Evidence map›Paper›PMID 39188889›Full record

ArticleResearch and practice in thrombosis and haemostasis2024

Exploratory rivaroxaban trial for isolated calf deep vein thrombosis with a risk factor of thrombosis extension: an open-label, multicenter, randomized controlled trial.

Yoshito Ogihara, Norikazu Yamada, Daisuke Izumi, Yuichi Sato, Toru Sato, Hitoshi Nakaya, Tatsuya Mori, Satoshi Ota, Midori Makino, Toru Ogura and 7 more

Abstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. 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

17 authors.

Yoshito OgiharaDepartment of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan.
Norikazu YamadaDepartment of Cardiology, Kuwana City Medical Center, Kuwana, Japan.
Daisuke IzumiDepartment of Cardiology, Matsusaka Municipal Hospital, Matsusaka, Japan.
Yuichi SatoDepartment of Cardiology, Matsusaka Chuo General Hospital, Matsusaka, Japan.
Toru SatoDepartment of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan.
Hitoshi NakayaDepartment of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan.
Tatsuya MoriDepartment of Cardiology, Ise Red Cross Hospital, Ise, Japan.
Satoshi OtaDepartment of Cardiology, Suzuka General Hospital, Suzuka, Japan.
Midori MakinoDepartment of Cardiology, Suzuka General Hospital, Suzuka, Japan.
Toru OguraClinical Research Support Center, Mie University Hospital, Tsu, Japan.
Satoshi TamaruClinical Research Support Center, Mie University Hospital, Tsu, Japan.
Yuki NishimuraClinical Research Support Center, Mie University Hospital, Tsu, Japan.
Takashi TanigawaDepartment of Cardiology, Matsusaka Chuo General Hospital, Matsusaka, Japan.
Atsunobu KasaiDepartment of Cardiology, Ise Red Cross Hospital, Ise, Japan.
Masakatsu NishikawaClinical Research Support Center, Mie University Hospital, Tsu, Japan.
Kaoru DohiDepartment of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan.
ISE CALF DVT Study Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Limited evidence exists regarding the incidence of recurrent venous thromboembolism (VTE) in patients diagnosed with isolated distal deep vein thrombosis (DVT) who are at risk of thrombosis extension whether they receive anticoagulation therapy or not. Objectives: The study aimed to investigate the incidence of recurrent VTE and the impact of rivaroxaban in this patient population. Methods: This open-label, exploratory, and randomized controlled trial was conducted at 7 centers in Japan between April 2019 and April 2022. Adult patients with isolated distal DVT at risk of thrombosis extension received either rivaroxaban combined with physical therapy or physical therapy alone for 90 days. Whole-leg ultrasound was performed at 14 and 90 days. We assessed a composite outcome of symptomatic or asymptomatic proximal DVT or symptomatic pulmonary embolism as the primary outcome until the end of the treatment period using an intention-to-treat analysis. Major bleeding was evaluated as a key secondary outcome. Results: Out of 90 enrolled patients, 3 were excluded due to withdrawal of consent; therefore, we analyzed 87 participants. The rivaroxaban group ( Conclusion: Preliminary data suggest that rivaroxaban may reduce the risk of VTE recurrence among this patient subset, albeit with an increased incidence of bleeding events.

Indexed as

anticoagulantsrandomized controlled trialrecurrencerivaroxabanvein thrombosis

Identifiers

PMID39188889
PMCPMC11347048

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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.