Evidence map›Paper›PMID 32586587›Full record

Trial reportJournal of the American College of Cardiology2020

Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.

Alex C Spyropoulos, Walter Ageno, Gregory W Albers, C Gregory Elliott, Jonathan L Halperin, William R Hiatt, Gregory A Maynard, P Gabriel Steg, Jeffrey I Weitz, Wentao Lu and 3 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American College of Cardiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02111564 (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk), which is not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
6.8field-weighted citation impact, top 2% 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.

NCT02111564 phase3completednot on this map

Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2018Enrolled12,024ConditionsHeart Failure, Respiratory Insufficiency, Stroke Acute, Infectious DiseasesArmsRivaroxaban, 10 mg, Rivaroxaban, 7.5 mg, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.

  1. Pooled it
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  8. Immunity and Coagulation in COVID-19.International journal of molecular sciences · 2024
    Review
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  13. Review
  14. Therapeutic advances in COVID-19.Nature reviews. Nephrology · 2023
    Review
  15. Review
  16. ISTH guidelines for antithrombotic treatment in COVID-19.Journal of thrombosis and haemostasis : JTH · 2022
    Article
  17. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 12 institutions in 5 countries.

Alex C SpyropoulosThe Donald and Barbara Zucker School of Medicine and Hofstra/Northwell, The Feinstein Institute for Medical Research, and Department of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital, New York, New York. Electronic address: aspyropoul@northwell.edu.
Walter AgenoDepartment of Medicine and Surgery, University of Insubria, Varese, Italy.
Gregory W AlbersStanford Stroke Center, Stanford University Medical Center, Stanford, California.
C Gregory ElliottDepartment of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City, Utah.
Jonathan L HalperinThe Cardiovascular Institute, Mount Sinai Medical Center, New York, New York.
William R HiattUniversity of Colorado School of Medicine, Division of Cardiology, Aurora, Colorado; CPC Clinical Research, Aurora, Colorado.
Gregory A MaynardUniversity of California, Davis, Sacramento, California.
P Gabriel StegUniversité de Paris, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, Paris, France; Imperial College, Royal Brompton Hospital, London, United Kingdom.
Jeffrey I WeitzMcMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada.
Wentao LuJanssen Research & Development, LLC, Raritan, New Jersey.
Theodore E SpiroThrombosis and Hematology Therapeutic Area, Clinical Development, Pharmaceuticals, Bayer U.S. LLC, Whippany, New Jersey.
Elliot S BarnathanJanssen Research & Development, LLC, Raritan, New Jersey.
Gary E RaskobHudson College of Public Health, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.
Janssen (United States) · USBayer (United States) · USFeinstein Institute for Medical Research · USIntermountain Medical Center · USMcMaster University · CAMount Sinai Medical Center · USStanford Medicine · USUniversité Paris Cité · FRUniversity of California, Davis · USUniversity of Colorado Denver · USUniversity of Insubria · ITUniversity of Oklahoma Health Sciences Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHospitalized acutely ill medical patients are at risk for fatal and major thromboembolic events. Whether use of extended-duration primary thromboprophylaxis can prevent such events is unknown.

objectivesThe purpose of this study was to evaluate whether extended-duration rivaroxaban reduces the risk of venous and arterial fatal and major thromboembolic events without significantly increasing major bleeding in acutely ill medical patients after discharge.

methodsMARINER (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients) studied acutely ill medical patients with additional risk factors for venous thromboembolism (VTE). Medically ill patients with a baseline creatinine clearance ≥50 ml/min were randomized in a double-blind fashion to rivaroxaban 10 mg or placebo daily at hospital discharge for 45 days. Exploratory efficacy analyses were performed with the intent-to-treat population including all data through day 45. Time-to-event curves were calculated using the Kaplan-Meier method. A blinded independent committee adjudicated all clinical events.

resultsIn total, 4,909 patients were assigned to rivaroxaban and 4,913 patients to placebo. The mean age was 67.8 years, 55.5% were men, mean baseline creatinine clearance was 87.8 ml/min, and mean duration of hospitalization was 6.7 days. The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398).

conclusionsExtended-duration rivaroxaban in hospitalized medically ill patients resulted in a 28% reduction in fatal and major thromboembolic events without a significant increase in major bleeding. (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients [MARINER]; NCT02111564).

Indexed as

ChemopreventionHemorrhagePatient DischargeRivaroxabanVenous ThromboembolismAcute DiseaseAftercareAgedDouble-Blind MethodFactor Xa InhibitorsFemaleHospitalizationHumansMaleMiddle AgedTreatment OutcomeFactor Xa InhibitorsRivaroxabanhospitalizedmajor bleedingmedically illrivaroxabanthromboembolic events

Identifiers

PMID32586587
PMCPMC7308003
OpenAlexW3036947290

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.