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Effects of icosapent ethyl according to baseline residual risk in patients with atherosclerotic cardiovascular disease: results from REDUCE-IT.

Collaborators (1438)

Author information

Affiliations

  • 1. Department of Vascular Medicine, University Medical Centre Utrecht, Utrecht 3584 CX, the Netherlands.
      Authors
    • Burger PM 1
    • Dorresteijn JAN 1
    • Visseren FLJ 1
    (3 authors)
  • 2. Mount Sinai Heart, Icahn School of Medicine at Mount Sinai Health System, NY 10029, USA.
      Authors
    • Bhatt DL 2
    (1 author)
  • 3. Dutch Cardiovascular Research Network (WCN), Utrecht 3511 EP, the Netherlands.
      Authors
    • Koudstaal S 3
    • Mosterd A 3
    • Martens FMAC 3
    (3 authors)
  • 4. Université Paris-Cité, LVTS, French Alliance for Cardiovascular Trials (FACT), Assistance Publique-Hôpitaux de Paris, Paris 75018, France.
      Authors
    • Steg PG 4
    (1 author)

ORCIDs linked to this article

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European Heart journal. Cardiovascular Pharmacotherapy, 01 Oct 2024, 10(6):488-499
https://doi.org/10.1093/ehjcvp/pvae030 PMID: 38678009 

Abstract 

Aims

Icosapent ethyl lowers triglycerides and significantly reduces major adverse cardiovascular events (MACE), though treatment effects may vary between individuals. This study aimed to determine the relative and absolute effects of icosapent ethyl on MACE according to baseline cardiovascular disease (CVD) risk in patients with atherosclerotic cardiovascular disease (ASCVD).

Methods and results

Participants from the Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) with ASCVD were included (n = 5785). The primary outcome was 3-point MACE, i.e. non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death. Baseline 5-year risk of MACE was estimated using the European Society of Cardiology (ESC) guideline-recommended SMART2 risk score. Modification of the relative treatment effects of icosapent ethyl by baseline risk was assessed using Cox proportional hazards models, including a treatment-by-risk interaction. Next, treatment effects were assessed stratified by quartiles of baseline risk. During a median follow-up of 4.8 years (interquartile range 3.2-5.3), MACE occurred in 361 vs. 489 patients in the icosapent ethyl vs. placebo group [95% confidence interval (CI)]; hazard ratio (HR) 0.72 (0.63-0.82), absolute risk reduction (ARR) 4.4% (2.6-6.2%), number needed to treat (NNT) 23 (16-38), and 5-year Kaplan-Meier estimated cumulative incidence reduction (CIR) 5.7% (3.5-7.9%). Icosapent ethyl significantly reduced MACE in all risk quartiles, with an HR (95% CI) of 0.62 (0.43-0.88), 0.66 (0.48-0.92), 0.69 (0.53-0.90), and 0.78 (0.63-0.96), respectively (P for treatment-by-risk interaction = 0.106). The ARR (95% CI) increased across risk quartiles, i.e. was 3.9% (1.0-6.8%), 4.3% (1.2-7.3%), 5.1% (1.4-8.7%), and 5.6% (1.3-10.0%), respectively. This translates to NNTs (95% CI) of 26 (15-98), 24 (14-84), 20 (11-70), and 18 (10-77). The 5-year CIR (95% CI) was 4.8% (1.3-8.2%), 5.0% (1.3-8.7%), 6.1% (1.7-10.5%), and 7.7% (2.3-13.2%), respectively. Consistent results were obtained for 5-point MACE, additionally including coronary revascularization and unstable angina.

Conclusion

Among patients with ASCVD and elevated triglyceride levels, icosapent ethyl significantly reduces the risk of MACE irrespective of baseline CVD risk, though absolute benefits are largest for patients at the highest risk.

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Read article at publisher's site: https://doi.org/10.1093/ehjcvp/pvae030

Read article for free, from open access legal sources, via Unpaywall: https://academic.oup.com/ehjcvp/advance-article-pdf/doi/10.1093/ehjcvp/pvae030/57348158/pvae030.pdfUnpaywall

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Funding 

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Amarin Pharma