COPS: Colchicine at index hospitalization through 1 year may reduce CV events in ACS
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In ACS, low-dose colchicine plus standard medical therapy for 12 months resulted in a lower, but statistically insignificant, rate of the composite primary outcome vs. placebo and standard therapy, a speaker reported.
However, when this randomized controlled COPS trial was extended to a 400-day follow-up, with participants halting colchicine at 365 days, investigators observed a significant reduction in the primary endpoint, driven by reduced incidence of urgent revascularization and unstable angina.
According to findings presented at the virtual European Society of Cardiology Congress, the COPS trial also demonstrated a greater incidence of noncardiac death among patients taking low-dose colchicine plus standard medical therapy compared with the placebo group.
“COPS demonstrated a reduction in major adverse cardiac events at 365 days, but was not significant, but became significant at 400 days. We saw an increase in events after 365 days when, in fact, colchicine was discontinued,” Jamie Layland, MBCHB, MRCP, FRACP, MD, PhD, FCSANZ, interventional cardiologist Peninsula Health in Melbourne, Australia, said during his presentation. “This raises the possibility that, perhaps, colchicine had some underlying plaque stability or plaque modulating effects and is translating to reductions in target vessel revascularization, acute coronary syndromes and stroke. But this is merely hypothesis generated.”
For this trial, investigators randomly assigned 795 hospitalized patients with ACS to low-dose colchicine plus standard medical therapy or placebo plus standard therapy for 12 months to assess whether colchicine initiation during index hospitalization affected CV outcomes. The primary composite outcome included all-cause mortality, ACS, ischemia-driven urgent revascularization and stroke. The secondary endpoint was the individual components of the primary endpoint, plus hospitalization for chest pain.
Follow-up at 356 and 400 days
At 365 days, patients who initiated colchicine at their index hospitalization for ACS experienced fewer occurrences of the primary outcome compared with the placebo group, but this association did not meet statistical significance (HR = 0.64; 95% CI, 0.38-1.09).
At 400-day follow-up, having ceased treatment at 365 days, patients who received colchicine experienced fewer occurrences of the composite endpoint compared with placebo, and this finding met statistical significance (HR = 0.6; 95% CI, 0.36-1.01).
Moreover, researchers noted significant reduction in urgent revascularization and unstable angina in the colchicine group compared with those who received placebo (HR = 0.25; 95% CI, 0.07-0.92).
More non-CV death
Patients in the colchicine group experienced greater incidence of non-CV death compared with the placebo group (HR = 0.51; 95% CI, 0.25-1.05).
“We did see a higher rate of non-CV death, and COLCOT, released last year, a much larger trial, had similar death rates between the placebo and treatment groups,” Layland said during the presentation. “However, they had a different dosing schedule with daily doses of colchicine and a longer duration of follow-up. It's possible that our high death rates, although small, reflect a higher dosing schedule, but most likely represents a shorter duration of follow-up and the smaller sample size. We are planning on doing a longer-term follow-up of COPS patients.”
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Layland J, et al. Impact of colchicine on cardiovascular disease. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 1, 2020 (virtual meeting).
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