Table 4.
Main studies published on colchicine and its CV implications
| TRIAL (year) | LoDoCo [43] (2013) |
COLIN [65] (2017) |
LoDoCo2[45] (2020) |
COLCHICINE-PCI [68] (2020) | COPS [64] (2020) |
COLCOT [46] (2020) |
|---|---|---|---|---|---|---|
| Patients enrolled |
535 (473 male) |
44 (35 male) |
5522 (4676 male) |
400 (374 male) |
795 (632 male) |
4745 (3836 male) |
| Median follow-up | 3 years | 1 month | 28.6 months | 1 month | 12 month | 22.6 months |
| Setting | CCS | ACS | CCS | ACS/CCS | ACS | ACS |
| Study design and aims | Randomized, prospective, observer-blinded endpoint trial to assess efficacy of continuous low-dose of colchicine treatment in patients with stable CAD in reducing CV events | Randomized, prospective, open-label, controlled trial to assess effect of colchicine plus OMT or OMT alone in STEMI patients | Randomized, controlled, double-blind trial to further assess the effect of colchicine in patients with chronic coronary disease | Randomized, double-blinded, placebo-controlled trial to determine the effects of acute preprocedural oral administration of 1.8 mg of colchicine on PCI-related myocardial injury | Randomized, double-blind, placebo-controlled trial to assess the effect of oral colchicine on CV events in patients presenting with ACS | Randomized, double-blind, placebo-controlled, investigator-initiated trial to assess the effects of colchicine on CV outcomes and its safety profile in patients with recent MI (within 30 days) |
|
Colchicine dosing regimen |
0.5 mg QD | 1 mg QD for 1 month | 0.5 mg QD | Acute preprocedural oral use of 1.8 mg of colchicine | 0.5 mg BID for first month followed by 0.5 mg QD for 11 months | 0.5 mg QD |
| Primary endpoint | Composite of ACS, fatal or nonfatal out-of-hospital cardiac arrest, or noncar- dioembolic ischemic stroke | CRP peak during the index hospitalization | Composite of cardiovascular death, spontaneous (non- procedural) MI, ischemic stroke, or ischemia-driven coronary revascularization | PCI-related myocardial injury | Composite of death from any cause, ACS (STEMI/NSTEMI/UA), ischemia-driven urgent revascularization and non-cardioembolic ischemic stroke | Composite of death from CV causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization in a time-to-event analysis |
| Secondary endpoints | Components of the primary outcome and the components of ACS unrelated to stent disease | Troponin peak, tolerance of colchicine, hospitalization duration, MACE at 1-month follow-up; cardiac remodeling | Composite of cardiovascular death, spontaneous MI, or ischemic stroke | MACEs at 30 days; composite of the earliest occurrence of death from any cause, nonfatal MI, or target vessel revascularization; PCI-related MI; change in plasma inflammatory markers concentration between baseline and post-PCI | Components of the primary endpoint and hospitalization for chest pain | Components of the primary efficacy end point; composite of death from CV causes, resuscitated cardiac arrest, MI, or stroke; total mortality in time to-event analyses |
| Primary endpoint reached |
YES 5.3%—colchicine 16.0%—placebo HR 0.33 (95% CI 0.18–0.59) P < 0.0001 |
NO 29.03 mg/L – colchicine 21.86 mg/L – control group P = 0.36 |
YES 6.8%—colchicine 9.6%—placebo HR 0.69 (95% CI 0.57–0.83) P < 0.001 |
NO 57.3%—colchicine 64.2%—placebo P = 0.19 |
NO 24 events – colchicine (24/396) 38 events – placebo (38/399) P = 0.09 |
YES 5.5%—colchicine 7.1%—placebo HR 0.77 (95% CI 0.61–0.96) P = 0.02 |
ACS acute coronary syndromes; CAD coronary artery disease; CI confidence interval; CRP C-reactive protein; CV cardiovascular; HR hazard ratio; MI myocardial infarction; NS non-significant; OMT optimized medical therapy; RR relative risk; UA unstable angina