Coronary artery disease (CAD) is the leading cause of death in Belgium (7,312 deaths or 6.7% of all deaths in 2017). CAD clinically presents as an acute coronary syndrome or myocardial infarction (ACS), or chronic coronary syndrome or stable angina (CCS). Both ACS and CCS are in the majority of the cases treated with percutaneous coronary interventions (PCI) on top of optimal medical therapy, with approximatively 31,000 PCI procedures being performed per year in Belgium.
Even with the best standards of care, the rate of recurrent cardiovascular events after a PCI remains high, up to 8.58% annually (major adverse cardiovascular events or MACE, the composite of death, ACS, stroke, coronary revascularization). This comes at a high cost, both in terms of loss of year of life and from health economics perspectives. There is therefore an unmet need to reduce recurrent cardiovascular events in this high-risk population.
Inflammation is widely believed to play a central role in this pathogenesis of CAD, but no anti-inflammatory therapy has thus far been approved for clinical use in this indication.
Colchicine is an oral anti-inflammatory medication widely used since ancient times for the treatment of gout and other inflammatory diseases. It is very safe and is well tolerated, with few side-effects. Recent studies have shown promising results for colchicine in the prevention of recurrent cardiovascular problems in patients with CAD, but uncertainties remain. Further studies are therefore urgently needed.
The COL BE PCI trial is a randomized, double blind, placebo-controlled multicenter trial in Belgium comparing low dose of oral colchicine 0.5 mg daily versus placebo in 2770 patients with CAD treated with PCI. It aims to show a 25% reduction in new heart problems after PCI.
If our hypothesis is to be confirmed, given that colchicine is off-patent and very cheap (53.2€ per year per patient), this trial could demonstrate a net and direct cost-benefit of ±4 millions € per year for Belgium, and directly improve the health and quality of life of many heart patients.
| Title |
COLchicine in BElgium in patients with coronary artery disease after Percutaneous Coronary Intervention (COL BE PCI) |
|
Participants (P) |
Patients ≥45 years with coronary artery disease (CAD), treated with percutaneous coronary intervention (PCI), with at least one additional cardiovascular risk factor as identified by theSMART (Second Manifestations of Arterial Disease) risk score: age ≥60-year, diabetes mellitus, smoking, hypertension, high cholesterol, hsCRP ≥2 mg/dl and CCS, kidney insufficiency, history of vascular disease (CAD, stroke, PAD, AAA), able to be enrolled/randomized between 2 hour and 5 days post PCI. |
|
Intervention (I) |
Low dose colchicine 0.5 mg daily, currently available in Belgium. Therapy will be started in-hospital and continued daily for the duration of the trial (±3,7 years). |
|
Control (C) |
Matching placebo. |
|
Outcome (O) |
Time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or ischemia-driven coronary revascularization. |
|
Trial Design |
Randomized, double blind, placebo-controlled, pragmatic and comparative-effectiveness trial, with patient centred outcomes. After signing the informed-consent form, eligible patients will be randomly assigned in a 1:1 ratio to receive 0.5 mg of colchicine once daily or matching placebo. |
|
Sample Size |
2770 patients |
|
Trial duration |
47 months |
|
Budget |
5.37 MIO |
| Sponsor | AZ St Jan and UZ Gent (co-sponsor) |
| Chief Investigator | Dr Ian Buysschaert |
| External partners | HIRUZ, Novitan, Alea |
| Number of participating sites | 18 sites
|
