Table 1

Characteristics of studies included in the systematic review.

StudyO'Keefe (1992)11Deftereos (2013)12CISR (2019)13COLCOT (2019)14LoDoCo-MI (2019)15Colchicine-CI (2020)16COPS (2020)17
DesignDouble blinded RCTDouble blinded RCTUnblinded RCTDouble blinded RCTDouble blinded RCTDouble blinded RCTDouble blinded RCT
PopulationPatients who had undergone successful coronary angioplasty. Premenopausal women excluded.Patients undergoing PCI with a BMS who are of 40–80 years of age, with DM and a contraindication to DES.Patients above the age of 40 who underwent PCI with BMS or DES for treatment of stable IHD or ACS. Women of childbearing potential excluded.
A: BMS +Colchicine
B: BMS only
Patients who had an MI within 30 days before enrolment and had completed any planned percutaneous revascularisation procedures. Excluded if had stroke within previous 3 months, type two index MI, recent or planned CABG.Patients who sustained a type one acute MI within the prior 7 days. Pregnant, lactating or women of childbearing age not on contraception excluded.Patients aged above 18 years with suspected ischaemic heart disease or ACS referred for clinically indicated coronary angiography and PCI.Patients presented with ACS and had evidence of CAD on coronary angiography, managed with either PCI or medical therapy. Excluded if needing surgical revascularisation.
No (T/C)197 (130/67)196 (100/96)90 (30/30/30)4745 (2366/2379)237 (119/118)400 (206/194)795 (396/399)
Mean age, yrs ±SD60.0
T: 59
C: 62
T: 63.7±6.9
C: 63.5±7.2
A: 57.5±6.7
B: 62.6±3
C: 61.8±7
T: 60.6±10.7
C: 60.5±10.6
61 ±13.0
T: 61±13.6
C: 61±12.5
T: 65.9±9.9
C: 66.6±10.2
T: 59.7±10.2
Males, n (%)169 (85.8)128 (65.3)75 (83.3)
A: 228 (93.3)
B: 21 (70.0)
C: 26 (86.7)
3836 (80.8)182 (76.8)374 (93.5)632 (79.5)
HTN, n (%)N/A95 (48.5)42 (47.8)
A: 18 (60.0)
B: 11 (36.7)
14 (46.7)
2421 (51.0)112 (47.3)367 (91.8)400 (50.3)
DM, n (%)24 (8.08)196 (100)39 (43.3)
A: 15 (50.0)
B: 10 (33.3)
C: 14 (46.7)
959 (20.2)52 (21.9)231 (57.8)151 (20.0)
Smoking history, n (%)N/A74 (37.8)32 (35.6)
A: 9 (30.0)
B: 12 (40.0)
C: 10 (33.3)
1416 (29.8)143 (60.3)282 (70.5)277 (34.8)
PCI, n (%)100 (angioplasty)196 (100)90 (100)
A: 30 (100)
B: 30 (100)
C: 30 (100)
4408 (92.9)237 (100)400 (100)691 (86.9)
Antiplatelet, n (%)N/AN/A89 (98.9)
A: 30 (100)
B: 29 (97.0)
C: 30 (100)
4686 (98.8)237 (100)362 (90.5)784 (98.6)
Statin, n (%)N/AN/A90 (100)
A: 30 (100)
B: 28 (93.3)
C: 30 (100)
4696 (99.0)233 (98.3)362 (90.5)786 (98.9)
Colchicine dose0.6 mg BD0.5 mg BD0.5 mg BD0.5 mg OD0.5 mg ODOne off 1.2 mg, followed by 0.6 mg0.5 mg BD for first month, followed by 0.5 mg OD for 11 months
Time of colchicine initiationBefore angioplasty or within 24 hours after angioplasty.From day of index PCI (within 24 hours).After BMS implantation.After assignment to group.Within 7 days post-MI.1.2 mg given 1 to 2 hours before coronary angiography, followed by 0.6 mg immediately before PCI.After assignment to group.
Median follow-up5.5 months6 months6 months22.6 months30 days30 days12 months
Primary outcomeAngiographic ISR measured by electronic callipers.Angiographic ISR and IVUS-ISR (defined as in-stent minimum lumen area of <4 mmˆtwo at follow-up).Clinical ISR at 6 months, defined as recurrence of angina pectoris or evidence of MI (>50% restenosis).Composite of death from CV causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalisation for angina leading to coronary revascularisation in a time-to-event analysis.Proportion of patients with a residual hs-CRP level ≥2 mg/L at 30 days.PCI-related myocardial injury, according to Troponin I measurements.Composite of death from any cause, ACS, ischaemia-driven urgent revascularisation and non-cardioembolic ischaemic stroke.
Secondary outcomeAdverse drug effects in placebo or colchicine.Angiographic and IVUS parameters of lumen loss and in-stent neointimal hyperplasia, including late lumen loss (angiography), lumen area loss, percentage of neointima volume, and normalised neointima volume (IVUS).Target-vessel revascularisation and stent thrombosis within 6 months.Secondary end points consisted of the components of the primary efficacy end point; a composite of death from CV causes, resuscitated cardiac arrest, MI or stroke; and total mortality in time-to-event analyses. Coronary revascularisation, hospitalisation for heart failure, atrial fibrillation, and deep vein thrombosis or pulmonary embolus were prespecified as exploratory end points in the protocol.Actual levels of hs-CRP at 30 days and the relative and absolute change in hs-CRP levels from baseline to 30 days. Others: proportion of recruited patients completing the study, adverse events, participant-reported compliance with study medications, and death and major CV events at 30 days.Occurrence of 30-day MACE, a composite of the earliest occurrence of death from any cause, nonfatal MI, or target vessel revascularisation, PCI-related MI. Nonfatal MI defined as PCI-related or type 1 MI.Components of the primary endpoint, as well as hospitalisation for chest pain. Post hoc analysis performed after unblinding of trial using cardiovascular death as an outcome measure.
  • ACS, acute coronary syndrome; BD, two times per day; BMS, bare metal stent; C, control; CABG, coronary artery bypass graft surgery; CAD, coronary artery disease; CRP, C reactive protein; CV, cardiovascular; DES, drug-eluting stent; DM, diabetes mellitus; hs-CRP, high-sentivity C reactive protein; HTN, hypertension; ISR, in-stent restenosis; IVUS, intravascular ultrasound; MI, myocardial infarction; N/A, not available; OD, once daily; PCI, percutaneous coronary intervention; RCT, randomised controlled trial; T, treatment; TvC, treatment versus control; UA, unstable angina.