Reduction in Revascularization With Icosapent Ethyl: Insights From REDUCE-IT Revascularization Analyses
Benjamin E Peterson1, Deepak L Bhatt1, Ph Gabriel Steg2
1Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (B.E.P, D.L.B., R.P.G.).
Insights
Icosapent ethyl significantly reduced coronary revascularizations, including bypass surgery, in high-risk patients with elevated triglycerides on statin therapy. This non-statin treatment offers a new approach to prevent cardiovascular events.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Elevated triglycerides in patients on statin therapy are associated with a higher risk of ischemic events, such as coronary revascularizations.
- Identifying effective treatments to mitigate this risk is crucial for cardiovascular disease prevention.
Purpose of the Study:
- To evaluate the efficacy of icosapent ethyl in reducing coronary revascularizations in statin-treated patients with elevated triglycerides and increased cardiovascular risk.
- To analyze the impact of icosapent ethyl on various types of revascularization procedures.
Main Methods:
- The REDUCE-IT trial was a multicenter, double-blind, placebo-controlled study involving 8179 patients.
- Patients received either icosapent ethyl (4 g/d) or placebo, in addition to statin therapy.
- Follow-up was for a median of 4.9 years, with prespecified analyses of revascularization events.
Main Results:
- Icosapent ethyl reduced first revascularizations by 34% (HR, 0.66; P<0.0001) and total revascularizations by 36% (rate ratio, 0.64; P<0.0001).
- Significant reductions were observed across elective, urgent, and emergent revascularizations, including percutaneous coronary intervention and coronary artery bypass grafting.
- The number needed to treat for 4.9 years to prevent one revascularization was 24.
Conclusions:
- Icosapent ethyl effectively reduces the need for both first and subsequent coronary revascularizations in high-risk patients with elevated triglycerides on statin therapy.
- It is the first non-low-density lipoprotein-lowering therapy demonstrated to reduce coronary artery bypass grafting in a blinded, randomized trial.
Background:
Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations.
Methods:
REDUCE-IT (The Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial), a multicenter, double-blind, placebo-controlled trial, randomly assigned statin-treated patients with elevated triglycerides (135-499 mg/dL), controlled low-density lipoprotein (41-100 mg/dL), and either established cardiovascular disease or diabetes plus other risk factors to receive icosapent ethyl 4 g/d or placebo. The primary and key secondary composite end points were significantly reduced. Prespecified analyses examined all coronary revascularizations, recurrent revascularizations, and revascularization subtypes.
Results:
A total of 8179 randomly assigned patients were followed for 4.9 years (median). First revascularizations were reduced to 9.2% (22.5/1000 patient-years) with icosapent ethyl versus 13.3% (33.7/1000 patient-years) with placebo (hazard ratio, 0.66 [95% CI, 0.58-0.76]; P<0.0001; number needed to treat for 4.9 years=24); similar reductions were observed in total (first and subsequent) revascularizations (negative binomial rate ratio, 0.64 [95% CI, 0.56-0.74]; P<0.0001), and across elective, urgent, and emergent revascularizations. Icosapent ethyl significantly reduced percutaneous coronary intervention (hazard ratio, 0.68 [95% CI, 0.59-0.79]; P<0.0001) and coronary artery bypass grafting (hazard ratio, 0.61 [95% CI, 0.45-0.81]; P=0.0005).
Conclusions:
Icosapent ethyl reduced the need for first and subsequent coronary revascularizations in statin-treated patients with elevated triglycerides and increased cardiovascular risk. To our knowledge, icosapent ethyl is the first non-low-density lipoprotein-lowering treatment that has been shown to reduce coronary artery bypass grafting in a blinded, randomized trial. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361.
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