Randomized comparison between bare-metal stent plus colchicine versus drug-eluting stent alone in prevention of clinical adverse events after percutaneous coronary intervention

The use of colchicine is associated with a significant reduction of cardiac adverse events in patients with coronary artery disease. Past small randomized trials with oral immunosuppressive or anti-inflammatory therapies have demonstrated a reduction of adverse clinical events after bare metal stent implantation. The potential role of adjunctive colchicine after bare-metal stent implantation, compared with drug-eluting stent alone, is unknown. The primary end point of the study will be to compare cost-effectiveness at 1 year of follow-up of coronary intervention with bare-metal stent implantation plus 1 mg of colchicine during 3 months versus percutaneous coronary intervention with drug-eluting stent implantation alone. ClinicalTrials.gov identifier: NCT04382443</ext-link. Colchicine is an anti-inflammatory drug used to reduce the chance of heart attacks in patients with heart disease. The use of stents - small tubes inserted into blood vessels to keep them open - in this group of people is well known, and several small clinical trials have been carried out to investigate this. Our trial aims to assess if there is a role for using colchicine after inserting a stent, compared with using stents that release drugs themselves (drug-eluting stents), to reduce side effects and complications of cardiac procedures. Our primary objective will be to demonstrate that this drug, combined with the old metallic stent designs, will prevent future complications in comparison with the latest generation of drug-eluting stents.