Anti-inflammatory Effects of Colchicine in PCI

Peri-procedural inflammation is associated with increased rates of post-procedural myocardial
infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with
increased risk of later MI and death. Statins suppress both inflammatory markers and MI rates
during and after PCI, but ≥ 40% of PCI patients go statin-untreated, due in part to side
effects such as myalgia. Moreover, because their mechanism of action relies on
post-translational effects, statins must be given ≥ 12 to 24 hours prior to PCI, a time frame
that is not always feasible. The investigators propose a novel alternative approach to reduce
inflammation during PCI employing colchicine, an anti-inflammatory medication used frequently
in gout and pericarditis. Colchicine may be particularly applicable to the PCI setting due to
its rapid onset of action and excellent side-effect profile at low doses, as well as its
known mechanisms of action. However, data on colchicine use in patients with coronary disease
is extremely limited, and no studies to date have evaluated the use of colchicine in patients
undergoing PCI. The investigators aim to characterize a potential mechanism of benefit in
patients undergoing PCI by evaluating the effects of colchicine on soluble and leukocyte
surface markers after PCI. The investigators also aim to determine the effects of colchicine
on peri-procedural myonecrosis and MI. Accordingly, the investigators propose a prospective
randomized study to characterize the effect of colchicine on inflammation and peri-procedural
myocnecrosis. Patients referred for possible PCI will be randomized in a double-blinded
fashion to placebo or colchicine (1.2mg 1 to 2 hours before PCI, followed by 0.6mg 1 hour
later). The primary endpoint will be post-procedural interleukin-6 level. Secondary endpoints
will include other relevant soluble and leukocyte-associated inflammatory markers. Sample
size needed is 200 patients undergoing PCI. To adjust for a floor effect, 280 patients
undergoing PCI will be needed. 400 patients will likely be needed to be enrolled to reach 280
PCIs (the remaining will have undergone a diagnostic only procedure).