Evidence map›Paper›PMID 38650055›Full record

Trial reportEuropean heart journal. Cardiovascular pharmacotherapy2024

Edoxaban for 12 vs. 3 months in cancer-associated isolated distal deep vein thrombosis according to different doses: insights from the ONCO DVT study.

Ryuki Chatani, Yugo Yamashita, Takeshi Morimoto, Nao Muraoka, Michihisa Umetsu, Yuji Nishimoto, Takuma Takada, Yoshito Ogihara, Tatsuya Nishikawa, Nobutaka Ikeda and 15 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in European heart journal. Cardiovascular pharmacotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03895502 (Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 6% 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.

NCT03895502 phase4completednot on this map

Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study

TypeinterventionalSponsorTakeshi MorimotoRan2019 to 2023Enrolled605ConditionsVenous Thrombosis, Neoplasms, AnticoagulantArms12-month Edoxaban, 3-month Edoxaban
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
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

25 authors at 20 institutions in 1 country.

Ryuki ChataniDepartment of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki 7100052, Japan.ORCID 0009-0009-7622-8494
Yugo YamashitaDepartment of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, 6068507 Kyoto, Japan.ORCID 0000-0003-2583-1321
Takeshi MorimotoDepartment of Clinical Epidemiology, Hyogo Medical University, Nishinomiya 6638501, Japan.ORCID 0000-0002-6844-739X
Nao MuraokaDivision of Cardiology, Shizuoka Cancer Center, Shizuoka 4118777, Japan.
Michihisa UmetsuDivision of Vascular Surgery, Department of Surgery, Tohoku University Hospital, Sendai 9808574, Japan.
Yuji NishimotoDivision of Cardiology, Osaka General Medical Center, Osaka 5588558, Japan.
Takuma TakadaDepartment of Cardiology, Tokyo Women's Medical University, Tokyo 1628666, Japan.ORCID 0000-0002-9172-0163
Yoshito OgiharaDepartment of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu 5148507, Japan.
Tatsuya NishikawaDepartment of Onco-Cardiology, Osaka International Cancer Institute, Osaka 5418567, Japan.
Nobutaka IkedaDivision of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo 1538515, Japan.ORCID 0000-0002-1615-3736
Kazunori OtsuiDepartment of General Internal Medicine, Kobe University Graduate School of Medicine, Kobe 6500017, Japan.
Daisuke SuetaDepartment of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto 8608556, Japan.ORCID 0000-0003-0960-0339
Yukari TsubataDepartment of Internal Medicine, Division of Medical Oncology and Respiratory Medicine, Shimane University Faculty of Medicine, Izumo 6938501, Japan.
Masaaki ShojiDepartment of Cardiovascular Medicine, National Cancer Center Hospital, Tokyo 1040045, Japan.
Ayumi ShikamaDepartment of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba 3058576, Japan.
Yutaka HosoiDepartment of Cardiovascular Surgery, Kyorin University Faculty of Medicine, Tokyo 1818611, Japan.
Yasuhiro TanabeDepartment of Cardiology, St Marianna University School of Medicine, Kawasaki 2168511, Japan.ORCID 0000-0001-8580-9404
Kengo TsukaharaDivision of Cardiology, Fujisawa City Hospital, Fujisawa 2518550, Japan.
Naohiko NakanishiDepartment of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 6028566, Japan.
Kitae KimDepartment of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe 6500047, Japan.ORCID 0000-0001-5751-5775
Satoshi IkedaDepartment of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 8528501, Japan.ORCID 0000-0001-8163-8038
Kazunori MushiakeDepartment of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki 7100052, Japan.
Kazushige KadotaDepartment of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki 7100052, Japan.ORCID 0000-0003-2845-9561
Koh OnoDepartment of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, 6068507 Kyoto, Japan.ORCID 0000-0002-4163-980X
Takeshi KimuraDepartment of Cardiology, Hirakata Kohsai Hospital, Hirakata 5730153, Japan.ORCID 0000-0002-5665-4076
Kurashiki Central Hospital · JPKyoto University · JPFujisawa City Hospital · JPHyogo University · JPKobe City Medical Center General Hospital · JPKobe University · JPKumamoto University · JPKyorin University · JPKyoto Prefectural University of Medicine · JPMie University · JPMunicipal Hirakata City Hospital · JPNagasaki University · JPOsaka International Cancer Institute · JPOsaka Prefectural Medical Center · JPShimane University · JPShizuoka Cancer Center · JPSt. Marianna University School of Medicine · JPTohoku University Hospital · JPToho University · JPTokyo National Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe ONCO DVT study revealed the superiority of 12-month relative to 3-month edoxaban treatment for cancer-associated isolated distal deep vein thrombosis (DVT) regarding the thrombotic risk. METHODS AND

resultsIn this pre-specified subgroup analysis of the ONCO DVT study, we stratified the patients into those with a standard edoxaban dose (60 mg/day; N = 151) and those with a reduced edoxaban dose (30 mg/day; N = 450) and evaluated the clinical outcomes for the 12- and 3-month treatments. The cumulative 12-month incidence of symptomatic recurrent venous thromboembolism was lower in the 12-month than 3-month group for both the 60 mg (1.3% vs. 11.6%, P = 0.02; odds ratio [OR], 0.12; 95% confidence interval [CI], 0.01-0.97) and 30 mg (1.1% vs. 7.6%, P = 0.002; OR, 0.14; 95% CI, 0.03-0.60) edoxaban subgroups, which was consistent across the edoxaban doses without a significant interaction (P = 0.90). The 12-month cumulative incidence of major bleeding was higher in the 12-month group than in the 3-month group for the 60 mg edoxaban subgroup (14.3% vs. 4.4%, P = 0.046; OR, 3.61; 95% CI, 0.97-13.52), whereas it did not significantly differ between the two groups for the 30 mg edoxaban subgroup (8.7% vs. 8.6%, P = 0.89; OR, 0.97; 95% CI, 0.49-1.91), signalling there was a potential interaction (P = 0.07).

conclusionsA 12-month edoxaban regimen for cancer-associated isolated distal DVT was consistently superior to a 3-month regimen, across the edoxaban doses for the thrombotic risk. However, caution was suggested for the standard dose of edoxaban due to the potential for an increased risk of bleeding with prolonged anticoagulation therapy. TRIAL REGISTRATION NUMBER: NCT03895502 (ONCO DVT Trial): https://classic.clinicaltrials.gov/ct2/show/NCT03895502.

Indexed as

Factor Xa InhibitorsNeoplasmsPyridinesThiazolesVenous ThrombosisAgedDouble-Blind MethodDrug Administration ScheduleFemaleHemorrhageHumansIncidenceMaleMiddle AgedRecurrenceRisk FactorsedoxabanFactor Xa InhibitorsPyridinesThiazolesAnticoagulant regimenCancerCardio-oncologyDeep vein thrombosisEdoxaban

Identifiers

PMID38650055
PMCPMC11323369
OpenAlexW4395051328

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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.