Evidence map›Paper›PMID 31277561›Full record

Trial reportVascular medicine (London, England)2019

A randomized, placebo-controlled trial of canakinumab in patients with peripheral artery disease.

Kerry S Russell, Denise P Yates, Christopher M Kramer, Andrea Feller, Ping Mahling, Laurence Colin, Timothy Clough, Tianke Wang, Lucy LaPerna, Alpa Patel and 8 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Vascular medicine (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 7% 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.

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

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Peripheral artery disease in diabetes.Frontiers in endocrinology · 2026
    Review
  6. Implications of inflammation and sex in lower extremity arterial disease.European journal of clinical investigation · 2026
    Review
  7. Article
  8. Peripheral artery disease.Nature reviews. Disease primers · 2025
    Review
  9. Review
  10. Review
  11. Article
  12. Characteristics, Antithrombotic Patterns, and Prognostic Outcomes in Claudication and Critical Limb-Threatening Ischemia Undergoing Endovascular Therapy.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2024
    Observational
  13. Peripheral Artery Disease: Molecular Mechanisms and Novel Therapies.Arteriosclerosis, thrombosis, and vascular biology · 2024
    Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

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

5 · Who and what money

Authors and funding

18 authors at 9 institutions in 2 countries.

Kerry S RussellNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Denise P YatesNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Christopher M KramerUniversity of Virginia Health System, Charlottesville, VA, USA.ORCID 0000-0003-2057-7731
Andrea FellerNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Ping MahlingNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Laurence ColinNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Timothy CloughNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Tianke WangNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Lucy LaPernaRemington-Davis Clinical Research, Columbus, OH, USA.
Alpa PatelJacksonville Center for Clinical Research, Jacksonville, FL, USA.
Holger LawallPraxis für Herzkreislauferkrankungen, Max Grundig Klinik Bühlerhöhe, Bühl, Germany.
Mustafa M ShennakTriumpharma, Ammann, Jordan.
James FulmerRiver City Research, Jacksonville, FL, USA.
Sigrid NikolAsklepios Klinik Sankt Georg, Hamburg, Germany.
William B SmithUniversity of Tennessee, VRG/NOCCR, Knoxville, TN, USA.
Oliver J MüllerUniversity Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Elizabeth V RatchfordJohns Hopkins Medicine, Baltimore, MD, USA.
Craig T BassonNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Novartis (United States) · USAsklepios Klinik St. Georg · DEBühler (Germany) · DEJacksonville Center for Clinical Research · USJohns Hopkins University · USRemington-Davis Clinical Research · USUniversity Hospital Schleswig-Holstein · DEUniversity of Tennessee at Knoxville · USUniversity of Virginia Health System · US

Funding

Comprehensive Magnetic Resonance in PADR01HL075792 · NHLBI · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI KRAMER, CHRISTOPHER M. · 2003 to 2021
$10.5M
NHLBI NIH HHS R01 HL075792
6 · The paper itself

Abstract

Extensive atherosclerotic plaque burden in the lower extremities often leads to symptomatic peripheral artery disease (PAD) including impaired walking performance and claudication. Interleukin-1β (IL-1β) may play an important pro-inflammatory role in the pathogenesis of this disease. Interruption of IL-1β signaling was hypothesized to decrease plaque progression in the leg macrovasculature and improve the mobility of patients with PAD with intermittent claudication. Thirty-eight patients (mean age 65 years; 71% male) with symptomatic PAD (confirmed by ankle-brachial index) were randomized 1:1 to receive canakinumab (150 mg subcutaneously) or placebo monthly for up to 12 months. The mean vessel wall area (by 3.0 T black-blood magnetic resonance imaging (MRI)) of the superficial femoral artery (SFA) was used to measure plaque volume. Mobility was assessed using the 6-minute walk test. Canakinumab was safe and well tolerated. Markers of systemic inflammation (interleukin-6 and high-sensitivity C-reactive protein) fell as early as 1 month after treatment. MRI (32 patients at 3 months; 21 patients at 12 months) showed no evidence of plaque progression in the SFA in either placebo-treated or canakinumab-treated patients. Although an exploratory endpoint, placebo-adjusted maximum and pain-free walking distance (58 m) improved as early as 3 months after treatment with canakinumab when compared with placebo. Although canakinumab did not alter plaque progression in the SFA, there is an early signal that it may improve maximum and pain-free walking distance in patients with symptomatic PAD. Larger studies aimed at this endpoint will be required to definitively demonstrate this.

Indexed as

AgedAntibodies, Monoclonal, HumanizedAnti-Inflammatory AgentsBiomarkersDouble-Blind MethodExercise ToleranceFemaleGermanyHumansInflammation MediatorsIntermittent ClaudicationJordanMaleMiddle AgedPeripheral Arterial DiseaseProof of Concept StudyAntibodies, Monoclonal, HumanizedAnti-Inflammatory AgentsBiomarkerscanakinumabInflammation Mediatorscanakinumabinterleukin-1βintermittent claudicationperipheral artery disease (PAD)

Identifiers

PMID31277561
PMCPMC6791746
OpenAlexW2954442235

What OpenQuestion holds

Textmetadata
LicenceTDM
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 OpenQuestion graph.