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On April 1, 2025, we reported on late-breaking data from the randomized, double-blind, placebo-controlled EKSTROM trial presented at the American College of Cardiology 74th Annual Scientific Session and Expo.
The study
The double-blind, placebo-controlled study enrolled 84 participants, with 72 completing the trial. Patients were randomized to receive either colchicine (0.5 mg daily) or a placebo as an add-on therapy to standard care. Coronary computed tomography angiography was performed at baseline and 12 months to assess plaque progression.
The primary endpoint was change in low-attenuation plaque volume (LAP), a quantification of non-calcified, lipid-rich plaque, compared to placebo as measured by CCTA. Secondary endpoints included change in total plaque volume, and change in total non-calcified plaque, fibro-fatty, fibrous and dense calcified plaques.
The findings
Results showed a significant reduction in total plaque volume with colchicine vs placebo over 12 months (change in percent atheroma volume [PAV] was -1.1% between groups; P =.015). Additionally, colchicine treatment significantly reduced dense calcified plaque volume (-0.9% PAV; P =.009).
At 1 year, there was barely any change in either group in the primary outcome of low attenuation plaque (P = .344), but the key secondary outcome of total plaque volume was increased less in the colchicine group than in the placebo group (rise in percent atheroma volume, 0.3% vs. 1.4%; P = .015).
Authors' comments
"These findings are concordant with prior research that demonstrates that low-dose colchicine, 0.5 mg, improved coronary plaque stability in patients with acute coronary syndrome. Taken together, these results may point to the underlying mechanism explaining how low-dose colchicine, 0.5 mg, can prevent heart attack and stroke in high-risk patients with established cardiovascular disease."
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