Evidence map›Paper›PMID 31746218›Full record

ArticleClinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis

Improved Benefit Risk Profile of Rivaroxaban in a Subpopulation of the MAGELLAN Study.

Alex C Spyropoulos, Concetta Lipardi, Jianfeng Xu, Wentao Lu, Eunyoung Suh, Zhong Yuan, Bennett Levitan, Chiara Sugarmann, Yoriko De Sanctis, Theodore E Spiro and 2 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
10.5field-weighted citation impact, top 1% 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

37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.

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  7. La Tunisie medicale · 2025
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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

12 authors at 4 institutions in 1 country.

Alex C SpyropoulosThe Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.ORCID https://orcid.org/0000-0002-3175-461X
Concetta LipardiJanssen Research & Development, LLC, Raritan, NJ, USA.
Jianfeng XuJanssen Research & Development, LLC, Raritan, NJ, USA.
Wentao LuJanssen Research & Development, LLC, Raritan, NJ, USA.
Eunyoung SuhJanssen Research & Development, LLC, Raritan, NJ, USA.
Zhong YuanJanssen Research & Development, LLC, Raritan, NJ, USA.
Bennett LevitanJanssen Research & Development, LLC, Raritan, NJ, USA.
Chiara SugarmannJanssen Research & Development, LLC, Raritan, NJ, USA.ORCID https://orcid.org/0000-0003-2040-6983
Yoriko De SanctisClinical Development, Pharmaceuticals, Bayer U.S. LLC, Whippany, NJ, USA.
Theodore E SpiroClinical Development, Pharmaceuticals, Bayer U.S. LLC, Whippany, NJ, USA.
Elliot S BarnathanJanssen Research & Development, LLC, Raritan, NJ, USA.
Gary E RaskobCollege of Public Health, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Janssen (United States) · USBayer (United States) · USNorthwell Health · USUniversity of Oklahoma Health Sciences Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Acutely ill medical patients are at risk of venous thromboembolism (VTE) and VTE-related mortality during hospitalization and posthospital discharge, but widespread adoption of extended thromboprophylaxis has not occurred. We analyzed a subpopulation within the MAGELLAN study of extended thromboprophylaxis with rivaroxaban to reevaluate the benefit risk profile. We identified 5 risk factors for major and fatal bleeding after a clinical analysis of the MAGELLAN study and analyzed efficacy and safety with these patients excluded (n = 1551). Risk factors included: active cancer, dual antiplatelet therapy at baseline, bronchiectasis/pulmonary cavitation, gastroduodenal ulcer, or bleeding within 3 months before randomization. We evaluated efficacy, safety, and benefit risk using clinically comparable endpoints in the subpopulation. At day 10, rivaroxaban was noninferior to enoxaparin (relative risk [RR] = 0.82, 95% confidence interval [CI] = 0.58-1.15) and at day 35 rivaroxaban was significantly better than enoxaparin/placebo (RR = 0.68, 95% CI = 0.53-0.88) in reducing VTE and VTE-related death. Major bleeding was reduced at day 10 (RR = 2.18, 95% CI = 1.07-4.44 vs 1.19, 95% CI = 0.54-2.65) and at day 35 (2.87, 95% CI = 1.60-5.15 vs 1.48, 95% CI = 0.77-2.84) for MAGELLAN versus this subpopulation, respectively. The benefit risk profile was favorable in this subpopulation treated for 35 days, with the number needed to treat ranging from 55 to 481 and number needed to harm from 455 to 1067 for all pairwise evaluations. Five exclusionary criteria defined a subpopulation of acutely ill medical patients with a positive benefit risk profile for in-hospital and extended thromboprophylaxis with rivaroxaban.

Indexed as

Administration, OralAgedAnticoagulantsDouble-Blind MethodFactor Xa InhibitorsFemaleHumansMiddle AgedRisk FactorsRivaroxabanVenous ThromboembolismAnticoagulantsFactor Xa InhibitorsRivaroxabandirect oral anticoagulantshemorrhagemedical illnessrisk factorsthrombosis prophylaxisvenous thromboembolism

Identifiers

PMID31746218
PMCPMC7019408
OpenAlexW2990226564

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.