Icosapent ethyl: evidence and guidelines recommendations

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Residual cardiovascular risk:
what is the role of icosapent ethyl?
Prof. Xavier Garcia-Moll
Hospital de la Santa Creu i Sant Pau, Barcelona (Spain)

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Xavier Garcia-Moll
Icosa pento de etilo (IPE): indications as per technical data sheet

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Xavier Garcia-Moll
Major randomised studies with EPA:
• REDUCE-IT
• EVAPORATE

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Xavier Garcia-Moll
REDUCE-IT trial
• Randomised trial; multicentric; double blind; controlled (statin + IPE 2 g/12h vs statin + placebo)
• 8179 patients with established cardiovascular disease (70.7% of all patients included) or with T2D and other CV risk
factors, under treatment with statins and with high serum triglycerides (135 - 499 mg/dL or 1.52 - 5.63 mmol/L)
• Mean follow up: 4.9 years
• Primary composite endpoint: CV death, non fatal MI, non fatal stroke, coronary revascularisation, or unstable angina
• Key secondary endpoint: composed of CV death, non fatal MI, or non fatal stroke
Bhatt DL, et al. N Engl J Med 2019;380:11-22

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Xavier Garcia-Moll
REDUCE-IT trial

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Xavier Garcia-Moll
REDUCE-IT trial
Primary composite endpoint: CV death, non fatal MI, non fatal stroke,
coronary revascularisation, or unstable angina Key secondary endpoint: CV death, non fatal MI or non fatal stroke
RRR=24.8%
ARR: 4.8%
NNT: 21 (95%CI 15-33)
28.3%
23.0% RRR=26.5%
ARR: 3.6%
NNT: 28 (95%CI 20-47)
20.0%
16.2%

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Xavier Garcia-Moll
REDUCE-IT trial

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REDUCE-IT trial
Safety:

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Xavier Garcia-Moll
Bhatt DL, et al. JACC. 2019;73:2791-2802
REDUCE-IT trial: pre-specified subgroup analysis
Total episodes reduction throughout study lenght

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Xavier Garcia-Moll
Bhatt DL, Steg PG, Miller M, et al., ESC 2021 (virtual)
Primary endpoint reduction in patients with prior MI

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Xavier Garcia-Moll
Primary endpoint reduction in patients with prior surgical revascularisation
Verma S, et al. Circulation. 2021;144:1845–1855.

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Xavier Garcia-Moll
Majithia A, et al. Circulation. 2021;144:1750–1759.
Primary endpoint reduction in patients depending on their renal function

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Xavier Garcia-Moll
Peterson BE, et al. Circulation. 2021;143:33–44.
39% reduction of urgent/emergent
revascularisation: first non anti-LDL molecule to
achieve these results
Reduction of revascularisations
Time to coronary revascularisation (urgent or elective) from randomisation: intention to treat analysis
Urgent and elective; first, second, third;
percutaneous or surgical

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Xavier Garcia-Moll
Arbel R, et al. Am J Med 2021; https://doi.org/10.1016/j.amjmed.2020.12.023
Primary Prevention Secondary Prevention
Control arm event rate 13.62% 25.51%
IPE Hazard Ratio (95% CI) 0.876 (0.7 – 1.095) 0.726 (0.65 – 0.81)
IPE arm event rate (95% CI) 13.62%*0.876 = 11.93%
(9.53% - 14.91%)
25.51%*0.726=18.52%
(16.58% - 20.68%)
Absolute risk reduction (%) (95% CI) 13.62%*11.93% = 1.689%
(4.085% - (-1.29%))
25.51%*18.52% = 6.976%
(4.87% - 8.95%)
Number needed to treat (95% CI) 1/1.689% = 59 (24 - ∞) 1/6.976% = 14 (11 – 21)
Primary endpoint reduction in Primary Prevention patients and in Secondary Prevention patients

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Xavier Garcia-Moll
Budoff MJ, et al. Eur Heart J;2020;41:3925–3932
EVAPORATE trial
• Randomised study, double blind, controlled (statin + EPA 4 g/day vs statin + placebo)
• 80 patients with coronary atherosclerosis as per coronary CT scan (1 or more stenoses ≥20%), treated with
statins and with triglycerides persistently high
• Coronary CT scan at month 9 and at the end of the study (18 months)
• Primary endpoint: change in volume of low-attenuation plaque (LAP) at month 18 between EPA group and
placebo group

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Xavier Garcia-Moll
EVAPORATE trial
Budoff MJ, et al. Eur Heart J;2020;41:3925–3932

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EMA indication for IPE:

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Mineral oil in placebo group in REDUCE-IT:

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Xavier Garcia-Moll
Tokgozoglu L, et al. Eur Heart J 2021; doi:10.1093/eurheartj/ehab875

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Xavier Garcia-Moll
Dawson, L.P. et al. J Am Coll Cardiol. 2022;79(1):66–82.

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Xavier Garcia-Moll
• EUROASPIRE Risk Calculator: https://www.calconic.com
• SMART-REACH calculator: u-prevent.com
• DIAL model: Berkelmans GFN, et al. Eur Heart J 2019;40(34):2899-2906

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Xavier Garcia-Moll

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Xavier Garcia-Moll
Conclusions
From a clinical perspective:
• REDUCE-IT trial reduces main endpoint by 25% (HR 0.75; NNT 21)
• REDUCE-IT trial reduces secondary endpoint by 28% (HR 0.76; NNT 28)
• When compared with placebo, 4 g a day de icosapent etil reduced
• 20% CV death
• 31% MI
• 28% stroke
• NNT in secondary prevention to prevent an episode of the main endpoint was 14
• Coronary anatomy studies have shown that it modifies plaque composition
• In addition of lowering serum triglycerides, there is a clinical benefit

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Xavier Garcia-Moll
What do guidelines recommend:
• It is recommended to assess residual risk in high CV risk patients
• It is important to measure non-HDL cholesterol and triglycerides in patients with
high CV risk
• In high CV risk patients with LDL-cholesterol levels within range, treatment of high
triglycerides receive IIA/ IIB recommendations in the ESC guidelines
Conclusions -2-

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Xavier Garcia-Moll
Thank you for your attention
@xgmoll

Icosapent ethyl: evidence and guidelines recommendations

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Icosapent ethyl: evidence and guidelines recommendations