New REDUCE-IT analysis shows benefits of icosapent ethyl in patients with prior MI
Click Here to Manage Email Alerts
In patients with prior MI from the REDUCE-IT cohort, icosapent ethyl reduced risk for first and total CV events compared with placebo, according to new data presented at the European Society of Cardiology Congress.
In the overall REDUCE-IT trial, in high-risk patients with elevated triglycerides but normal LDL, icosapent ethyl (Vascepa, Amarin), a pharmaceutical-grade omega-3 fatty acid, reduced risk for first occurrence of the primary endpoint CV death, nonfatal MI, nonfatal stroke, coronary revascularization or unstable angina by 25% compared with placebo, and reduced risk for total primary endpoint events by 30%. Healio previously reported the results.
At the ESC Congress, Deepak L. Bhatt, MD, MPH, executive director of interventional cardiology programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, presented an analysis of 5-year results of patients enrolled in REDUCE-IT who had prior MI (n = 1,870 in the icosapent ethyl group and n = 1,823 in the placebo group).
“Patients with prior MI are known to be at high risk. We wanted to see how the REDUCE-IT data would look in this subgroup of interest,” Bhatt, the Cardiology Today Intervention Section Editor, told Healio.
In that cohort, the icosapent ethyl group had 26% reduced risk for first primary endpoint events (HR = 0.74; 95% CI, 0.65-0.85; P = .00001) and 35% reduced risk for total primary endpoint events (RR = 0.65; 95% CI, 0.56-0.77; P = .0000001) compared with the placebo group at 5 years, Bhatt said during the presentation.
The icosapent ethyl group also had reduced risk for the key secondary endpoint of CV death, MI and stroke compared with the placebo group, both in terms of first events (HR = 0.71; 95% CI, 0.61-0.84; P = .00006) and total events (RR = 0.68; 95% CI, 0.57-0.82; P = .00005), Bhatt said.
The icosapent ethyl group had lower risk for the following outcomes compared with placebo: CV death/nonfatal MI, MI, urgent or emergent revascularization, CV death, hospitalization for unstable angina, all-cause death/nonfatal MI/nonfatal stroke and all-cause death.
Results did not vary based on whether patients were treated with revascularization or conservative management for their prior MI, Bhatt said.
Icosapent ethyl also conferred reduced risk for sudden cardiac death (HR = 0.6; 95% CI, 0.38-0.94; P = .02) and cardiac arrest (HR = 0.44; 95% CI, 0.21-0.8; P = .02), according to the results.
“We can get a sense of when this becomes consistently statistically significant, and that ends up being around 4 years for both of these endpoints,” Bhatt said. “Benefit for, say, time to coronary revascularization seems to kick in pretty early, by around 12 months or so; here, for harder events, such as sudden cardiac death and cardiac arrest, it appears that it takes a longer duration of therapy for those benefits to start to become fully manifest.”
Consistent with the results in the overall cohort, tolerability and adverse events did not differ between the groups, while the icosapent ethyl group had higher rates of bleeding and atrial fibrillation/atrial flutter, Bhatt said.
“The overall REDUCE-IT trial was robustly positive, with consistency across multiple prespecified subgroups. We anticipated that the prior MI subgroup would also be consistent with the overall positive trial, and it was,” Bhatt told Healio. “In addition, the benefit was seen in patients managed with revascularization in the past or managed medically. The large and significant reductions in cardiovascular death, including sudden cardiac death and cardiac arrest, should be of particular interest to cardiologists and primary care physicians. Patients with prior MI, and other patients who would have been eligible for REDUCE-IT based on triglyceride elevation, should be screened to see if they are appropriate candidates for icosapent ethyl.”
Collapse
Bhatt DL, et al. Latest Science in ACS. Presented at: European Society of Cardiology Congress; Aug. 27-30, 2021 (virtual meeting).
Click Here to Manage Email Alerts