Abstract 10627: Benefits of Icosapent Ethyl in Patients with Prior Peripheral Artery Disease: REDUCE-IT PAD

Abstract

Introduction: REDUCE-IT found significant benefit in 8179 statin-treated patients randomized to icosapent ethyl (IPE). Whether that benefit extends to patients with peripheral artery disease (PAD) was unknown. Methods: The primary endpoint was time to cardiovascular (CV) death, myocardial infarction (MI), stroke, coronary revascularization, or hospitalization for unstable angina. The key secondary endpoint was CV death, MI, or stroke. Total (first plus recurrent) events were also assessed. PAD was an inclusion criterion in the established CV disease cohort. Prespecified and post hoc analyses by baseline history of PAD history were performed. Results: Of 5785 (70.7%) REDUCE-IT patients enrolled with established CV disease, 688 had PAD. IPE demonstrated statistically similar risk reduction in first (interaction P [p int ]=0.58) and total (p int =0.78) primary endpoints in patients with established CV disease with or without PAD, though PAD patients had higher first (placebo: 32.8% with vs 24.5% without PAD) and total (placebo: 162.3 vs 101.7 per 1000 patient-years) event rates. The primary endpoint event rate with PAD was 26.2% with IPE vs 32.8% with placebo (HR 0.78; 95% CI 0.59, 1.03; P=0.08) and total events were 112.8 per 1000 patient-years with IPE vs 162.3 with placebo (RR 0.68; 95% CI 0.48, 0.95; P=0.03) (Figure). Primary endpoint absolute risk reductions (ARR) and numbers needed to treat (NNT) suggest benefit for patients with (ARR 6.6%; NNT 15) and without (6.1%; 16) PAD. Safety did not differ substantially by PAD history and was generally consistent with the overall study. Conclusions: In REDUCE-IT, patients with PAD were at very high risk of subsequent ischemic events. IPE provided consistent CV benefit in patients with or without PAD.