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PHILADELPHIA -- Gout drug colchicine may help in preventing new ischemic events after heart attack, but the early signals are less promising for the percutaneous coronary intervention (PCI) setting.
A single dose given at the time of catheterization didn't reduce PCI-related myocardial injury as indicated by plasma interleukin (IL)-6 concentration from baseline to 1 hour compared with placebo (57.3% vs 64.2%, P=0.19) in the inflammatory marker substudy.
Nor were there fewer 30-day major adverse cardiovascular events (11.7% vs 12.9%, P=0.82), Binita Shah, MD, of the VA New York Harbor Healthcare System in New York City, reported here at the American Heart Association meeting.
Additional secondary endpoints, though, did show less IL-6 at 22-24 hours post-PCI with the drug than with placebo. High sensitivity C-reactive protein, another inflammatory marker, also favored the drug.
Shah was optimistic about those secondary benefits, but a more cautious view came from Subodh Verma, MD, PhD, of the University of Toronto and study discussant at the meeting's late-breaking clinical trial session.
He pointed to the single loading dose of 1.8 mg colchicine and an "aggressive" statistical power looking for a 40% improvement in the primary IL-6 endpoint as possible factors.
"The story is not over," he said. The randomized is underway, he noted, and powered for a hard outcome endpoint with 4,000 ST-segment elevation MI patients referred for PCI randomized to colchicine or spironolactone.
For colchicine, "if you had a recent MI, I think the answer is a resounding yes," Verma said, referring to the positive findings released at the same conference from the COLCOT trial with colchicine in that setting.
"What about pre- or peri-PCI? I don't think we're there yet based on what we heard today," he added. "But more studies are needed that target residual inflammatory risk and potentially couple this acute loading dose with a chronic ongoing treatment. And of course, we also need high-risk primary prevention studies."
The Colchicine-PCI inflammatory marker substudy was nested within the single-center trial primarily looking at peri-procedural myocardial necrosis measured by troponin and also secondarily at hard outcomes out to 5 years.
The substudy included 400 adults with suspected ischemic heart disease or acute coronary syndromes referred for clinically-indicated coronary angiography with possible PCI. The double-blind trial randomized patients to oral administration of 1.8 mg of colchicine or placebo in the 1 hour before the procedure.
Limitations included an almost entirely male population enrolled within the VA system and lack of data on genetic predisposition to colchicine resistance.
Disclosures
Shah disclosed relationships with Philips Volcano and Radux.
Verma disclosed relationships with Amgen, Janssen, Boehringer-Ingelheim/Lilly, Merck, Bayer, Novo Nordisk, and AstraZeneca.
Primary Source
American Heart Association
Shah B "Colchicine in Percutaneous Coronary Intervention" AHA 2019.