Results of the late-breaking COLCOT trial, which explored the efficacy of low-dose colchicine in reducing CV risk in heart attack patients, were a highlight of the American Heart Association’s 2019 Scientific Sessions this month in Philadelphia.
Lead investigator Jean-Claude Tardif, MD, of the Montreal Heart Institute in Canada, presented his team’s findings at the meeting’s opening sessions Nov. 16, noting that COLCOT had achieved its primary goal of reducing the risk of CV death, cardiac arrest, MI, stroke or urgent angina hospitalization in patients who’d experienced an MI within the past month. The phase 3, double-blinded trial enrolled 4,745 heart patients and randomized them 1:1 to either 0.5 milligrams of colchicine daily or a placebo.
All patients were receiving standard of care—including statins, antiplatelet agents and PCI, if planned—at the study’s baseline. While the full study population continued to receive those therapies for the duration of the trial, half supplemented their routine with colchicine, an anti-inflammatory currently indicated for gout and pericarditis.
Tardif said colchicine made sense as a potential therapy for patients after MI since that’s a period of intense inflammation.
“The search for a widely used anti-inflammatory treatment that might reduce the risk of atherosclerotic events in patients with CVD continues,” he said at a press briefing. “There is ample evidence that supports the role of inflammation in atherosclerosis both at initiation [and] progression, as well as the complications of atherosclerosis that lead to acute coronary syndromes.”
The mean interval between heart attack and randomization in the study was 13 days. Standard of care at baseline was good, Tardif said, with 93% of patients having undergone angioplasty and 99%, 98% and 99% actively taking aspirin, a second antiplatelet or statins, respectively.
After an average follow-up of nearly 23 months, the authors said 5.5% of patients on colchicine had met the study’s composite primary endpoint of CV death, resuscitated cardiac arrest, MI, stroke or urgent angina hospitalization with revascularization. That number was 7.1% in the placebo group, reflecting a 23% risk reduction with colchicine.
Tardif said hazard ratios (HRs) seemed to favor colchicine for each component of the composite endpoint, with HRs of 0.84 for CV death, 0.83 for cardiac arrest, 0.91 for MI, 0.26 for stroke and 0.50 for urgent hospitalziation for angina. Nausea was reported more often in the colchicine group, though (1.8% vs. 1% of patients in the placebo group), as was pneumonia (0.9% vs. 0.4%).
“COLCOT shows that colchicine at a low dose significantly reduced the risk of first and total ischemic cardiovascular events by 23% and 34%, respectively, compared to placebo in patients with recent MI,” Tardif said. “The drug was well-tolerated on the background of standard care. Obviously, the COLCOT results apply to patients who have recently suffered an MI, and so further research is needed to assess the benefits of colchicine in other high-risk patients.”
On that note, Tardif announced his team’s new COLCOT-T2D trial, which will explore the efficacy of low-dose colchicine in reducing CV risk in 10,000 patients with type 2 diabetes mellitus and no history of coronary disease.