A clinical investigator from the VA New York Harbor Healthcare System in New York, NY, recently presented results of the COLCHICINE-PCI trial to the American Heart Association 2019 Scientific Sessions. The investigators found that colchicine given orally prior to percutaneous coronary intervention (PCI) in all-comers population doesn’t reduce procedure-related myocardial injury but does appear to attenuate the inflammatory response reports the Cardiovascular Research Foundation’s TCTMD.
Good News then Bad News
Unfortunately this trial’s disappointing results came a day after the presentation of COLCOT, which evidenced that colchicine, an anti-inflammatory agent already indicated for use in gout and pericarditis, lowered the risk of ischemic cardiovascular events after recent STEMI study.
The COLCHICINE-PCI Study
COLCHICINE-PCI randomized 714 patients to 1.2 mg of oral colchicine or placebo, 1 to 2 hours before catheterization. More than half of the patients had ACS and the majority had complex coronary disease. The primary outcome of PCI-related myocardial injury, based on troponin changes according to the universal definition of MI, was no different between groups, occurring in 57.3% of colchicine-treated patients and 64.2% of placebo-treated subjects (P = 0.19). Likewise, no differences were seen for a range of 30-day MACE outcomes.
For the inflammatory biomarker sub study, investigators saw no between-group difference in the primary biomarker endpoint of percent change in plasma IL-6 concentration between baseline and 1 hour post-PCI. However, a number of secondary biomarker endpoints were promising. These included minimal changes from baseline to 22-24 hours post-PCI in the colchicine group both in high-sensitivity C-reactive protein (hsCRP) and plasma IL-6 concentration, changes that were significantly less than those seen in placebo-treated patients. Of note, there was no difference seen in terms of treatment effects according to whether patients had ACS as the indication for PCI, presence or absence of an intraprocedural complication, or statin therapy status.
“Compared with placebo, short-term preprocedural colchicine did not reduce PCI-related myocardial injury or MACE at 30 days, but did attenuate PCI-related increases in IL-6 and hsCRP concentration at 24-hours post-PCI,” concluded Binita Shah. “This is the first study to demonstrate that an oral load of colchicine prevents a rise of inflammatory biomarkers in acute injury.”
What is Colchicine
Colchicine is a medication used to treat gout and Behcet’s disease. For gout, it is less preferred to NSAIDs or steroids. Other uses include the prevention of pericarditis and familial Mediterranean fever. The drug is consumed orally. It is a form of autumn crocus and safely used as early as 1500 BC to treat joint swelling. It was approved for medical use in the United States in 1961. It is available as a generic medication in the UK where a month’s supply costs the NHS about £7.27, as of 2019. In the U.S., the wholesale cost of this amount is about $252.20.
Subodh Verma, MD, University of Toronto/St. Michael’s Hospital, Canada, reports that the study was “important” and noted that investigators should take note and utilize observations in any published materials including the information on baseline inflammatory markers. For example, he noted that analysis of the CANTOS trial suggested that patients who responded the most to canakinumab, another anti-inflammatory agent, appeared to derive the greatest benefit from the therapy.
Verma suggests that perhaps the emerging data on colchicine leads to the possibility that It could play an important role in patients following an MI, as per the COLCOT study. This data may also reveal importance in the acute, peri-STEMI period, a question being studied in the 4000-patient, CLEAR SYNERGY (OASIS 9) trial. TCTMD noted that Verrma concluded that as far as the role for colchicine in the PCI setting he is not certain of an answer as of yet. In fact, TCTMD reported that Shah told them it was still worth investigating in addition to exploring “longer duration of therapy and different doses of the drug.” TCTMD also reports that Shah is conducting a biomarker sub study within the CLEAR SYNERGY trial.
Binita Shah, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NYSource: tctMD