Evidence map›Paper›PMID 26580706›Full record

Trial reportBritish journal of clinical pharmacology2016

Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co-medication interactions.

Reinhold Kreutz, Sylvia Haas, Gerlind Holberg, Michael R Lassen, Lorenzo G Mantovani, André Schmidt, Alexander G G Turpie

Open access · hybridAbstract readClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.2field-weighted citation impact, top 12% 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

7 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. The role of new oral anticoagulants in orthopaedics: an update of recent evidence.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2017
    Review
  7. Article
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

7 authors at 7 institutions in 5 countries.

Reinhold KreutzInstitute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin, Berlin, Germany.
Sylvia HaasInstitute for Experimental Oncology and Therapy Research, Technical University of Munich, Munich, Germany.
Gerlind HolbergBayer HealthCare AG, Berlin, Germany.
Michael R LassenGlostrup Hospital, University of Copenhagen, Glostrup, Denmark.
Lorenzo G MantovaniCESP-Center for Public Health Research, University of Milan-Bicocca, Monza, Italy.
André SchmidtBayer HealthCare AG, Berlin, Germany.
Alexander G G TurpieDepartment of Medicine, Hamilton Health Services, Hamilton, Ontario, Canada.
Bayer (Germany) · DEBayer (United States) · USCharité - Universitätsmedizin Berlin · DEHamilton Health Sciences · CATechnical University of Munich · DEUniversity of Copenhagen · DKUniversity of Milano-Bicocca · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe aim of the present study was to analyse concomitant drug use and its association with outcome in patients (N = 17 701) receiving rivaroxaban or standard of care (SOC) for the prevention of venous thromboembolism after major orthopaedic surgery in the non-interventional, phase IV XAMOS (Xarelto® in the prophylaxis of post-surgical venous thromboembolism after elective major orthopaedic surgery of hip or knee) study.

methodsConcomitant drug use was at the discretion of the treating physician. Prespecified co-medications of interest were cytochrome P450 (CYP) 3A4/P-glycoprotein inhibitors/inducers, platelet aggregation inhibitors (PAIs) and nonsteroidal anti-inflammatory drugs (NSAIDs). Crude event incidences were compared between rivaroxaban and SOC groups.

resultsCYP3A4/P-glycoprotein inhibitor/inducer use was infrequent, in contrast to PAI (~7%) and NSAID (~52%) use. Rivaroxaban was associated with a lower incidence of overall symptomatic thromboembolic events compared with SOC, regardless of co-medication use. In both treatment groups, PAI users, with higher age and prevalence of cardiovascular co-morbidities, had similar higher (>7-fold) incidences of symptomatic arterial but not venous thromboembolic events compared with non-users. NSAID use had no influence on thromboembolic events. However, odds ratios (ORs) for major bleeding events (European Medicines Agency definition) were higher in NSAID users compared with non-users in rivaroxaban [OR = 1.50; 95% confidence interval (CI) 1.06, 2.13] and SOC (OR = 1.70; CI 1.16, 2.49) groups. In PAI users, ORs for major bleeding events were no different from those of non-users in both the rivaroxaban (OR = 1.49; CI 0.84, 2.65) and SOC (OR = 1.46; CI 0.82, 2.62) groups.

conclusionsUse of NSAIDs in XAMOS was frequent and associated with a higher frequency of bleeding events in patients receiving rivaroxaban or SOC, although the benefit-risk profile of rivaroxaban compared with SOC was maintained.

Indexed as

AgedAnticoagulantsArthroplasty, Replacement, HipArthroplasty, Replacement, KneeCohort StudiesDrug InteractionsFemaleHemorrhageHumansMaleMiddle AgedRivaroxabanVenous ThromboembolismAnticoagulantsRivaroxabanbleedingmajor orthopaedic surgerynonsteroidal anti-inflammatory drugplatelet aggregation inhibitorrivaroxabanvenous thromboembolism

Identifiers

PMID26580706
PMCPMC4799939
OpenAlexW2181124388

What OpenQuestion holds

Textmetadata
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.