Evidence map›Paper›PMID 34325831›Full record

Trial reportJournal of the American College of Cardiology2021

Lipoprotein(a) and Benefit of PCSK9 Inhibition in Patients With Nominally Controlled LDL Cholesterol.

Gregory G Schwartz, Michael Szarek, Vera A Bittner, Rafael Diaz, Shaun G Goodman, J Wouter Jukema, Ulf Landmesser, Patricio López-Jaramillo, Garen Manvelian, Robert Pordy and 5 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01663402. Cited by 80 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 5 pooled it
20.1field-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.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · 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.

NCT01663402 phase3completed

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

Ran2012Enrolled18,924Registered outcomes15Posted comparisons6ConditionsAtherosclerotic Cardiovascular DiseaseArmsAlirocumab, LMT, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 5 syntheses or guidelines pooled it, 131 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
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  9. Review
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  11. Article
  12. Observational
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  14. Leveraging Mendelian randomization to inform drug discovery and development for ischemic stroke.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2026
    Review
  15. Article
  16. Article
  17. Review
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  19. Phenomapping of subgroups in high-Lp(a) patients: a data-driven cluster analysis in RED-CARPET study.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Article
  20. Article

20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 16 institutions in 10 countries.

Gregory G SchwartzDivision of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA. Electronic address: gregory.schwartz@cuanschutz.edu.
Michael SzarekState University of New York, Downstate School of Public Health, Brooklyn, New York, USA; CPC Clinical Research and Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA.
Vera A BittnerDivision of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Rafael DiazEstudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.
Shaun G GoodmanCanadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada; St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
J Wouter JukemaDepartment of Cardiology, Leiden University Medical Center, Leiden, the Netherlands; Netherlands Heart Institute, Utrecht, the Netherlands.
Ulf LandmesserDepartment of Cardiology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Patricio López-JaramilloMasira Research Institute, Medical School (UDES), Bucaramanga, Colombia.
Garen ManvelianRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Robert PordyRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Michel ScemamaSanofi, Paris, France.
Peter R SinnaeveDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.
Harvey D WhiteGreen Lane Cardiovascular Services, Auckland City Hospital, Auckland, New Zealand.
Ph Gabriel StegUniversité de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, French Alliance for Cardiovascular Trials, and INSERM U1148, Paris, France; Imperial College, Royal Brompton Hospital, London, United Kingdom. Electronic address: https://twitter.com/gabrielsteg.
ODYSSEY Outcomes Committees and Investigators
Regeneron (United States) · USKU Leuven · BEState University of New York · USInserm · FRSt. Michael's Hospital · CAAuckland City Hospital · NZCharité - Universitätsmedizin Berlin · DEUniversity of Colorado Denver · USInstituto Cardiovascular de Rosario · ARUniversidad De Santander · COLeiden University Medical Center · NLSanofi (France) · FRSUNY Downstate Health Sciences University · USUniversity of Alabama at Birmingham · USUniversity of Colorado Anschutz Medical Campus · USUniversité de Montpellier · FR

Funding

Cardiac Calcification and Cholesterol Efflux in Older AdultsK23HL146982 · NHLBI · ALBERT EINSTEIN COLLEGE OF MEDICINE · PI BORTNICK, ANNA E · 2020 to 2024
$951k
NHLBI NIH HHS K23 HL146982
6 · The paper itself

Abstract

backgroundGuidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk.

objectivesIn a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels.

methodsODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was <70 mg/dL (median 69.4 mg/dL; interquartile range: 64.3-74.0 mg/dL); in 14,573 patients (77.0%), both determinations were ≥70 mg/dL (median 94.0 mg/dL; interquartile range: 83.2-111.0 mg/dL).

resultsIn the lower LDL-C subgroup, MACE rates were 4.2 and 3.1 per 100 patient-years among placebo-treated patients with baseline lipoprotein(a) greater than or less than or equal to the median (13.7 mg/dL). Corresponding adjusted treatment hazard ratios were 0.68 (95% confidence interval [CI]: 0.52-0.90) and 1.11 (95% CI: 0.83-1.49), with treatment-lipoprotein(a) interaction on MACE (P

conclusionsIn patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402).

Indexed as

Acute Coronary SyndromeAgedAntibodies, Monoclonal, HumanizedCardiovascular DiseasesCholesterol, LDLFemaleHumansLipoprotein(a)MaleMiddle AgedPCSK9 InhibitorsalirocumabAntibodies, Monoclonal, HumanizedCholesterol, LDLLipoprotein(a)PCSK9 Inhibitorsacute coronary syndromelipoprotein(a)low-density lipoprotein cholesterolPCSK9 inhibitor

Identifiers

PMID34325831
PMCPMC8822604
OpenAlexW3185845820

What OpenQuestion holds

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LicenceCC BY-NC-ND
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 OpenQuestion graph.