A Comparative Trial of Early Colchicine Initiation Following Percutaneous Coronary Intervention to Prevent Peri-Stent Inflammation and Restenosis

Abstract

Background: Peri-stent inflammation contributes to neointimal proliferation and in-stent restenosis after percutaneous coronary intervention despite advances in drug-eluting stent technology and standard pharmacological therapy. Colchicine has established anti-inflammatory effects, but its early use after PCI for reducing peri-stent inflammation remains insufficiently defined. Objective: To evaluate whether early colchicine initiation after PCI reduces inflammatory biomarker levels and the incidence of in-stent restenosis compared with standard post-PCI therapy alone. Methods: This parallel-group randomized controlled trial enrolled 72 patients who underwent successful PCI with drug-eluting stent implantation. Participants were randomized equally to colchicine plus standard therapy or standard therapy alone. Colchicine was administered for three months. The final complete-case analysis included 67 participants. Outcomes included hs-CRP, IL-6, angiographic in-stent restenosis, angina severity, ESR, and major adverse cardiovascular events at three months. Results: At three months, hs-CRP was lower in the colchicine group than in controls (2.1 ± 0.8 vs 3.8 ± 1.1 mg/L; p<0.001), as was IL-6 (4.6 ± 1.4 vs 7.2 ± 1.9 pg/mL; p<0.001). In-stent restenosis occurred in 9.1% versus 26.5% of participants, respectively (p=0.037). Angina severity, ESR, and major adverse cardiovascular events also favored colchicine therapy. Conclusion: Early colchicine initiation after PCI was associated with reduced inflammatory activity and lower observed restenosis at three months, although larger multicenter trials with longer follow-up are needed.