March 22, 2023

3 min read

Steg PG, et al. Highlighted Original Research: Ischemic Heart Disease and the Year in Review. Presented at: American College of Cardiology Scientific Session; March 4-6, 2023; New Orleans (hybrid meeting).

Disclosures: REDUCE-IT was funded by Amarin. Steg reports receiving consultant fees/honoraria from Amarin, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Idorsia, Novartis, Novo Nordisk, Pfizer, PhaseBio, Regeneron and Sanofi Aventis; receiving research grants from Bayer, Merck, Sanofi Aventis and Servicer and speaking for Amgen.

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NEW ORLEANS In patients with elevated triglycerides and recent ACS, icosapent ethyl reduced risk for first and total ischemic events compared with placebo, according to new data from the REDUCE-IT trial.

As Healio previously reported, in the main results of REDUCE-IT, icosapent ethyl (Vascepa, Amarin), a pharmaceutical-grade omega-3 fatty acid, was superior to placebo for reducing risk for ischemic events in patients with elevated triglycerides at high CV risk despite statin therapy. P. Gabriel Steg, MD, chief of the cardiology department at Hpital Bichat, Paris, and professor of cardiology at the Universit de Paris, presented at the American College of Cardiology Scientific Session a post hoc analysis of REDUCE-IT covering 840 patients from the trial who had ACS, defined as MI or unstable angina, within 12 months before enrollment.

Steg told Healio that the post hoc analysis was undertaken because the main results showed that the icosapent ethyl group had elevated risk for atrial fibrillation or flutter, as has typically been observed with omega-3 fatty acids, and modestly elevated risk for bleeding compared with the placebo group.

Because of that, there were concerns that in patients with recent ACS who are particularly high risk for cardiovascular events, who have a higher risk for atrial fibrillation and who often receive intensive antithrombotic therapy including dual antiplatelet therapy, there might be a greater propensity for bleeding or atrial fibrillation or flutter, and it was uncertain whether benefit would be less, equal to or larger than in the overall population, he said in an interview.

Among the cohort, the median age was 59.5 years, 77% were men, 36.9% had diabetes, 99.9% were on statin therapy and 95.8% were on antiplatelet therapy. The primary endpoint was a composite of CV death, nonfatal MI, nonfatal stroke, coronary revascularization or unstable angina.

Steg and colleagues found that at a median follow-up of 5 years, compared with the placebo group, the icosapent ethyl group had 37% reduced risk for first primary endpoint event (HR = 0.63; 95% CI, 0.48-0.84; P = .002) and 36% reduced risk for total primary endpoint events (RR = 0.64; 95% CI, 0.45-0.9; P = .01).

In patients with recent ACS, the absolute risk reduction of first events with icosapent ethyl at 5 years was 9.3% and the number needed to treat to present one first event was 11, which Steg said was remarkable, whereas in patients with ACS more than 12 months before enrollment, the absolute risk reduction of first events with icosapent ethyl at 5 years was 4.7% and the number needed to treat to present one first event was 21 (P for interaction = .16), according to the researchers.

Among those with recent ACS, the icosapent ethyl group was more often hospitalized for AF or flutter (4.8% vs. 1.7%; P = .01), and there was no difference between the groups in bleeding rates (icosapent ethyl, 6.9%; placebo, 8.1%; P = .6), Steg and colleagues found.

It seems that icosapent ethyl is remarkably beneficial in this subgroup of patients and is safe, so [there is] no reason to deny those patients, withhold therapy or delay starting therapy with icosapent ethyl, Steg told Healio.

In fact, Steg said, We should be particularly careful not to miss these patients early on because of the magnitude of the benefit in that high-risk patient population. This seems to be an effective preventive measure to take in post-ACS patients in those who are eligible: statin-treated adults post-ACS with an LDL between 40 mg/dL and 100 mg/dL and elevated triglycerides between 150 mg/dL and 500 mg/dL. Weve computed that this is approximately one of eight patients. So its not for everybody, but for those who qualify, theres quite a good deal there.

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