According to new results from the CLEAR SYNERGY (OASIS 9) trial, acute and long-term colchicine use does not reduce cardiovascular (CV) death, myocardial infarction (MI), stroke or ischemia-driven revascularization patients with acute MI. These results were presented by Sanjit Jolly, MD, MSc, of the Population Health Research Institute (PHRI) in Hamilton, Canada, during a late-breaking trial session on Tuesday at Transcatheter Cardiovascular Therapeutics (TCT) 2024. The results have also been accepted and will be published in the New England Journal of Medicine. Coronary artery disease (CAD) and acute coronary syndromes may, in-part, stem from inflammation in the body. In smaller studies, colchicine demonstrated potential in reducing inflammation in CV disease patients. “Inflammation post-myocardial infarction is a a very important thing to study,” commented panelist Wayne B. Batchelor, MD, MHS, of the Inova Heart and Vascular Institute, Fairfax, Virginia, in a news conference at TCT on Tuesday. The investigators in the CLEAR SYNERGY trial investigated the use of colchicine as treatment for patients with ST-segment elevation myocardial infarction (STEMI) or large non-STEMI (NSTEMI). The primary outcome of this large study was the reduction of a long-term composite of CV death, MI, stroke or ischemia-driven revascularization over the duration of follow-up. A total of 7,062 patients (mean age=60.6 years, 9% had prior MI) from 104 sites across 14 countries were included in the study and randomized to either colchicine or placebo within 72 hours of percutaneous coronary intervention (PCI). “I believed in colchicine; I had put my father on colchicine and now I’ve just recently taken him off,” Dr. Jolly said in the news conference. He went on to say that patients can choose whether or not to take this medication based on their preferences. The composite of CV death, MI, stroke or ischemia-driven revascularization did not differ between-groups at the median follow-up at 3-years (colchicine=9.1%, placebo=9.3%; hazard ratio=0.99; 95% CI=0.85-1.16; p=0.93). Additionally, no individual differences were noted in the components of the primary endpoint. Adverse events were also similar between-groups, except patients in the colchicine group had significantly more diarrhea (10.2% versus 6.6%, p<0.001). Ron Waksman, MD, director of Cardiovascular Research and Advanced Education at the Heart Institute at MedStar Washington Hospital Center, Washington, DC, interviewed Dr. Jolly on CardioTube on Tuesday and discussed future studies for colchicine. “I try to tie this to CRP because the mechanism, from my perspective on the way it was described, is reduction of inflammation...that’s how colchicine works. But it would be interesting when you look at CRP in general, if this hypothesis that lowering CRP on patients post-AMI has an impact on clinical events,” said Dr. Waksman. “Yeah, I think that’s a question whether future trials need to have a CRP inclusion,” said Dr. Jolly in the interview with Dr. Waksman. The former two colchicine trials on this topic did not have CRP criteria, Dr. Jolly noted. Overall, there was no significant difference in the composite outcome nor the individual components of CV death, MI, stroke or ischemia-driven revascularization in STEMI or NSTEMI patients who took colchicine versus placebo. Funding: PHRI, Canadian Institutes of Health, Boston Scientific Image Caption: Sanjit Jolly, MD, MSc, speaks during a news conference Tuesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC. Image Credit: Bailey G. Salimes/CRTonline.org