Evidence map›Paper›PMID 19144937›Full record

Trial reportThe New England journal of medicine2009

Fractional flow reserve versus angiography for guiding percutaneous coronary intervention.

Pim A L Tonino, Bernard De Bruyne, Nico H J Pijls, Uwe Siebert, Fumiaki Ikeno, Marcel van' t Veer, Volker Klauss, Ganesh Manoharan, Thomas Engstrøm, Keith G Oldroyd and 4 more

29 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 29 registered trials, which are not on this map. Cited by 1,368 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,368citing papers in PubMed, 10 pooled it
183.5field-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.

NCT05392959 phase4terminatedstarted 2022, after this paper: background citation

Effect of the Antidiabetic Drug DAPAgliflozin on the Coronary Macrovascular and MICROvascular Function in Type 2 Diabetic Patients

Ran2022Enrolled4Registered outcomes3Posted comparisons0ConditionsDiabetes Mellitus, Type 2ArmsDapagliflozin 10 mg Tab, Placebo
Open the trial in the graph
NCT00267774 nacompletednot on this map

Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.)

TypeinterventionalSponsorStanford UniversityRan2006 to 2015Enrolled1,005ConditionsCoronary ArteriosclerosisArmsFractional flow reserve, Angio-guided PCI
NCT01161121 phase1completednot on this mapstarted 2010, after this paper: background citation

Utilization of Lexiscan (Regadenoson)in the Cardiac Catheterization Lab to Achieve Maximal Hyperemia for Coronary Physiologic Assessment With Fractional Flow Reserve

TypeinterventionalSponsorSt. Louis UniversityRan2010 to 2013Enrolled46ConditionsCoronary Artery DiseaseArmsadenosine, regadenoson
NCT01764334 phase4unknown statusnot on this mapstarted 2011, after this paper: background citation

A Developmental Clinical Study of Management Guided by Coronary Angiography Combined With Fractional Flow Reserve (FFR) Measurement Versus Management Guided by Coronary Angiography Alone(Standard Care) in Patients With Non-ST Elevation MI.

TypeinterventionalSponsorNHS National Waiting Times Centre BoardRan2011 to 2020Enrolled350ConditionsNonST Elevation Myocardial Infarction, Myocardial InfarctionArmsFractional flow reserve
NCT01873560 completednot on this mapstarted 2013, after this paper: background citation

Influence of Fractional Flow Reserve (FFR) on the Clinical OutcomEs of PERcutaneouS Coronary Intervention (PCI): A ProspECTIVE, Multicenter FFR Registry

Typeobservational_patient_registrySponsorInje UniversityRan2013 to 2016Enrolled1,250ConditionsCoronary Disease
NCT02219802 naunknown statusnot on this mapstarted 2014, after this paper: background citation

Revascularization With Paclitaxel-coated Balloon Angioplasty Versus Drug-eluting Stenting in Acute Myocardial Infarction - a Randomized Controlled Trial.

TypeinterventionalSponsorOnze Lieve Vrouwe GasthuisRan2014Enrolled120ConditionsCoronary Artery Disease, Acute Myocardial InfarctionArmsTreatment according arm
NCT02527044 naactive not recruitingnot on this mapstarted 2015, after this paper: background citation

Impact of Preoperative FFR on Arterial Bypass Graft Functionality: Towards a New CABG Paradigm

TypeinterventionalSponsorOttawa Heart Institute Research CorporationRan2015 to 2028Enrolled120ConditionsHeart DiseaseArmsFractional Flow Reserve (FFR)
NCT02577484 unknown statusnot on this mapstarted 2015, after this paper: background citation

Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement: the ACIST-FFR Study

TypeobservationalSponsorAcist Medical SystemsRan2015 to 2017Enrolled240ConditionsCoronary Artery DiseaseArmsRXi System, Pressure Wire
NCT02590926 completednot on this mapstarted 2014, after this paper: background citation

Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions

Typeobservational_patient_registrySponsorA.O.U. Città della Salute e della ScienzaRan2014 to 2017Enrolled285ConditionsFractional Flow Reserve, MyocardialArmsFractional Flow Reserve, Myocardial
NCT02892903 naunknown statusnot on this mapstarted 2016, after this paper: background citation

A Randomised Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease.

TypeinterventionalSponsorUniversity Hospital Southampton NHS Foundation TrustRan2016 to 2020Enrolled1,100ConditionsChest Pain, Stable Angina, Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary SyndromeArmsRoutine Measurement of FFR
NCT02943954 naunknown statusnot on this mapstarted 2016, after this paper: background citation

FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2016 to 2022Enrolled1,170ConditionsAcute ST Segment Elevation Myocardial Infarction, Acute Myocardial Infarction, Multi Vessel Coronary Artery DiseaseArmsAngiography guided PCI, Fractional Flow Reserve (FFR)
NCT03033810 unknown statusnot on this mapstarted 2017, after this paper: background citation

FFR Versus iFR in Assessment of Hemodynamic Lesion Significance Using Gene Polymorphisms and Lesion Morphology Assessed by OCT (FiGARO Trial)

TypeobservationalSponsorGeneral University Hospital, PragueRan2017 to 2019Enrolled200ConditionsHemodynamics, Coronary Circulation, Tomography, Optical Coherence, Endothelial CellsArmsFractional flow reserve and instantaneous wave-free ratio
NCT03044964 phase4unknown statusnot on this mapstarted 2017, after this paper: background citation

Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention

TypeinterventionalSponsorAmit Malhotra, MDRan2017 to 2017Enrolled40ConditionsAnginaArmsRanolazine, Placebo
NCT03227588 unknown statusnot on this mapstarted 2017, after this paper: background citation

Evaluation of the Opsens Fractional Flow Reserve (FFR) Wire as a "Work Horse" Wire

Typeobservational_patient_registrySponsorCentral Arkansas Veterans Healthcare SystemRan2017 to 2019Enrolled1,000ConditionsCoronary Artery DiseaseArmsFractional Flow Reserve
NCT03383718 completednot on this mapstarted 2014, after this paper: background citation

Comparison of Dobutamine Stress Echocardiography and Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease: Stable and Non-culprit Lesions Investigation

TypeobservationalSponsorBajcsy-Zsilinszky HospitalRan2014 to 2019Enrolled200ConditionsIschemic Heart DiseaseArmsRevascularisation, Optimal Medical Treatment/OMT
NCT03656848 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease (The FAVOR III China Study)

TypeinterventionalSponsorChina National Center for Cardiovascular DiseasesRan2018 to 2025Enrolled3,847ConditionsCoronary Artery Disease, Myocardial Ischaemia, Coronary Circulation, Coronary StenosisArmsQFR, Angiography
NCT03767621 active not recruitingnot on this mapstarted 2019, after this paper: background citation

Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR (iLITRO Study)

Typeobservational_patient_registrySponsorFundación EPICRan2019 to 2026Enrolled300ConditionsCoronary Artery Disease, Left Main Coronary Artery Stenosis, Left Main Coronary Artery Disease, Restenosis, CoronaryArmsIndication of revascularization
NCT03988881 unknown statusnot on this mapstarted 2017, after this paper: background citation

Assessment of NOn-culprit Lesions With dobutamiNe Stress eChocardiography, compUted Tomography and Fractional fLow Reserve in Patients With Acute

TypeobservationalSponsorSemmelweis University Heart and Vascular CenterRan2017 to 2021Enrolled100ConditionsFractional Flow ReserveArmsRevascularization
NCT04037163 completednot on this mapstarted 2010, after this paper: background citation

CCTA-FFR Registry for Development of Comprehensive Risk Prediction Model

TypeobservationalSponsorSeoul National University HospitalRan2010 to 2019Enrolled747ConditionsCoronary Artery DiseaseArmsFractional flow reserve, Coronary CT angiography
NCT04144881 nacompletednot on this mapstarted 2019, after this paper: background citation

Angiographic Control Vs. Ischemia-driven Management of Patients Undergoing Percutaneous Revascularization of the Unprotected Left Main Coronary Artery with Second-generation Drug Eluting Stents: the PULSE Trial

TypeinterventionalSponsorA.O.U. Città della Salute e della ScienzaRan2019 to 2024Enrolled606ConditionsAcute Coronary Syndrome, Stable Chronic Angina, Coronary Artery Disease, Left Main Coronary Artery DiseaseArmscoronary computed tomography
NCT04547231 unknown statusnot on this mapstarted 2020, after this paper: background citation

Impact of Stenosis and Plaque Features in Coronary CT Angiography, Physiologic Assessment and Pharmacotherapy on the Clinical Outcomes After Invasive Coronary Angiography

TypeobservationalSponsorSeoul National University HospitalRan2020 to 2025Enrolled992ConditionsCoronary Artery DiseaseArmsFractional flow reserve, Coronary CT angiography
NCT04575207 naunknown statusnot on this mapstarted 2021, after this paper: background citation

A Prospective, Multicenter, Blinded, Randomized, Noninferiority Clinical Trial of Coronary Angiography Fractional Flow Reserve (caFFR) Versus Fractional Flow Reserve (FFR) to Guide Percutaneous Coronary Intervention(Flash FFR Ⅱ )

TypeinterventionalSponsorPeking University First HospitalRan2021 to 2025Enrolled2,132ConditionsCoronary Artery Disease, Coronary Stenosis, Myocardial Ischaemia, Coronary CirculationArmscaFFR, FFR
NCT04777513 completednot on this mapstarted 2020, after this paper: background citation

Evaluation of Diagnostic Accuracy, Safety, and Cost-Effectiveness of the Non-Invasive Cardiolens FFR-CT Pro Method to Measure the Fractional Flow Reserve in Diagnostics of Chronic Coronary Syndromes Versus the Standard Diagnostic Modalities. A Multicentre Post-marketing Trial of a Class 2a Medical Device, Cardiolens FFR-CT Pro - Software for Non-invasive Determination of Haemodynamic Parameters in Coronary Arteries.

Typeobservational_patient_registrySponsorHemolens Diagnostics Sp. z o.o.Ran2020 to 2023Enrolled450ConditionsStable Ischemic Heart Disease, Coronary Artery DiseaseArmsCCTA (Coronary Computed Tomography Angiography), ICA (Invasive Coronary Angiography), FFR (Fractional Flow Reserve), CNBP measurement, Cardiolens FFR-CT Pro
NCT04975425 completednot on this mapstarted 2021, after this paper: background citation

Effects of Guiding Catheter on Fractional Flow Reserve and Non-Hyperemic Pressure Ratios for the Assessment of Coronary Artery Stenoses - Disengage @Rest

TypeobservationalSponsorFederico II UniversityRan2021 to 2022Enrolled200ConditionsCoronary Artery DiseaseArmsFractional Flow Reserve
NCT05027984 naactive not recruitingnot on this mapstarted 2021, after this paper: background citation

An Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome (the INTER-CLIMA Trial)

TypeinterventionalSponsorCentro per la Lotta Contro l'Infarto - Fondazione OnlusRan2021 to 2030Enrolled1,425ConditionsCoronary Artery Disease, Coronary Disease, Ischemic Heart DiseaseArmsOptical coherence tomography, iFR/FFR/RFR
NCT05163327 withdrawnnot on this mapstarted 2023, after this paper: background citation

Oxygen-enhanced Magnetic Resonance Imaging (OE-MRI) of the Heart: A Feasibility Study

TypeobservationalSponsorManchester University NHS Foundation TrustRan2023 to 2023Enrolled0ConditionsCoronary Artery DiseaseArmsOxygen-enhanced Cardiac MRI
NCT06216847 recruitingnot on this mapstarted 2024, after this paper: background citation

Clinical Outcomes of Patients With Coronary Artery Disease Cohort Study

Typeobservational_patient_registrySponsorShenyang Northern HospitalRan2024 to 2030Enrolled10,000ConditionsCoronary Heart Disease (CHD)
NCT06305572 completednot on this mapstarted 2019, after this paper: background citation

Diagnostic Accuracy of Quantitative Flow Ratio for Hemodynamic Assessment of Coronary Artery Stenosis: Prospective Observational Study

Typeobservational_patient_registrySponsorSeoul National University HospitalRan2019 to 2023Enrolled280ConditionsCoronary Artery DiseaseArmsQFR
NCT06844721 active not recruitingnot on this map

Association Between Murray Law-Based Angiography-Derived Fractional Flow Reserve and Outcomes After Coronary Artery Bypass Grafting

Typeobservational_patient_registrySponsorSeoul National University HospitalRan2008 to 2026Enrolled945ConditionsCoronary Artery Bypass Graft Surgery (CABG)
3 · Its place in the literature

Who cites it

1,368 citing papers in PubMed, 10 syntheses or guidelines pooled it, 4,152 citations in OpenAlex.

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  15. Changes in non-culprit coronary lesions with PCSK9 inhibitors: the randomised, placebo-controlled FITTER trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
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  18. Coronary revascularisation deferral based on quantitative flow ratio or fractional flow reserve: a post hoc analysis of the FAVOR III Europe trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
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1,308 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 5 countries.

Pim A L ToninoCatharina Hospital, Eindhoven, The Netherlands.
Bernard De Bruyne
Nico H J Pijls
Uwe Siebert
Fumiaki Ikeno
Marcel van' t Veer
Volker Klauss
Ganesh Manoharan
Thomas Engstrøm
Keith G Oldroyd
Peter N Ver Lee
Philip A MacCarthy
William F Fearon
FAME Study Investigators
Catharina Ziekenhuis · NLStanford Medicine · USKing's College Hospital · GBMassachusetts General Hospital · USOnze Lieve Vrouwziekenhuis Hospital · BERadboud University Nijmegen · NLRigshospitalet · DKRoyal Victoria Hospital · GBWestern Infirmary · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with multivessel coronary artery disease who are undergoing percutaneous coronary intervention (PCI), coronary angiography is the standard method for guiding the placement of the stent. It is unclear whether routine measurement of fractional flow reserve (FFR; the ratio of maximal blood flow in a stenotic artery to normal maximal flow), in addition to angiography, improves outcomes.

methodsIn 20 medical centers in the United States and Europe, we randomly assigned 1005 patients with multivessel coronary artery disease to undergo PCI with implantation of drug-eluting stents guided by angiography alone or guided by FFR measurements in addition to angiography. Before randomization, lesions requiring PCI were identified on the basis of their angiographic appearance. Patients assigned to angiography-guided PCI underwent stenting of all indicated lesions, whereas those assigned to FFR-guided PCI underwent stenting of indicated lesions only if the FFR was 0.80 or less. The primary end point was the rate of death, nonfatal myocardial infarction, and repeat revascularization at 1 year.

resultsThe mean (+/-SD) number of indicated lesions per patient was 2.7+/-0.9 in the angiography group and 2.8+/-1.0 in the FFR group (P=0.34). The number of stents used per patient was 2.7+/-1.2 and 1.9+/-1.3, respectively (P<0.001). The 1-year event rate was 18.3% (91 patients) in the angiography group and 13.2% (67 patients) in the FFR group (P=0.02). Seventy-eight percent of the patients in the angiography group were free from angina at 1 year, as compared with 81% of patients in the FFR group (P=0.20).

conclusionsRoutine measurement of FFR in patients with multivessel coronary artery disease who are undergoing PCI with drug-eluting stents significantly reduces the rate of the composite end point of death, nonfatal myocardial infarction, and repeat revascularization at 1 year. (ClinicalTrials.gov number, NCT00267774.)

Indexed as

Coronary AngiographyDrug-Eluting StentsFractional Flow Reserve, MyocardialAgedAngioplasty, Balloon, CoronaryCoronary Artery DiseaseCoronary RestenosisFemaleFollow-Up StudiesHealth Care CostsHumansKaplan-Meier EstimateLength of StayMaleMiddle AgedMyocardial Infarction

Identifiers

PMID19144937
OpenAlexW2115416118

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 23 more above

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.