981 (8.7%) | <0.001 | 0.116 | 2,340 (12.3%) | 2,387 (12.5%) | 0.465 | 0.007 |
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