Trial reportCirculation2021

Reduction in Revascularization With Icosapent Ethyl: Insights From REDUCE-IT Revascularization Analyses.

Benjamin E Peterson, Deepak L Bhatt, Ph Gabriel Steg, Michael Miller, Eliot A Brinton, Terry A Jacobson, Steven B Ketchum, Rebecca A Juliano, Lixia Jiao, Ralph T Doyle and 9 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2021. The graph read 1 number from its abstract, feeding 2 cells of the map: it . It reports registered trial NCT01492361. Cited by 28 papers, 1 of them a synthesis that pooled it.

1number the graph read from it
2cells of the map it votes in
28citing papers in PubMed, 1 pooled it
9.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

← favours the treatmentfavours the comparator →
1 · no effect
Cardiovascular eventsfavours the treatment · head-to-head · ascvd, t2dfeeds 2 cells of the map
HR 0.660.58 to 0.76
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]; CONCLUSIONS: Icosapent ethyl reduced the need for first and subsequent coronary revascularizations in statin-treated patients with elevated triglycerides and increased cardiovascular risk.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Cardiac procedures & devices×cardiovascular events

No readable resultOpen on the map →What to test next →

3 readable studies in this cell: 2 favour the treatment, 0 find no difference, 1 favour the comparator.

Belief with this paper
0.50contested · 3 families support, 2 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
1 · no effect

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

Other lipid agents×cardiovascular events

No readable resultOpen on the map →What to test next →

10 readable studies in this cell: 5 favour the treatment, 5 find no difference, 0 favour the comparator.

Belief with this paper
0.80established · 4 families support, 1 contradict · against placebo
Without it
0.50This paper moves it by +0.30. It would be contested.
← favours the treatmentfavours the comparator →
1 · no effect
NCT0020287818,144 enrolled · 2005
HR 0.940.89 to 0.99
NCT0061899526 enrolled · 2007
Geometric least-squares mean ratio 0.940.77 to 1.14

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01492361 phase3completed

Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial)

Ran2011Enrolled8,179Registered outcomes10Posted comparisons10ConditionsCardiovascular DiseasesArmsAMR101, Placebo, Statin therapy
Open the trial in the graph
5 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 56 citations in OpenAlex.

  1. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
  14. Do patients benefit from omega-3 fatty acids?Cardiovascular research · 2024
    Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Article
6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

19 authors at 11 institutions in 5 countries.

Benjamin E PetersonBrigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (B.E.P, D.L.B., R.P.G.).
Deepak L BhattBrigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (B.E.P, D.L.B., R.P.G.).
Ph Gabriel StegUniversité de Paris, AP-HP (Assistance Publique-Hôpitaux de Paris), Hôpital Bichat, FACT (French Alliance for Cardiovascular Trials), INSERM U-1148, France (Ph.G.S.).
Michael MillerDepartment of Medicine, University of Maryland School of Medicine, Baltimore (M.M.).
Eliot A BrintonUtah Lipid Center, Salt Lake City (E.A.B.).
Terry A JacobsonOffice of Health Promotion and Disease Prevention, Department of Medicine, Emory University School of Medicine, Atlanta, GA (T.A.J.).
Steven B KetchumAmarin Pharma, Inc (Amarin), Bridgewater, NJ (S.B.K., R.A.J., L.J., R.T.D., C.G.).
Rebecca A JulianoAmarin Pharma, Inc (Amarin), Bridgewater, NJ (S.B.K., R.A.J., L.J., R.T.D., C.G.).
Lixia JiaoAmarin Pharma, Inc (Amarin), Bridgewater, NJ (S.B.K., R.A.J., L.J., R.T.D., C.G.).
Ralph T DoyleAmarin Pharma, Inc (Amarin), Bridgewater, NJ (S.B.K., R.A.J., L.J., R.T.D., C.G.).
Craig GranowitzAmarin Pharma, Inc (Amarin), Bridgewater, NJ (S.B.K., R.A.J., L.J., R.T.D., C.G.).
C Michael GibsonBaim Clinical Research Institute, Boston, MA (C.M.G., D.P.).
Duane PintoBaim Clinical Research Institute, Boston, MA (C.M.G., D.P.).
Robert P GiuglianoBrigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (B.E.P, D.L.B., R.P.G.).
Matthew J BudoffDavid Geffen School of Medicine, Lundquist Institute, Torrance, CA (M.J.B.).
Jean-Claude TardifMontreal Heart Institute, Université de Montréal, Montreal, QC, Canada (J.-C.T.).
Subodh VermaDivision of Cardiac Surgery, St Michael's Hospital, University of Toronto, ON, Canada (S.V.).
Christie M BallantyneDepartment of Medicine, Baylor College of Medicine, and Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (C.M.B.).
REDUCE-IT Investigators
Amarin (United States) · USBrigham and Women's Hospital · USBaim Institute for Clinical Research · USDeseret Laboratories (United States) · USEmory University · USHouston Methodist · USInserm · FRLos Angeles Biomedical Research Institute · USMontreal Heart Institute · CASt. Michael's Hospital · CAUniversity of Maryland, Baltimore · US

Funding

TRAINING PROGRAM IN CARDIOVASCULAR RESEARCHT32HL007604 · BRIGHAM AND WOMEN'S HOSPITAL · 1985 to 2025
$4.2M
NHLBI NIH HHS T32 HL007604
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundPatients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations.

methodsREDUCE-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.

resultsA 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];

conclusionsIcosapent 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.

Indexed as

AgedCardiovascular DiseasesDiabetes MellitusDouble-Blind MethodEicosapentaenoic AcidFemaleFollow-Up StudiesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedMyocardial RevascularizationPlatelet Aggregation InhibitorsEicosapentaenoic Acideicosapentaenoic acid ethyl esterHydroxymethylglutaryl-CoA Reductase InhibitorsPlatelet Aggregation Inhibitorseicosapentaenoic acidicosapent ethylmyocardial revascularizationprevention & control

Identifiers

PMID33148016
PMCPMC7752247
OpenAlexW3115888582

What Socratic holds

Texttitle and abstract
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.