Evidence map›Paper›PMID 25925992›Full record

Trial reportThrombosis and haemostasis2015

Peri-procedural use of rivaroxaban in elective percutaneous coronary intervention to treat stable coronary artery disease. The X-PLORER trial.

P Vranckx, F W G Leebeek, J G P Tijssen, J Koolen, F Stammen, J-P R Herman, R J de Winter, A W J van T Hof, B Backx, W Lindeboom and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Thrombosis and haemostasis, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01442792 (Prospective, Multi-center, Randomized, Heparin-controlled Dose-finding Trial to Evaluate the Efficacy and Safety of Rivaroxaban, a Direct Factor Xa Inhibitor, on the Background of Standard Dual Antiplatelet Therapy to Support Elective Percutaneous Coronary Intervention), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 7% 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.

NCT01442792 phase2completednot on this map

Prospective, Multi-center, Randomized, Heparin-controlled Dose-finding Trial to Evaluate the Efficacy and Safety of Rivaroxaban, a Direct Factor Xa Inhibitor, on the Background of Standard Dual Antiplatelet Therapy to Support Elective Percutaneous Coronary Intervention

TypeinterventionalSponsorBayerRan2011 to 2013Enrolled108ConditionsCardiovascular Disease, Coronary Artery DiseaseArmsUFH, Rivaroxaban (Xarelto, BAY59-7939), Rivaroxaban (Xarelto, BAY59-7939) and UFH
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Site-Specific Antithrombotic Therapy: 24-Month Outcomes of the Randomized DESyne BDS Plus Trial Using a Novel Triple-Drug Eluting Coronary Implant With Two Anticoagulants and Sirolimus.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
    Trial
  4. Review
  5. Article
  6. Review
  7. Review
  8. Assessment and mitigation of bleeding risk in atrial fibrillation and venous thromboembolism: A Position Paper from the ESC Working Group on Thrombosis, in collaboration with the European Heart Rhythm Association, the Association for Acute CardioVascular Care and the Asia-Pacific Heart Rhythm Society.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2022
    Article
  9. The WOEST 2 registry : A prospective registry on antithrombotic therapy in atrial fibrillation patients undergoing percutaneous coronary intervention.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2022
    Article
  10. Article
  11. Observational
  12. How cardiologists manage antithrombotic treatment of patients with atrial fibrillation undergoing percutaneous coronary stenting: the WOEST survey 2018.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2021
    Article
  13. Review
  14. Review
  15. Efficacy and Safety of Antiplatelet Therapy Plus Xa Factor Inhibitors in Patients with Coronary Heart Disease: A Meta-Analysis.Medical science monitor : international medical journal of experimental and clinical research · 2019
    Review
  16. Triple Therapy: When, if Ever?Current treatment options in cardiovascular medicine · 2018
    Review
  17. Antithrombotic management in patients with percutaneous coronary intervention requiring oral anticoagulation.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2016
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 3 countries.

P Vranckx
F W G Leebeek
J G P Tijssen
J Koolen
F Stammen
J-P R Herman
R J de Winter
A W J van T Hof
B Backx
W Lindeboom
S-Y Kim
B Kirsch
M van Eickels
F Misselwitz
F W A VerheugtProf. Freek W. A. Verheugt MD, PhD, Department of Cardiology, Heartcenter, Oosterpark 9, AC Amsterdam 1091, the Netherlands, Tel.: + 31 20 5993421, Fax: +31 20 5993997, E-mail: f. w. a.verheugt@olvg.nl.
Bayer (Germany) · DEAmsterdam UMC Location University of Amsterdam · NLCardialysis (Netherlands) · NLAZ Delta · BEErasmus MC · NLGGD Amsterdam · NLHartcentrum Hasselt · BEIsala · NLOLVG · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients on rivaroxaban requiring percutaneous coronary intervention (PCI) represent a clinical conundrum. We aimed to investigate whether rivaroxaban, with or without an additional bolus of unfractionated heparin (UFH), effectively inhibits coagulation activation during PCI. Stable patients (n=108) undergoing elective PCI and on stable dual antiplatelet therapy were randomised (2:2:2:1) to a short treatment course of rivaroxaban 10 mg (n=30), rivaroxaban 20 mg (n=32), rivaroxaban 10 mg plus UFH (n=30) or standard peri-procedural UFH (n=16). Blood samples for markers of thrombin generation and coagulation activation were drawn prior to and at 0, 0.5, 2, 6-8 and 48 hours (h) after start of PCI. In patients treated with rivaroxaban (10 or 20 mg) and patients treated with rivaroxaban plus heparin, the levels of prothrombin fragment 1 + 2 at 2 h post-PCI were 0.16 [0.1] nmol/l (median) [interquartile range, IQR] and 0.17 [0.2] nmol/l, respectively. Thrombin-antithrombin complex values at 2 h post-PCI were 3.90 [6.8]µg/l and 3.90 [10.1] µg/l, respectively, remaining below the upper reference limit (URL) after PCI and stenting. This was comparable to the control group of UFH treatment alone. However, median values for thrombin-antithrombin complex passed above the URL with increasing tendency, starting at 2 h post-PCI in the UFH-alone arm but not in rivaroxaban-treated patients. In this exploratory trial, rivaroxaban effectively suppressed coagulation activation after elective PCI and stenting.

Indexed as

Percutaneous Coronary InterventionAgedAnticoagulantsAntithrombin IIIBiomarkersCoronary DiseaseDrug Therapy, CombinationElective Surgical ProceduresFactor Xa InhibitorsFemaleFibrinolytic AgentsHeparinHumansMaleMiddle AgedPeptide FragmentsAnticoagulantsAntithrombin IIIantithrombin III-protease complexBiomarkersFactor Xa InhibitorsFibrinolytic AgentsHeparinPeptide FragmentsPeptide HydrolasesPlatelet Aggregation InhibitorsProthrombinprothrombin fragment 1.2RivaroxabanThrombinAnticoagulationcoronary artery diseaserivaroxabanthrombosis

Identifiers

PMID25925992
PMCPMC6374984
OpenAlexW1741176642

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.