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Coronary Revascularization

In a prespecified and exploratory analysis of adults on maximally tolerated statins with TG ≥150 mg/dL and established CVD or diabetes and ≥2 CVD risk factors

Shown to help reduce the risk of coronary revascularization events1,2

VASCEPA significantly reduced the need for coronary revascularizations across first and total events2,3

See Graph

34% RRR; NNT=24

ARR=4.1%; P=0.0000000008

Time to first coronary revascularization

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Time to first coronary revascularization

Adapted from Circulation, Vol 143, Peterson BE, Bhatt DL, Steg PG, et al. Reduction in revascularization with icosapent ethyl: insights from REDUCE-IT Revascularization Analyses, pp 33-44. Copyright 2021, with permission from Lippincott Williams & Wilkins.

At Year 5 since randomization, 1521 patients remained in the VASCEPA arm vs 1431 patients in the placebo arm.

ARR=absolute risk reduction; NNT=number needed to treat; RRR=relative risk reduction.

The curves were visually truncated at 5.7 years because a limited number of events occurred beyond that time point; all patient data were included in the analyses.

ARR is based on the observed rates of events of 9.2% for VASCEPA and 13.3% for placebo.

  • The CV event curve for VASCEPA separated from the placebo event curve at 11 months and remained separated throughout the follow-up period

VASCEPA also significantly reduced the time to total revascularization events by 36%; P=0.00000000052,3

REDUCE-IT® was not specifically powered to examine individual cardiovascular endpoints; therefore, P values presented for these revascularization analyses are nominal and exploratory with no adjustment for multiple comparisons. In addition, coronary revascularization as an endpoint can sometimes be considered subjective; however, these endpoints were adjudicated by an independent, blinded clinical endpoint committee. Results from the total coronary revascularization events analyses are consistent across the various recurrent event statistical models and are also consistent with the first coronary revascularization events results. Together, the REDUCE-IT first and total coronary revascularization events results support the robustness and consistency of the clinical benefit of VASCEPA therapy in reducing coronary revascularization.

See the data in Circulation

Reduction in revascularization was consistent across elective, emergent, and urgent events2,3

In a post-hoc analysis,

VASCEPA was observed to reduce PCI and CABG2,3

See Graph

32% RRR

P=0.0000002

Time to PCI

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Time to PCI

At Year 5 since randomization, 1548 patients remained in the VASCEPA arm vs 1474 patients in the placebo arm.

See Graph

39% RRR

P=0.0005

Time to CABG

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Time to CABG

At Year 5 since randomization, 1659 patients remained in the VASCEPA arm vs 1598 patients in the placebo arm.

Adapted from Circulation, Vol 143, Peterson BE, Bhatt DL, Steg PG, et al. Reduction in revascularization with icosapent ethyl: insights from REDUCE-IT Revascularization Analyses, pp 33-44. Copyright 2021, with permission from Lippincott Williams & Wilkins.

CABG=coronary artery bypass graft; PCI=percutaneous coronary intervention.

The curves were visually truncated at 5.7 years because a limited number of events occurred beyond that time point; all patient data were included in the analyses.

  • The CV event curves for VASCEPA appear to visually separate from the placebo event curve at approximately 1 year and remained separated throughout the follow-up period

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IMPORTANT SAFETY INFORMATION

• VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components

• VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter

• It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur

INDICATIONS AND LIMITATIONS OF USE

• VASCEPA® (icosapent ethyl) is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease

• VASCEPA is indicated as an adjunct to diet to reduce TG levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

• VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin

• Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%) and atrial fibrillation (5% vs 4%)

• Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%)

• Adverse Events, Product Complaints, or Special Situations may be reported by contacting AmarinConnect at 1-855-VASCEPA, emailing [email protected], or calling the FDA at 1-800-FDA-1088

• Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding

Please see full Prescribing Information for more information on VASCEPA.

Visual representations are for illustrative purposes only. The capsule shown is not an identical representation of the product.

References: 1. VASCEPA [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2021. 2. Peterson BE, Bhatt DL, Steg PG, et al. Reduction in Revascularization With Icosapent Ethyl: Insights From REDUCE-IT Revascularization Analyses. Circulation. 2021;143(1):33-44. 3. Peterson BE, Bhatt DL, Steg PG, et al. Reduction of revascularization in patients with hypertriglyceridemia with icosapent ethyl: insights from REDUCE-IT REVASC. Presented at: Society for Cardiovascular Angiography & Interventions 2020 Scientific Sessions; May 14-16, 2020; Virtual Conference.

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