Evidence map›Paper›PMID 34314574›Full record

Trial reportJournal of thrombosis and haemostasis : JTH2021

Rivaroxaban for extended thromboprophylaxis in acutely ill medical patients 75 years of age or older.

Walter Ageno, Renato D Lopes, Mark Goldin, Roger D Yusen, Gregory W Albers, Gregory C Elliott, Jonathan L Halperin, William R Hiatt, Gregory Maynard, Philippe Gabriel Steg and 6 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of thrombosis and haemostasis : JTH, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 24% 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.

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

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
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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

16 authors at 13 institutions in 5 countries.

Walter AgenoDepartment of Medicine and Surgery, University of Insubria, Varese, Italy.
Renato D LopesDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Mark GoldinDepartment of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital, The Feinstein Institute for Medical Research and Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA.
Roger D YusenDivision of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Gregory W AlbersDirector Stanford Stroke Center, Stanford Medical Center, Stanford University, Palo Alto, CA, USA.
Gregory C ElliottDepartments of Medicine, University of Utah and Intermountain Healthcare, Salt Lake City, UT, USA.
Jonathan L HalperinCardiovascular Institute, Mount Sinai Medical Center, New York, NY, USA.
William R HiattDivision of Cardiology, University of Colorado School of Medicine, and CPC Clinical Research, Aurora, CO, USA.
Gregory MaynardUniversity of California at Davis, Sacramento, CA, USA.
Philippe Gabriel StegUniversité de Paris, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, Paris, France.
Jeffrey I WeitzMcMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada.ORCID 0000-0002-1092-7550
Eunyoung SuhCardiovascular Clinical Development, Janssen Research and Development, LLC, Raritan, NJ, USA.
Wentao LuCardiovascular Clinical Development, Janssen Research and Development, LLC, Raritan, NJ, USA.
Elliot S BarnathanCardiovascular Clinical Development, Janssen Research and Development, LLC, Raritan, NJ, USA.
Gary E RaskobHudson College of Public Health, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Alex C SpyropoulosDepartment of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital, The Feinstein Institute for Medical Research and Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA.
Janssen (United States) · USNorthwell Health · USDuke University · USInserm · FRIntermountain Healthcare · USMount Sinai Medical Center · USStanford University · USThrombosis and Atherosclerosis Research Institute · CAUniversity of California, Davis · USUniversity of Colorado Denver · USUniversity of Insubria · ITUniversity of Oklahoma Health Sciences Center · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough older patients are at increased risk for venous thromboembolism (VTE), thromboprophylaxis is underused because of bleeding concerns. The MARINER trial evaluated whether rivaroxaban reduced symptomatic postdischarge VTE in acutely ill medical patients.

objectivesWe hypothesized that rivaroxaban would have a favorable benefit/risk profile in patients ≥75 years of age.

methodsPatients were randomized in a double-blind manner at hospital discharge to rivaroxaban (10 mg/day for creatinine clearance ≥50 ml/min; 7.5 mg/day for ≥30-<50 ml/min) or placebo for 45 days. Using a Cox proportional hazard model including treatment as a covariate, we compared the risk of the primary efficacy outcome (symptomatic VTE plus VTE-related death in the intention-to-treat population) and safety outcome (International Society on Thrombosis and Haemostasis major bleeding in the safety population) in the prespecified subgroups of patients ≥ and <75 years of age.

resultsThe primary event rate in patients ≥75 years of age was 2-fold higher than that in those <75 years. The incidence of the primary efficacy outcomes in both age groups was numerically lower with rivaroxaban than with placebo (≥75: 1.2% and 1.6%, HR 0.73, 95% CI 0.43-1.22; <75 0.6% and 0.8%, HR 0.78, 95% CI 0.46-1.32; interaction p-value for age group = .85). The incidence of major bleeding was low and similar in the two age and treatment groups (interaction p value for age group = .35).

conclusionSymptomatic VTE and VTE-related death occur frequently in older patients with acute medical illness. The benefit/risk profile of rivaroxaban in patients ≥75 years of age appears consistent with that observed in the general population.

Indexed as

RivaroxabanVenous ThromboembolismAftercareAgedAnticoagulantsHumansPatient DischargeRisk FactorsTreatment OutcomeAnticoagulantsRivaroxabananticoagulation agentselderlyrisk assessmentrivaroxabanvenous thromboembolism

Identifiers

PMID34314574
PMCPMC9292378
OpenAlexW3186149284

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.