Evidence map›Paper›PMID 37227726›Full record

Trial reportJAMA network open2023

Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial.

Dino Kröll, Philipp C Nett, Nikki Rommers, Yves Borbély, Fabian Deichsel, Antonio Nocito, Jörg Zehetner, Ulf Kessler, Yannick Fringeli, Lorenzo Alberio and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in JAMA network open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03522259 (BARIVA), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–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.

NCT03522259 phase2completednot on this map

BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2018 to 2023Enrolled272ConditionsBariatric SurgeryArmsRivaroxaban 10 MG Oral Tablet [Xarelto]
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  12. Observational
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  15. Review
  16. Article
  17. Challenges in the care and treatment of patients with extreme obesity.Archives of endocrinology and metabolism · 2024
    Review
  18. 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

12 authors.

Dino KröllDepartment of Visceral Surgery and Medicine, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Philipp C NettDepartment of Visceral Surgery and Medicine, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Nikki RommersDepartment of Clinical Research, Clinical Trial Unit, University of Basel, Switzerland.
Yves BorbélyDepartment of Visceral Surgery and Medicine, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Fabian DeichselDepartment of Surgery, Cantonal Hospital of Baden, Baden, Switzerland.
Antonio NocitoDepartment of Surgery, Cantonal Hospital of Baden, Baden, Switzerland.
Jörg ZehetnerDepartment of Visceral Surgery, Hirslanden Clinic Beau-Site, Bern, Switzerland.
Ulf KesslerDepartment of Visceral Surgery, Hirslanden Clinic Beau-Site, Bern, Switzerland.
Yannick FringeliDepartment of Visceral Surgery, Hirslanden Clinic Beau-Site, Bern, Switzerland.
Lorenzo AlberioDivision of Haematology and Central Haematology Laboratory, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.
Daniel CandinasDepartment of Visceral Surgery and Medicine, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Guido StirnimannDepartment of Visceral Surgery and Medicine, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Venous thromboembolism (VTE) is a leading cause of morbidity and mortality after bariatric surgery. Clinical end point studies on thromboprophylaxis with direct oral anticoagulants in patients undergoing bariatric surgery are lacking. Objective: To assess the efficacy and safety of a prophylactic dose of 10 mg/d of rivaroxaban for both 7 and 28 days after bariatric surgery. Design, Setting, and Participants: This assessor-blinded, phase 2, multicenter randomized clinical trial was conducted from July 1, 2018, through June 30, 2021, with participants from 3 academic and nonacademic hospitals in Switzerland. Intervention: Patients were randomized 1 day after bariatric surgery to 10 mg of oral rivaroxaban for either 7 days (short prophylaxis) or 28 days (long prophylaxis). Main Outcomes and Measures: The primary efficacy outcome was the composite of deep vein thrombosis (symptomatic or asymptomatic) and pulmonary embolism within 28 days after bariatric surgery. Main safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and mortality. Results: Of 300 patients, 272 (mean [SD] age, 40.0 [12.1] years; 216 women [80.3%]; mean body mass index, 42.2) were randomized; 134 received a 7-day and 135 a 28-day VTE prophylaxis course with rivaroxaban. Only 1 thromboembolic event (0.4%) occurred (asymptomatic thrombosis in a patient undergoing sleeve gastrectomy with extended prophylaxis). Major or clinically relevant nonmajor bleeding events were observed in 5 patients (1.9%): 2 in the short prophylaxis group and 3 in the long prophylaxis group. Clinically nonsignificant bleeding events were observed in 10 patients (3.7%): 3 in the short prophylaxis arm and 7 in the long prophylaxis arm. Conclusions and Relevance: In this randomized clinical trial, once-daily VTE prophylaxis with 10 mg of rivaroxaban was effective and safe in the early postoperative phase after bariatric surgery in both the short and long prophylaxis groups. Trial Registration: ClinicalTrials.gov Identifier: NCT03522259.

Indexed as

Pulmonary EmbolismVenous ThromboembolismAdultAnticoagulantsFemaleHemorrhageHumansPostoperative ComplicationsRivaroxabanAnticoagulantsRivaroxaban

Identifiers

PMID37227726
PMCPMC10214035

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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.