Icosapent Ethyl Reduces Ischemic Events in Patients With a History of Previous Coronary Artery Bypass Grafting: REDUCE-IT CABG

Abstract

Background: Despite advances in surgery and pharmacotherapy, there remains significant residual ischemic risk following coronary artery bypass grafting (CABG) surgery. Methods: In the multicenter, placebo-controlled, double-blind trial REDUCE-IT, statin-treated patients with controlled low-density lipoprotein cholesterol (LDL-C) and mild to moderate hypertriglyceridemia were randomized to 4g daily of icosapent ethyl or placebo. They experienced a 25% reduction in risk of a primary efficacy endpoint (cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina) and a 26% reduction in risk of a key secondary efficacy endpoint (cardiovascular death, myocardial infarction, or stroke) when compared with placebo. The present analysis reports on the subgroup of patients from the trial with a history of CABG. Results: Of the 8,179 patients randomized in REDUCE-IT, a total of 1,837 (22.5%) had a history of CABG, with 897 patients randomized to icosapent ethyl and 940 to placebo. Baseline characteristics were similar between treatment groups. Randomization to icosapent ethyl was associated with a significant reduction in the primary endpoint (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.63-0.92; P=0.004), in the key secondary endpoint (HR, 0.69; 95% CI, 0.56-0.87; P=0.001), and in total (first plus subsequent or recurrent) ischemic events (rate ratio, 0.64; 95% CI, 0.50-0.81; P=0.0002) compared with placebo. This yielded an absolute risk reduction of 6.2% (95% CI, 2.3%-10.2%) in first events, with a number needed to treat of 16 (95% CI, 10-44) over a median follow-up time of 4.8 years. Safety findings were similar to the overall study: beyond an increased rate of atrial fibrillation/flutter requiring hospitalization for at least 24 hours (5.0% vs. 3.1%; P=0.03) and a non-significant increase in bleeding, occurrences of adverse events were comparable between groups. Conclusions: In REDUCE-IT patients with a history of CABG, treatment with icosapent ethyl was associated with significant reductions in first and recurrent ischemic events.

Pattern Changes in the Heart Rate Variability of Patients Undergoing Coronary Artery Bypass Grafting Surgery

“…The youngest patient was 38 years old and the oldest was 81 years old. The age of patients in this study is similar to that in published studies [ 20 ].…”

Benefits of icosapent ethyl for enhancing residual cardiovascular risk reduction: A review of key findings from REDUCE-IT

“…First primary composite endpoint events of cardiovascular death, nonfatal stroke, nonfatal MI, coronary revascularization or unstable angina were reduced by 24% in those treated with IPE compared with placebo (HR 0.76, 95% CI 0.63-0.92, P = 0.004). 24 There was also an absolute risk reduction of 6% for the key secondary composite endpoint among those treated with IPE versus placebo (14.7% versus 20.7%, HR 0.69, 95% CI 0.56-0.87, P = 0.001). 24 Fatal or nonfatal myocardial infarction was significantly lower in the IPE cohort (8.2% versus 13.3%, HR 0.60, 95% CI 0.45-0.81, P = 0.0005).…”

“…24 There was also an absolute risk reduction of 6% for the key secondary composite endpoint among those treated with IPE versus placebo (14.7% versus 20.7%, HR 0.69, 95% CI 0.56-0.87, P = 0.001). 24 Fatal or nonfatal myocardial infarction was significantly lower in the IPE cohort (8.2% versus 13.3%, HR 0.60, 95% CI 0.45-0.81, P = 0.0005). There was a trend towards a reduction in the incidence of cardiovascular death ( P = 0.06).…”

“…6 Significant reductions in first and subsequent events related to the primary composite endpoint among patients with a history of prior coronary artery bypass graft surgery treated with icosapent ethyl versus placebo. Published with permission from Verma et al 24…”

The potential population health impact of treating REDUCE-IT eligible US adults with Icosapent Ethyl

“…In REDUCE-IT, [ 6 , 7 , [11] , [12] , [13] , [14] , [15] ] participants were eligible for enrollment if they were 50 years of age and had diabetes and at least one additional risk factor (primary prevention group) or 45 years of age or older and had pre-existing ASCVD (secondary prevention group). Participants had to have a fasting TG level of 135-499 mg/dL and low-density lipoprotein cholesterol (LDL-C) level of 41-100 mg/dL while taking a stable dose of a statin for at least four weeks.…”