Evidence map›Paper›PMID 38621698›Full record

Observational studyEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery2024

On-X aortic valve replacement patients treated with low-dose warfarin and low-dose aspirin.

Aung Y Oo, Mahmoud Loubani, Marc W Gerdisch, Joseph Zacharias, Geoffrey M Tsang, Michael J Perchinsky, Robert Carl Hagberg, Mark Joseph, Mohanakrishnan Sathyamoorthy

Registry-linked trialAbstract readObservational StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02677974 (On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT02677974 active not recruitingnot on this map

On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study

Typeobservational_patient_registrySponsorOn-X Life Technologies, Inc.Ran2015 to 2027Enrolled510ConditionsThrombotic and Bleeding EventsArmsOn-X Aortic Heart Valve replacement
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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

9 authors.

Aung Y OoDepartment of Cardiovascular Surgery, Bart's Health NHS Trust, London, UK.
Mahmoud LoubaniDepartment of Cardiothoracic Surgery, Hull University Teaching Hospitals NHS Trust, Hull, UK.
Marc W GerdischDepartment of Cardiothoracic Surgery, Franciscan Health, Indianapolis, IN, USA.
Joseph ZachariasDepartment of Cardiothoracic Surgery, Blackpool Teaching Hospitals Foundation Trust, Blackpool, UK.
Geoffrey M TsangDepartment of Cardiac Surgery, Southampton General Hospital, Southampton, UK.
Michael J PerchinskyDepartment of Surgery, Royal Jubilee Hospital, Victoria, BC, Canada.
Robert Carl HagbergDepartment of Cardiac Surgery, Hartford Hospital, Hartford, CT, USA.
Mark JosephDepartment of Surgery, Virginia Tech Carilion School of Medicine, Roanoke, VA, USA.
Mohanakrishnan SathyamoorthyDepartment of Internal Medicine, Burnett School of Medicine at TCU, Fort Worth, TX, USA.

Funding

On-X Life Technologies, Inc.
6 · The paper itself

Abstract

objectivesTo assess if warfarin targeted to international normalized ratio (INR) 1.8 (range 1.5-2.0) is safe for all patients with an On-X aortic mechanical valve.

methodsThis prospective, observational registry follows patients receiving warfarin targeted at an INR of 1.8 (range 1.5-2.0) plus daily aspirin (75-100 mg) after On-X aortic valve replacement. The primary end point is a composite of thromboembolism, valve thrombosis and major bleeding. Secondary end points include the individual rates of thromboembolism, valve thrombosis and major bleeding, as well as the composite in subgroups of home or clinic-monitored INR and risk categorization for thromboembolism. The control was the patient group randomized to standard-dose warfarin (INR 2.0-3.0) plus daily aspirin 81 mg from the PROACT trial.

resultsA total of 510 patients were enroled at 23 centres in the UK, USA and Canada. Currently, the median follow-up duration is 3.4 years, and median achieved INR is 1.9. The primary composite end point rate in the low INR patients is 2.31% vs 5.39% (95% confidence interval 4.12-6.93%) per patient-year in the PROACT control group, constituting a 57% reduction. Results are consistent in subgroups of home or clinic-monitored, and high-risk patients, with reductions of 56%, 57% and 57%, respectively. Major and total bleeding are decreased by 85% and 73%, respectively, with similar rates of thromboembolic events. No valve thrombosis occurred.

conclusionsInterim results suggest that warfarin targeted at an INR of 1.8 (range 1.5-2.0) plus aspirin is safe and effective in patients with an On-X aortic mechanical valve with or without home INR monitoring.

Indexed as

AnticoagulantsAortic ValveAspirinHeart Valve Prosthesis ImplantationInternational Normalized RatioThromboembolismWarfarinAgedFemaleHeart Valve ProsthesisHemorrhageHumansMaleMiddle AgedProspective StudiesThrombosisAnticoagulantsAspirinWarfarinAnticoagulationAortic valve replacementLow-dose warfarinMechanical heart valveOn-X valveProsthetic valve

Identifiers

PMID38621698
PMCPMC11136449

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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.