Evidence map›Paper›PMID 29097450›Full record

Trial reportCirculation2018

Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation).

William F Fearon, Takeshi Nishi, Bernard De Bruyne, Derek B Boothroyd, Emanuele Barbato, Pim Tonino, Peter Jüni, Nico H J Pijls, Mark A Hlatky, FAME 2 Trial Investigators

4 registry-linked trialsAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Circulation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 109 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 3 pooled it
–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.

NCT01132495 nacompletednot on this map

Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease

TypeinterventionalSponsorAbbott Medical DevicesRan2010 to 2015Enrolled1,170ConditionsCoronary Artery DiseaseArmsStenting plus OMT, OMT, Standard of care
NCT04012281 completednot on this map

International Post PCI FFR Registry for Prognostic Factors After Coronary Stenting

Typeobservational_patient_registrySponsorSeoul National University HospitalRan2010 to 2019Enrolled2,228ConditionsCoronary DiseaseArmsPercutaneous coronary intervention
NCT04684043 unknown statusnot on this mapstarted 2020, after this paper: background citation

Prognostic Implications of Physiologic Investigation After Revascularization With Stent

TypeobservationalSponsorBon-Kwon KooRan2020 to 2021Enrolled5,100ConditionsCoronary DiseaseArmsPercutaneous coronary intervention
NCT05672862 completednot on this mapstarted 2021, after this paper: background citation

International Post-PCI FFR Registry for Extended Follow up Outcomes After Coronary Stenting

TypeobservationalSponsorBon-Kwon KooRan2021 to 2022Enrolled2,128ConditionsCoronary DiseaseArmsPercutaneous coronary intervention
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  12. Iontronic tip-sensing guidewires.Nature biomedical engineering · 2026
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49 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

William F FearonDivision of Cardiovascular Medicine (W.F.F., T.N., M.A.H.) wfearon@stanford.edu.
Takeshi NishiDivision of Cardiovascular Medicine (W.F.F., T.N., M.A.H.).
Bernard De BruyneStanford University School of Medicine and Stanford Cardiovascular Institute, CA. Cardiovascular Center Aalst, Belgium (B.D.B., E.B.).
Derek B BoothroydQuantitative Sciences Unit (D.B.B.).
Emanuele BarbatoStanford University School of Medicine and Stanford Cardiovascular Institute, CA. Cardiovascular Center Aalst, Belgium (B.D.B., E.B.).
Pim ToninoCatharina Hospital, Eindhoven, the Netherlands (P.T., N.H.J.P.).
Peter JüniApplied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Ontario, Canada (P.J.).
Nico H J PijlsCatharina Hospital, Eindhoven, the Netherlands (P.T., N.H.J.P.).
Mark A HlatkyDivision of Cardiovascular Medicine (W.F.F., T.N., M.A.H.).
FAME 2 Trial Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious studies found that percutaneous coronary intervention (PCI) does not improve outcome compared with medical therapy (MT) in patients with stable coronary artery disease, but PCI was guided by angiography alone. FAME 2 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) compared PCI guided by fractional flow reserve with best MT in patients with stable coronary artery disease to assess clinical outcomes and cost-effectiveness.

methodsA total of 888 patients with stable single-vessel or multivessel coronary artery disease with reduced fractional flow reserve were randomly assigned to PCI plus MT (n=447) or MT alone (n=441). Major adverse cardiac events included death, myocardial infarction, and urgent revascularization. Costs were calculated on the basis of resource use and Medicare reimbursement rates. Changes in quality-adjusted life-years were assessed with utilities determined by the European Quality of Life-5 Dimensions health survey at baseline and over follow-up.

resultsMajor adverse cardiac events at 3 years were significantly lower in the PCI group compared with the MT group (10.1% versus 22.0%;

conclusionsPCI of lesions with reduced fractional flow reserve improves long-term outcome and is economically attractive compared with MT alone in patients with stable coronary artery disease. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01132495.

Indexed as

Cardiac CatheterizationFractional Flow Reserve, MyocardialPercutaneous Coronary InterventionCoronary AngiographyCoronary Artery DiseaseCost-Benefit AnalysisEuropeHealth Care CostsHumansNorth AmericaPredictive Value of TestsProspective StudiesQuality of LifeRisk FactorsTime FactorsTreatment Outcomeangiographycoronary artery diseasefractional flow reserve, myocardialpercutaneous coronary interventionstents

Identifiers

PMID29097450

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.