Trial reportEuropean heart journal2022

Alirocumab after acute coronary syndrome in patients with a history of heart failure.

Harvey D White, Gregory G Schwartz, Michael Szarek, Deepak L Bhatt, Vera A Bittner, Chern-En Chiang, Rafael Diaz, Shaun G Goodman, Johan Wouter Jukema, Megan Loy and 7 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2022. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. Cited by 16 papers, 2 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
16citing papers in PubMed, 2 pooled it
6.7field-weighted citation impact, top 2% 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 · against placebo · ascvd, heart_failurefeeds one cell of the map
HR 0.850.78 to 0.93P = 0.0001
Overall, alirocumab reduced MACE compared with placebo [hazard ratio (HR): 0.85; 95% confidence interval (CI): 0.78-0.93; P = 0.0001].

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.

PCSK9 inhibitors×cardiovascular events

SupportsOpen on the map →What to test next →

10 readable studies in this cell: 7 favour the treatment, 3 find no difference, 0 favour the comparator.

Belief with this paper
1.00established · 6 families support, 0 contradict · against placebo
Without it
1.00This paper does not move the number.
← favours the treatmentfavours the comparator →
1 · no effect
This paper · 2022
HR 0.850.78 to 0.93
NCT0176463327,564 enrolled · 2013
HR 0.850.79 to 0.92
NCT0166340218,924 enrolled · 2012
HR 0.850.78 to 0.93
NCT0387240112,301 enrolled · 2019
HR 0.750.65 to 0.86
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Is a PCSK9 Inhibitor Right for Your Patient? A Review of Treatment Data for Individualized Therapy.International journal of environmental research and public health · 2022
    Pooled it
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  6. Review
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6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

17 authors at 14 institutions in 9 countries.

Harvey D WhiteGreen Lane Cardiovascular Services, Auckland City Hospital, 5 Park Road, Grafton, Auckland, New Zealand.ORCID 0000-0001-7712-6750
Gregory G SchwartzDivision of Cardiology, University of Colorado School of Medicine, B130, Aurora, CO 80045, USA.
Michael SzarekDepartment of Epidemiology and Biostatistics, State University of New York, Downstate School of Public Health, 450 Clarkson Avenue, MS 43, Brooklyn, NY 11203, USA.ORCID 0000-0002-0046-0264
Deepak L BhattDepartment of Medicine, Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.ORCID 0000-0002-1278-6245
Vera A BittnerDivision of Cardiovascular Disease, University of Alabama at Birmingham, 701 19th Street South-LHRB 310, Birmingham, AL 35294, USA.ORCID 0000-0001-9456-850X
Chern-En ChiangGeneral Clinical Research Center, Taipei Veterans General Hospital and Taiwan School of Medicine, National Yang-Ming University, 201, Sec. 2, Shih-Pai road, Taipei, Taiwan.ORCID 0000-0002-1151-1047
Rafael DiazEstudios Clınicos Latino America, Instituto Cardiovascular de Rosario, Paraguay 160, Santa Fe, Rosario 2000, Argentina.ORCID 0000-0003-2181-9579
Shaun G GoodmanCanadian VIGOUR Centre, University of Alberta, 87 Ave NW, Edmonton, Alberta T6G 2E1, Canada.ORCID 0000-0001-8068-2440
Johan Wouter JukemaDepartment of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden 2333 ZA, the Netherlands.ORCID 0000-0002-3246-8359
Megan LoySanofi, 55 Corporate Dr, Bridgewater, NJ 08807, USA.
Neha PagidipatiDuke Clinical Research Institute, Duke University, School of Medicine, 300 W. Morgan St., NC 27701, USA.
Robert PordyRegeneron Pharmaceuticals, 777 Old Saw Mill River Rd, Tarrytown, NY 10591, USA.ORCID 0000-0002-8001-6795
Arsen D RistićDepartment of Cardiology, University Clinical Center of Serbia, Belgrade University School of Medicine, 8 Dr Subotića Street, Belgrade.
Andreas M ZeiherDepartment of Medicine III, Goethe University, Theodor-Stern-Kai 7, Frankfurt am Main 60590, Germany.ORCID 0000-0003-1711-5819
Daniel M WojdylaDuke Clinical Research Institute, Duke University, School of Medicine, 300 W. Morgan St., NC 27701, USA.
Philippe Gabriel StegAssistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, 46 Rue Henri Huchard, Paris, 75018 France.ORCID 0000-0001-6896-2941
ODYSSEY OUTCOMES Investigators
Duke University · USAuckland City Hospital · NZBrigham and Women's Hospital · USGoethe University Frankfurt · DEInserm · FRInstituto Cardiovascular de Rosario · ARLeiden University Medical Center · NLNational Yang Ming Chiao Tung University · TWRegeneron (United States) · USSanofi (United States) · USState University of New York · USSt. Michael's Hospital · CAUniversity of Alabama at Birmingham · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

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

aimsPatients with heart failure (HF) have not been shown to benefit from statins. In a post hoc analysis, we evaluated outcomes in ODYSSEY OUTCOMES in patients with vs. without a history of HF randomized to the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab or placebo. METHODS AND

resultsAmong 18 924 patients with recent acute coronary syndrome (ACS) receiving intensive or maximum-tolerated statin treatment, the primary outcome of major adverse cardiovascular events (MACE) was compared in patients with or without a history of HF. The pre-specified secondary outcome of hospitalization for HF was also analysed. Overall, 2815 (14.9%) patients had a history of HF. Alirocumab reduced low-density lipoprotein cholesterol and lipoprotein(a) similarly in patients with or without HF. Overall, alirocumab reduced MACE compared with placebo [hazard ratio (HR): 0.85; 95% confidence interval (CI): 0.78-0.93; P = 0.0001]. This effect was observed among patients without a history of HF (HR: 0.78; 95% CI: 0.70-0.86; P < 0.0001), but not in those with a history of HF (HR: 1.17; 95% CI: 0.97-1.40; P = 0.10) (Pinteraction = 0.0001). Alirocumab did not reduce hospitalization for HF, overall or in patients with or without prior HF.

conclusionAlirocumab reduced MACE in patients without a history of HF but not in patients with a history of HF. Alirocumab did not reduce hospitalizations for HF in either group. Patients with a history of HF are a high-risk group that does not appear to benefit from PCSK9 inhibition after ACS.

Indexed as

Acute Coronary SyndromeAnticholesteremic AgentsHeart FailureHydroxymethylglutaryl-CoA Reductase InhibitorsAntibodies, Monoclonal, HumanizedHumansProprotein Convertase 9Treatment OutcomealirocumabAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsHydroxymethylglutaryl-CoA Reductase InhibitorsPCSK9 protein, humanProprotein Convertase 9Acute coronary syndromesAlirocumabHeart failureMACEODYSSEY OUTCOMES

Identifiers

PMID34922353
PMCPMC9020985
OpenAlexW4200115483

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.