Evidence map›Paper›PMID 34495376›Full record

Trial reportDiabetologia2021

Rivaroxaban compared with low-dose aspirin in individuals with type 2 diabetes and high cardiovascular risk: a randomised trial to assess effects on endothelial function, platelet activation and vascular biomarkers.

Frank Pistrosch, Jan B Matschke, Dorothea Schipp, Bernhard Schipp, Elena Henkel, Ingo Weigmann, Jan Sradnick, Stefan R Bornstein, Andreas L Birkenfeld, Markolf Hanefeld

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

Trial report in Diabetologia, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02164578 (Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Low Dose Aspirin in Type-2 Diabetic Patients With Very High Cardiovascular Risk and Subclinical Inflammation), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.4field-weighted citation impact, top 10% 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.

NCT02164578 phase3completednot on this map

Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Low Dose Aspirin in Type-2 Diabetic Patients With Very High Cardiovascular Risk and Subclinical Inflammation

TypeinterventionalSponsorGWT-TUD GmbHRan2015 to 2020Enrolled179ConditionsType 2 Diabetic PatientsArmsRivaroxaban, Aspirin
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 19 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Impact of Dual Antithrombotic Therapy with Aspirin and Rivaroxaban on Secondary Cardiovascular Outcomes.Medical science monitor : international medical journal of experimental and clinical research · 2024
    Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. 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

10 authors at 5 institutions in 1 country.

Frank PistroschMedical Clinic III, Universitätsklinikum 'Carl Gustav Carus', Dresden, Germany. frank.pistrosch@uniklinikum-dresden.de.ORCID 0000-0001-8866-321X
Jan B MatschkeMedical Clinic III, Universitätsklinikum 'Carl Gustav Carus', Dresden, Germany.
Dorothea SchippIndependent Statistician, Rosenthal-Bielatal, Germany.
Bernhard SchippFaculty of Business and Economics, Department of Quantitative Methods, TU-Dresden, Dresden, Germany.
Elena HenkelGWT TU-Dresden GmbH, Dresden, Germany.
Ingo WeigmannMedical Clinic III, Universitätsklinikum 'Carl Gustav Carus', Dresden, Germany.
Jan SradnickMedical Clinic III, Universitätsklinikum 'Carl Gustav Carus', Dresden, Germany.
Stefan R BornsteinMedical Clinic III, Universitätsklinikum 'Carl Gustav Carus', Dresden, Germany.
Andreas L BirkenfeldInternal Medicine IV, Universitätsklinikum Tuebingen, Tuebingen, Germany.
Markolf HanefeldMedical Clinic III, Universitätsklinikum 'Carl Gustav Carus', Dresden, Germany.
University Hospital Carl Gustav Carus · DEGWT-TUD (Germany) · DEStatistisches Bundesamt · DETechnische Universität Dresden · DEUniversitätsklinikum Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisIndividuals with type 2 diabetes mellitus and subclinical inflammation have stimulated coagulation, activated platelets and endothelial dysfunction. Recent studies with the direct factor Xa inhibitor rivaroxaban in combination with low-dose aspirin demonstrated a significant reduction of major cardiovascular events, especially in individuals with type 2 diabetes and proven cardiovascular disease. Therefore, we asked the question of whether treatment with rivaroxaban could influence endothelial function, arterial stiffness and platelet activation.

methodsWe conducted a multi-centre, prospective, randomised, open-label trial in 179 participants with type 2 diabetes (duration 2-20 years), subclinical inflammation (high-sensitivity C-reactive protein 2-10 mg/l) and at least two traits of the metabolic syndrome to compare the effects of the direct factor Xa inhibitor rivaroxaban (5 mg twice daily) vs aspirin (100 mg every day) on endothelial function (assessed by forearm occlusion plethysmography), skin blood flow (assessed by laser-Doppler fluxmetry), arterial stiffness (assessed by pulse wave velocity) and serum biomarkers of endothelial function and inflammation. Furthermore, we investigated phosphorylation of vasodilator-stimulated phosphoprotein (VASP) in platelets, the concentration of platelet-derived microparticles (PMPs) and the effects of isolated PMPs on HUVEC proliferation in vitro.

resultsRivaroxaban treatment for 20 weeks (n = 89) resulted in a significant improvement of post-ischaemic forearm blood flow (3.6 ± 4.7 vs 1.0 ± 5.2 ml/100 ml, p = 0.004), a numerically increased skin blood flow and reduced soluble P-Selectin plasma level vs aspirin. We did not find significant differences of arterial stiffness or further biomarkers. Neither rivaroxaban nor aspirin influenced VASP phosphorylation of platelets. The number of PMPs increased significantly with both rivaroxaban (365.2 ± 372.1 vs 237.4 ± 157.1 μl CONCLUSIONS/

interpretationOur findings indicate that the direct factor Xa inhibitor rivaroxaban improved endothelial function in participants with type 2 diabetes and subclinical inflammation but also increased the risk of bleeding.

trial registrationClinicalTrials.gov NCT02164578.

fundingThe study was supported by a research grant from Bayer Vital AG, Germany.

Indexed as

Cardiovascular DiseasesCell-Derived MicroparticlesDiabetes Mellitus, Type 2AspirinBiomarkersDrug Therapy, CombinationHumansPlatelet ActivationPlatelet Aggregation InhibitorsProspective StudiesPulse Wave AnalysisRisk FactorsRivaroxabanAspirinBiomarkersPlatelet Aggregation InhibitorsRivaroxaban

Identifiers

PMID34495376
PMCPMC8563606
OpenAlexW3197892150

What OpenQuestion holds

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LicenceCC BY
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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.