Evidence map›Paper›PMID 25975659›Full record

Trial reportEuropean heart journal2015

Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation.

Riccardo Cappato, Francis E Marchlinski, Stefan H Hohnloser, Gerald V Naccarelli, Jim Xiang, David J Wilber, Chang-Sheng Ma, Susanne Hess, Darryl S Wells, George Juang and 8 more

3 registry-linked trialsOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 160 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
160citing papers in PubMed, 17 pooled it
38.7field-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.

NCT01729871 phase3completednot on this map

A Randomized, Open-label, Active-controlled Multi-center Study to Assess Safety of Uninterrupted Rivaroxaban vs. Usual Care in Subjects Undergoing Catheter Ablation Therapy for Atrial Fibrillation

TypeinterventionalSponsorJanssen Scientific Affairs, LLCRan2013 to 2014Enrolled253ConditionsAtrial FibrillationArmsrivaroxaban, uninterrupted vitamin K antagonist (VKA)
NCT02942576 phase3completednot on this mapstarted 2017, after this paper: background citation

A Prospective, Randomized, Open-Label, Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban vs. VKA in Subjects Undergoing Catheter Ablation of Non-valvular Atrial Fibrillation (ELIMINATE-AF)

TypeinterventionalSponsorDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyRan2017 to 2018Enrolled632ConditionsAtrial FibrillationArmsEdoxaban, VKA-Based Regimen
NCT04315974 unknown statusnot on this mapstarted 2020, after this paper: background citation

Italian Registry In the Setting of AF Ablation With Rivaroxaban

Typeobservational_patient_registrySponsorDr Carlo LavalleRan2020 to 2022Enrolled250ConditionsAtrial FibrillationArmsRivaroxaban, Catheter ablation
3 · Its place in the literature

Who cites it

160 citing papers in PubMed, 17 syntheses or guidelines pooled it, 426 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Guideline
  5. Meta-analysis of controlled studies on minimally interrupted vs. continuous use of non-vitamin K antagonist oral anticoagulants in catheter ablation for atrial fibrillation.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 · 2021
    Pooled it
  6. Meta-analysis of the safety and efficacy of using minimally interrupted novel oral anticoagulants in patients undergoing catheter ablation for atrial fibrillation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021
    Pooled it
  7. Meta-analysis of efficacy and safety of new oral anticoagulants compared with warfarin in Japanese patients undergoing catheter ablation for atrial fibrillation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2020
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Meta-analysis of safety and efficacy of oral anticoagulants in patients requiring catheter ablation for atrial fibrillation.Cardiovascular revascularization medicine : including molecular interventions · 2019
    Pooled it
  11. Guideline
  12. Guideline
  13. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation.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 · 2018
    Guideline
  14. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary.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 · 2018
    Guideline
  15. Efficacy and safety of rivaroxaban compared with vitamin K antagonists for peri-procedural anticoagulation in catheter ablation of atrial fibrillation: a systematic review and meta-analysis.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 · 2016
    Pooled it
  16. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society.Heart rhythm · 2012
    Guideline
  17. Benefits and Risks Associated with Long-term Oral Anticoagulation after Successful Atrial Fibrillation Catheter Ablation: Systematic Review and Meta-analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  18. Trial
  19. Trial
  20. Trial

100 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 17 institutions in 7 countries.

Riccardo CappatoArrhythmia and Electrophysiology Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy Gavazzeni Hospital, Second Arrhythmia and EP Unit, Bergamo, Italy.
Francis E MarchlinskiSection of Cardiac Electrophysiology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
Stefan H HohnloserDepartment of Cardiology, Division of Clinical Electrophysiology, JW Goethe University, Frankfurt, Germany.
Gerald V NaccarelliHeart and Vascular Institute, Penn State University College of Medicine, Hershey, PA, USA.
Jim XiangBiostatistics and Programming, Janssen Research & Development, LLC, Raritan, NJ, USA.
David J WilberDepartment of Medicine, Cardiovascular Institute, Loyola University, Chicago, IL, USA.
Chang-Sheng MaCardiology Division, Beijing AnZhen Hospital, Capital Medical University (CMU), Beijing, China.
Susanne HessMedical Affairs, Bayer Healthcare Pharmaceuticals, Berlin, Germany.
Darryl S WellsCardiac Electrophysiology, Swedish Heart & Vascular Institute, Seattle, WA, USA.
George JuangHeart and Arrhythmia Care of New York, Manhasset, NY, USA.
Johan VijgenDivision of Cardiac Electrophysiology, Jessa Hospitals, Hasselt, Belgium.
Burkhard J HüglDepartment of Cardiology and Rhythmology, Marienhaus Klinikum St. Elisabeth, Neuwied, Germany.
Richard BalasubramaniamDepartment of Cardiology, Royal Bournemouth Hospital, Bournemouth, United Kingdom.
Christian De ChillouDépartment de Cardiologie, CHU de Nancy, Nancy, France.
D Wyn DaviesWaller Department of Cardiology, St. Mary's Hospital, Imperial College NHS Trust, London, United Kingdom.
L Eugene FieldsMedical Affairs, Janssen Scientific Affairs, LLC, Raritan, NJ, USA.
Andrea NataleTexas Cardiac Arrhythmia Institute at St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX 78705, USA dr.natale@gmail.com.
VENTURE-AF Investigators
Bayer (Germany) · DEBeijing Anzhen Hospital · CNGoethe University Frankfurt · DEHospital of the University of Pennsylvania · USHumanitas Gavazzeni · ITJanssen Scientific Affairs (United States)Janssen (United States) · USJessa Hospital · BELoyola University Chicago · USMarienhaus Klinikum Hetzelstift Neustadt · DEPenn State Milton S. Hershey Medical Center · USRoyal Bournemouth Hospital · GBSociété Française de Cardiologie · FRSt David's Medical Center · USSt Mary's Hospital · GBSwedish Medical Center · USThe Arrhythmia Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsVENTURE-AF is the first prospective randomized trial of uninterrupted rivaroxaban and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) undergoing catheter ablation (CA). METHODS AND

resultsTrial size was administratively set at 250, the protocol-specified target. Events were independently and blindly adjudicated. We randomly assigned 248 NVAF patients to uninterrupted rivaroxaban (20 mg once-daily) or to an uninterrupted VKA prior to CA and for 4 weeks afterwards. The primary endpoint was major bleeding events after CA. Secondary endpoints included thromboembolic events (composite of stroke, systemic embolism, myocardial infarction, and vascular death) and other bleeding or procedure-attributable events. Patients were 59.5 ± 10 years of age, 71% male, 74% paroxysmal AF, and had a CHA2DS2-VASc score of 1.6. The average total heparin dose used to manage activated clotting time (ACT) was slightly higher (13 871 vs. 10 964 units; P < 0.001) and the mean ACT level attained slightly lower (302 vs. 332 s; P < 0.001) in rivaroxaban and VKA arms, respectively. The incidence of major bleeding was low (0.4%; 1 major bleeding event). Similarly, thromboembolic events were low (0.8%; 1 ischemic stroke and 1 vascular death). All events occurred in the VKA arm and all after CA. The number of any adjudicated events (26 vs. 25), any bleeding events (21 vs. 18), and any other procedure-attributable events (5 vs. 5) were similar.

conclusionIn patients undergoing CA for AF, the use of uninterrupted oral rivaroxaban was feasible and event rates were similar to those for uninterrupted VKA therapy. NAME OF THE TRIAL REGISTRY: Clinicaltrials.gov trial registration number is NCT01729871.

Indexed as

Anti-Arrhythmia AgentsAtrial FibrillationBlood Loss, SurgicalCatheter AblationDrug Administration ScheduleFactor Xa InhibitorsFemaleHumansMaleMiddle AgedOperative TimeProspective StudiesPulmonary VeinsRecurrenceReoperationRivaroxabanAnti-Arrhythmia AgentsFactor Xa InhibitorsRivaroxabanVitamin KAtrial fibrillationCatheter ablationOral anticoagulantThromboembolismUninterrupted

Identifiers

PMID25975659
PMCPMC4508487
OpenAlexW2120775803

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.