Coronary disease & ACSRandomised controlled trial
Effect of colchicine on progression of known coronary atherosclerosis in patients with stable coronary artery disease: EKSTROM randomized placebo controlled trial
- prospective, randomized, double-blinded, placebo-controlled trial
Authors' conclusion
In the EKSTROM trial, low-dose colchicine did not significantly reduce low attenuation plaque volume in patients with stable coronary artery disease over 12 months, but did achieve a significant reduction in total plaque burden (percent atheroma volume) and dense calcified plaque compared to placebo. Colchicine was well tolerated, with no major safety concerns. In this stable well-treated CAD population, LAP was rare and not significantly reduced; however, it slowed overall plaque progression, supporting further investigation of its role in secondary prevention of coronary artery disease.
Study context
- Population
- Patients with stable coronary artery disease (CAD) with proven coronary artery disease by coronary angiography, CT coronary angiography, or a Coronary Artery Calcium Score >40072 participants completed the study
- Participants
- 84 patients
- Comparison
- colchicine vs placebo for 12 months
- Primary endpoint
- Rate of change in low attenuation plaque (LAP) volume by serial coronary computed tomography angiography (CCTA)
- Follow-up
- 12 months
Primary result
As reported in the abstract
colchicine
0.1
median · IQR −02–0.2
placebo
0.0
median · IQR −0.2–0.3
P = 0.342
Secondary outcomes
Median
| Outcome | colchicine | placebo | P value |
|---|---|---|---|
| Total plaque percent atheroma volume (PAV%) (secondary endpoint) · 12-month scan · unadjusted; lower in the colchicine group | 0.3 (IQR −0.1–1.3) | 1.4 (IQR 0.4–2.6) | P = 0.008 |
| Total plaque percent atheroma volume (PAV%) (secondary endpoint) · 12-month scan | P = 0.015 |
- Total plaque percent atheroma volume (PAV%) (secondary endpoint): multivariate models; colchicine associated with lower PAV at 1 year
Non-calcified and fibro-fatty plaque
- Trends toward regression in non-calcified and fibro-fatty plaque
Inflammatory markers
- Reduced with colchicine, but did not achieve statistical significance
Original publication
Summarised from the published abstract; every number is checked against it