Evidence map›Paper›PMID 29552984›Full record

Trial reportJournal of endovascular therapy : an official journal of the International Society of Endovascular Specialists2018

Edoxaban Plus Aspirin vs Dual Antiplatelet Therapy in Endovascular Treatment of Patients With Peripheral Artery Disease: Results of the ePAD Trial.

Frans Moll, Iris Baumgartner, Michael Jaff, Chuke Nwachuku, Marco Tangelder, Gary Ansel, George Adams, Thomas Zeller, John Rundback, Michael Grosso and 4 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01802775 (A Randomized, Open-Label, Parallel-Group, Multi-Center Study Of Adding Edoxaban Or Clopidogrel To Aspirin To Maintain Patency In Subjects With Peripheral Arterial Disease Following Femoropopliteal Endovascular Intervention), which is not on this map. Cited by 31 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 5 pooled it
12.1field-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.

NCT01802775 phase2completednot on this map

A Randomized, Open-Label, Parallel-Group, Multi-Center Study Of Adding Edoxaban Or Clopidogrel To Aspirin To Maintain Patency In Subjects With Peripheral Arterial Disease Following Femoropopliteal Endovascular Intervention

TypeinterventionalSponsorDaiichi SankyoRan2013 to 2014Enrolled203ConditionsPeripheral Arterial DiseaseArmsedoxaban, Clopidogrel, Aspirin
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 5 syntheses or guidelines pooled it, 96 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  5. Pooled it
  6. Enrollment of Historically Underrepresented Groups in Peripheral Arterial Disease Trials: A Systematic Review.Journal of the Society for Cardiovascular Angiography & Interventions · 2026
    Review
  7. Review
  8. Medical Therapy for Peripheral Artery Disease.Current cardiology reports · 2024
    Review
  9. Observational
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Antithrombotic therapy in peripheral arterial disease.Frontiers in cardiovascular medicine · 2022
    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

14 authors at 9 institutions in 5 countries.

Frans Moll1 Department of Vascular Surgery, University Medical Center Utrecht, the Netherlands.
Iris Baumgartner2 Cardiovascular Research Cluster, Universität Bern, Switzerland.
Michael Jaff3 Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA.
Chuke Nwachuku4 Daiichi Sankyo Pharma Development, Edison, NJ, USA.
Marco Tangelder1 Department of Vascular Surgery, University Medical Center Utrecht, the Netherlands.
Gary Ansel5 Vascular Services, Ohio Health Heart & Vascular Physicians, Columbus, OH, USA.
George Adams6 Cardiovascular and Peripheral Vascular Research, Rex Hospital University of North Carolina Health System, Raleigh, NC, USA.
Thomas Zeller7 Department of Angiology, Universitäts Herzzentrum, Bad Krozingen, Germany.
John Rundback8 Interventional Institute, Holy Name Medical Center, Teaneck, NJ, USA.
Michael Grosso4 Daiichi Sankyo Pharma Development, Edison, NJ, USA.
Min Lin4 Daiichi Sankyo Pharma Development, Edison, NJ, USA.
Michele F Mercur4 Daiichi Sankyo Pharma Development, Edison, NJ, USA.
Erich Minar9 Internal Medicine, Medical University Vienna, Austria.
ePAD Investigators
Daiichi Sankyo (United States) · USUniversity Medical Center Utrecht · NLHarvard University · USHoly Name Medical Center · USMedical University of Vienna · ATOhioHealth · USRex Hospital · USUniversitäts-Herzzentrum Freiburg-Bad Krozingen · DEUniversity of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo report a randomized study that investigated the safety (risk of major bleeds) and potential efficacy of edoxaban, an oral anticoagulant that targets the major components of arterial thrombi, to prevent loss of patency following endovascular treatment (EVT).

methodsBetween February 2012 and June 2014, 203 patients who underwent femoropopliteal EVT were randomized to receive aspirin plus edoxaban or aspirin plus clopidogrel for 3 months in the Edoxaban in Peripheral Arterial Disease (ePAD) study ( ClinicalTrials.gov identifier NCT01802775). Randomization assigned 101 patients (mean age 68.0±10.4 years; 67 men) to the edoxaban group and 102 patients (mean age 66.7±8.6 years; 78 men) to the clopidogrel group. The primary safety endpoint was bleeding as classified by the TIMI (Thrombolysis in Myocardial Infarction) criteria and ISTH (International Society of Thrombosis and Hemostasis) criteria; the efficacy endpoint was the rate of restenosis/reocclusion.

resultsThere were no major or life-threatening bleeding events in the edoxaban group, while there were 2 major and 2 life-threatening bleeding events in the clopidogrel group by the TIMI criteria. By the ISTH classification, there was 1 major and 1 life-threatening bleeding event vs 5 major and 2 life-threatening bleeding events, respectively [relative risk (RR) 0.20, 95% confidence interval (CI) 0.02 to 1.70]. The bleeding risk was not statistically different with either treatment when assessed by TIMI or ISTH. Following 6 months of observation, there was a lower incidence of restenosis/reocclusion with edoxaban compared with clopidogrel (30.9% vs 34.7%; RR 0.89, 95% CI 0.59 to 1.34, p=0.643).

conclusionThese results suggest that patients who have undergone EVT have similar risks for major and life-threatening bleeding events with edoxaban and aspirin compared with clopidogrel and aspirin. The incidence of restenosis/reocclusion events, while not statistically different, was lower with edoxaban and aspirin, but an adequately sized trial will be needed to confirm these findings.

Indexed as

Endovascular ProceduresAgedAspirinClopidogrelDrug Therapy, CombinationEuropeFactor Xa InhibitorsFemaleFibrinolytic AgentsHemorrhageHumansIsraelLower ExtremityMaleMiddle AgedPeripheral Arterial DiseaseAspirinClopidogreledoxabanFactor Xa InhibitorsFibrinolytic AgentsPlatelet Aggregation InhibitorsPyridinesThiazolesantiplatelet therapyaspirinbleedingclopidogreledoxabanendovascular treatmentfemoropopliteal segmentpatencyperipheral artery diseasereocclusionrestenosis

Identifiers

PMID29552984
PMCPMC5862321
OpenAlexW2790180402

What OpenQuestion holds

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LicenceCC BY-NC
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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.