Colchicine, an anti-inflammatory medication, has failed to demonstrate a reduction in cardiovascular events following acute myocardial infarction (AMI), according to results from the CLEAR SYNERGY trial (OASIS 9). The findings, presented at a recent TCT press conference, have prompted leading cardiologists to reassess its role in post-MI treatment strategies.
The trial, a large-scale analysis, did not show a significant decrease in cardiovascular outcomes with colchicine use and revealed a notable side effect of diarrhea. "We believe this is important, because it should give clinicians pause," said principal investigator Sanjit S. Jolly, MD, MSc, of McMaster University. "On balance, when you look at this trial, we didn’t see a reduction in cardiovascular outcomes, and unfortunately there was a side effect of therapy, diarrhea. As a patient … would you want to take this therapy?"
Impact on Clinical Practice
The CLEAR SYNERGY data have already influenced clinical perspectives on using anti-inflammatory medications in AMI patients. Dr. Jolly, who previously supported colchicine, stated, "I was a believer in colchicine. I believed the data. My father had a myocardial infarction and I put him on colchicine—but I’ve just taken him off."
Ajay Kirtane, MD, SM, director of Columbia Interventional Cardiovascular Care at New York-Presbyterian/Columbia University Irving Medical Center, emphasized the significance of the findings, particularly in high-risk patients with substantial inflammation. "This is a very big deal to me," he said, noting the dissociation between CRP levels and clinical outcomes. He added that the already complex medication regimens for AMI patients make the addition of colchicine less appealing: "I would not want to start [colchicine] with a patient. I never wanted to start it with a patient anyway, and now I have good rationale for not doing so."
Trial Design and Results
The CLEAR SYNERGY trial (OASIS 9) was designed to evaluate the efficacy of colchicine in preventing cardiovascular events post-MI. While specific details of the trial's design, patient population, dosing, and endpoints were not available in the provided source, the primary outcome focused on cardiovascular events. The absence of a positive signal, coupled with the observed increase in diarrhea, led to the conclusion that colchicine does not offer a net benefit in this setting.
Future Directions
Despite the negative findings for colchicine, experts stress the continued importance of investigating post-MI inflammation. Wayne Batchelor, MD, director of interventional cardiology with Inova Heart and Vascular Institute, stated, "I’m not going to use colchicine. I think this was a terrific study, really well sample sized for the question, and there is no signal whatsoever other than diarrhea." However, he cautioned against abandoning the broader pursuit of treatments targeting post-MI inflammation.
Dr. Jolly noted that the full analysis has been accepted for publication in The New England Journal of Medicine.
