Evidence map›Paper›PMID 38325990›Full record

ArticleJournal of the American College of Cardiology2024

Long-Term Efficacy of Evolocumab in Patients With or Without Multivessel Coronary Disease.

Daniel J McClintick, Michelle L O'Donoghue, Gaetano M De Ferrari, Jorge Ferreira, Xinhui Ran, KyungAh Im, J Antonio G López, Mary Elliott-Davey, Bei Wang, Maria Laura Monsalvo and 4 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Journal of the American College of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03080935. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
11.5field-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.

NCT03080935 phase3terminated

A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

Ran2017Enrolled1,600Registered outcomes3Posted comparisons0ConditionsDyslipidemiaArmsEvolocumab
PMID 36031810other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. PCSK9 in critical illness - It's not all about lipids.Annals of clinical biochemistry · 2026
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  16. Development of a Prognostic Model for MACE in Atherosclerosis Based on MTHFR and Serum Markers.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 5 countries.

Daniel J McClintickDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Michelle L O'DonoghueTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Gaetano M De FerrariDepartment of Medical Sciences, University of Turin and Department of Cardiology, Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Turin, Italy.
Jorge FerreiraHospital de Santa Cruz, Lisbon, Portugal.
Xinhui RanTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
KyungAh ImTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
J Antonio G LópezAmgen, Thousand Oaks, California, USA.
Mary Elliott-DaveyAmgen, Thousand Oaks, California, USA.
Bei WangAmgen, Thousand Oaks, California, USA.
Maria Laura MonsalvoAmgen, Thousand Oaks, California, USA.
Dan AtarDepartment of Cardiology, Oslo University Hospital, Ulleval and University of Oslo, Institute of Clinical Medicine, Oslo, Norway.
Anthony KeechNational Health and Medical Research Council Clinical Trials Centre, Faculty of Health and Medical Sciences, University of Sydney, Sydney, New South Wales, Australia.
Robert P GiuglianoTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Marc S SabatineTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: msabatine@bwh.harvard.edu.
Brigham and Women's Hospital · USAmgen (United States) · USAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITHospital de Santa Cruz · PTOslo University Hospital · NOThe University of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), during a median follow-up of 2.2 years, risk reduction for major adverse cardiovascular event with evolocumab was greater in patients with multivessel disease (MVD). The FOURIER Open-Label Extension (FOURIER-OLE) provides an additional median follow-up of 5 years.

objectivesThe purpose of this study was to assess the long-term benefit of evolocumab in patients with and without MVD.

methodsFOURIER randomized 27,564 patients to evolocumab vs placebo; 6,635 entered FOURIER-OLE. Patients with coronary artery disease were categorized based on the presence of MVD (≥40% stenosis in ≥2 large vessels). The primary endpoint was cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; the key secondary endpoint was cardiovascular death, myocardial infarction, or stroke.

resultsOf 23,656 patients in FOURIER with coronary artery disease, 25.4% had MVD; 5,887 patients continued into FOURIER-OLE. The risk reduction with initial allocation to evolocumab tended to be greater in patients with MVD than in those without: 23% (HR: 0.77 [95% CI: 0.68-0.87]) vs 11% (HR: 0.89 [95% CI: 0.82-0.96]) for the primary and 31% (HR: 0.69 [95% CI: 0.59-0.81]) vs 15% (HR: 0.85 [95% CI: 0.77-0.94]) for the key secondary endpoints (P

conclusionsEvolocumab reduced the rate of major adverse cardiovascular event in patients with and without MVD. The benefit tended to occur earlier and was larger in patients with MVD. However, the magnitude grew over time in both groups. These data support early initiation of intensive low-density lipoprotein cholesterol lowering both in patients with and without MVD.

Indexed as

Antibodies, Monoclonal, HumanizedAnticholesteremic AgentsCoronary Artery DiseaseMyocardial InfarctionStrokeHumansPCSK9 InhibitorsProprotein Convertase 9Treatment OutcomeAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsevolocumabPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9coronary artery diseaseevolocumablow-density lipoprotein cholesterolmajor adverse cardiovascular eventsproprotein convertase subtilisin/kexin type 9 inhibitor

Identifiers

PMID38325990
OpenAlexW4391544470

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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.