(VP015) BENEFITS OF ICOSAPENT ETHYL IN PATIENTS WITH RECENT ACUTE CORONARY SYNDROME (ACS): REDUCE-IT ACS

Background: In REDUCE-IT, icosapent ethyl (IPE) (4 g/d) reduced the primary endpoint by 25% (p < 0.0001). Patients with recent ACS ( < 12 months) are at very high risk of future CV events and receive intensive antithrombotic therapy.

METHODS AND RESULTS: In this post hoc REDUCE-IT analysis, first and total primary endpoints were examined in patients with recent ACS, defined as MI or unstable angina within 12 months before randomization. Of the 8179 patients, 840 (10.3%) had recent ACS. Their median age was 59.5 years, 76.9% were male, 36.9% had diabetes, 99.9% were on statins and 95.8% received antiplatelet therapy. In this subgroup, IPE reduced the risk of first and total primary endpoints by 37% (HR 0.63; 95% CI, 0.48-0.84, p=0.002) and by 36% (RR 0.64; 95% CI 0.45-0.90, p=0.01), respectively (Figure). The absolute risk reduction (ARR) in first endpoints over 5 years with IPE was 9.3% with an NNT of 11. The corresponding ARR was 4.7% (NNT=21) in the 3651 patients with ACS ≥ 12 months before randomization (interaction recent vs remote ACS p=0.16 for primary endpoint). In patients with recent ACS, a larger percentage of patients in the IPE group than in the placebo group were hospitalized for atrial fibrillation or flutter (4.8% vs 1.7% respectively, p=0.01); bleeding rates did not differ between treatments (6.9% vs 8.1% respectively, p=0.60).

Conclusion: IPE significantly reduced the risk of first and total ischemic events in patients with recent ACS without increased bleeding, supporting early initiation of IPE after ACS.