Evidence map›Paper›PMID 30596995›Full record

SynthesisEuropean heart journal2019

Fractional flow reserve-guided percutaneous coronary intervention vs. medical therapy for patients with stable coronary lesions: meta-analysis of individual patient data.

Frederik M Zimmermann, Elmir Omerovic, Stephane Fournier, Henning Kelbæk, Nils P Johnson, Martina Rothenbühler, Panagiotis Xaplanteris, Mohamed Abdel-Wahab, Emanuele Barbato, Dan Eik Høfsten and 9 more

7 registry-linked trialsOpen access · bronzeAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in European heart journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 70 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 1 pooled it
26.5field-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.

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
NCT01399736 nacompletednot on this map

Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease

TypeinterventionalSponsorMaasstad HospitalRan2011 to 2018Enrolled885ConditionsMyocardial Infarction, Multivessel Coronary Artery DiseaseArmsFFR-guided revascularisation strategy, randomised to guidelines group
NCT01960933 naunknown statusnot on this map

Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention

TypeinterventionalSponsorRigshospitalet, DenmarkRan2011 to 2024Enrolled650ConditionsST-elevation Myocardial Infarction, Multi Vessel DiseaseArmsPercutaneous coronary intervention, FFR
NCT04048005 unknown statusnot on this map

RELATionship bEtween Lesion-level Invasive Fractional Flow Reserve AND Endothelial Wall Shear Stress the RELATE FFR and WSS Study

TypeobservationalSponsorA.O.U. Città della Salute e della ScienzaRan2017 to 2020Enrolled200ConditionsStable Angina, Acute Coronary Syndrome, Coronary Artery DiseaseArmsFractional flow reserve
NCT07446023 narecruitingnot on this mapstarted 2025, after this paper: background citation

Diagnostic Accuracy of Intravascular Ultrasound-Derived Fractional Flow Reserve for Online Assessment of Functionally Significant Coronary Stenosis: A Multicenter Prospective Study

TypeinterventionalSponsorChina National Center for Cardiovascular DiseasesRan2025 to 2026Enrolled292ConditionsPercutaneous Coronary Intervention, Intravenous Ultrasound, Coronary PhysiologyArmsUltrasound-Derived Fractional Flow Reserve Computational System
NCT07551518 completednot on this mapstarted 2024, after this paper: background citation

Retrospective Algorithm Development and Validation of Intravascular Ultrasound-Derived Fractional Flow Reserve (IvusFFR): A Single-Center Study in Patients

TypeobservationalSponsorChina National Center for Cardiovascular DiseasesRan2024 to 2025Enrolled100ConditionsCoronary Artery Disease, Coronary Stenosis, Algorithm Validation for Fractional Flow Reserve Derived From Intravascular UltrasoundArmsNo Intervention (Retrospective Data Analysis)
NCT07577518 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Percutaneous Intervention Versus Optimal Medical Therapy in Chronic Coronary Syndrome (PIVOT) Trial

TypeinterventionalSponsorSeoul National University HospitalRan2026 to 2034Enrolled2,301ConditionsChronic Coronary SyndromeArmspercutaneous coronary intervention, Guideline-directed Optimal Medical treatment, Carvedilol Sustained-Release (SR) (Nested RCT subset), Carvedilol Immediate-Release (IR) (Nested RCT subset)
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 1 synthesis or guideline pooled it, 206 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Body weight rather than unfractionated heparin dose predicts periprocedural bleeding during elective PCI.International journal of cardiology. Cardiovascular risk and prevention · 2026
    Article
  5. Review
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  12. Automated stenosis estimation of coronary angiographies using end-to-end learning.The international journal of cardiovascular imaging · 2025
    Article
  13. The evaluation of combined fractional flow reserve and dynamic SPECT in chronic total occlusion.American heart journal plus : cardiology research and practice · 2024
    Article
  14. Article
  15. Review
  16. Article
  17. Noninvasive Coronary Physiological Assessment Derived From Computed Tomography.Journal of the Society for Cardiovascular Angiography & Interventions · 2024
    Review
  18. Article
  19. Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 16 institutions in 9 countries.

Frederik M ZimmermannDepartment of Cardiology, Catharina Hospital, Michelangelolaan 2, EJ Eindhoven, The Netherlands.
Elmir OmerovicDepartment of Cardiology, Sahlgrenska University Hospital, Blå stråket 5, Gothenburg, Sweden.
Stephane FournierCardiovascular Center Aalst, OLV-Clinic, Moorselbaan, Aalst, Belgium.
Henning KelbækDepartment of Cardiology, Zealand University Hospital, Sygehusvej 10, Roskilde, Denmark.
Nils P JohnsonDivision of Cardiology, Department of Medicine, Weatherhead PET Center, McGovern Medical School, UTHealth and Memorial Hermann Hospital, Fannin Street, Houston, TX, USA.
Martina RothenbühlerClinical Trials Unit, University of Bern, Mittelstrasse 43, Bern, Switzerland.
Panagiotis XaplanterisCardiovascular Center Aalst, OLV-Clinic, Moorselbaan, Aalst, Belgium.
Mohamed Abdel-WahabDepartment of Cardiology, Heart Center, Segeberger Am Kurpark 1, Bad Segeberg, Germany.
Emanuele BarbatoCardiovascular Center Aalst, OLV-Clinic, Moorselbaan, Aalst, Belgium.
Dan Eik HøfstenDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, Copenhagen, Denmark.
Pim A L ToninoDepartment of Cardiology, Catharina Hospital, Michelangelolaan 2, EJ Eindhoven, The Netherlands.
Bianca M Boxma-de KlerkDepartment of Cardiology, Maasstad Ziekenhuis, Maasstadweg 21, DZ Rotterdam, The Netherlands.
William F FearonDivision of Cardiovascular Medicine, Stanford University, Stanford, CA, USA.
Lars KøberDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, Copenhagen, Denmark.
Pieter C SmitsDepartment of Cardiology, Maasstad Ziekenhuis, Maasstadweg 21, DZ Rotterdam, The Netherlands.
Bernard De BruyneCardiovascular Center Aalst, OLV-Clinic, Moorselbaan, Aalst, Belgium.
Nico H J PijlsDepartment of Cardiology, Catharina Hospital, Michelangelolaan 2, EJ Eindhoven, The Netherlands.
Peter JüniApplied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Cir, Toronto, Ontario, Canada.
Thomas EngstrømDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, Copenhagen, Denmark.
Maasstad Ziekenhuis · NLOnze Lieve Vrouwziekenhuis Hospital · BERigshospitalet · DKCatharina Ziekenhuis · NLEindhoven University of Technology · NLLund University · SERadboud University Nijmegen · NLSahlgrenska University Hospital · SESegeberger Kliniken · DEStanford University · USSt. Michael's Hospital · CAThe University of Texas Health Science Center at Houston · USUniversity of Bern · CHUniversity of Lausanne · CHUniversity of Naples Federico II · ITZealand University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aims: To assess the effect of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) with contemporary drug-eluting stents on the composite of cardiac death or myocardial infarction (MI) vs. medical therapy in patients with stable coronary lesions. Methods and results: We performed a systematic review and meta-analysis of individual patient data (IPD) of the three available randomized trials of contemporary FFR-guided PCI vs. medical therapy for patients with stable coronary lesions: FAME 2 (NCT01132495), DANAMI-3-PRIMULTI (NCT01960933), and Compare-Acute (NCT01399736). FAME 2 enrolled patients with stable coronary artery disease (CAD), while the other two focused on non-culprit lesions in stabilized patients after acute coronary syndrome. A total of 2400 subjects were recruited from 54 sites world-wide with 1056 randomly assigned to FFR-guided PCI and 1344 to medical therapy. The pre-specified primary outcome was a composite of cardiac death or MI. We included data from extended follow-ups for FAME 2 (up to 5.5 years follow-up) and DANAMI-3-PRIMULTI (up to 4.7 years follow-up). After a median follow-up of 35 months (interquartile range 12-60 months), a reduction in the composite of cardiac death or MI was observed with FFR-guided PCI as compared with medical therapy (hazard ratio 0.72, 95% confidence interval 0.54-0.96; P = 0.02). The difference between groups was driven by MI. Conclusion: In this IPD meta-analysis of the three available randomized controlled trials to date, FFR-guided PCI resulted in a reduction of the composite of cardiac death or MI compared with medical therapy, which was driven by a decreased risk of MI.

Indexed as

Coronary Artery DiseasePercutaneous Coronary InterventionFemaleFractional Flow Reserve, MyocardialHumansMaleMiddle AgedMyocardial InfarctionPrognosisRandomized Controlled Trials as Topic

Identifiers

PMID30596995
PMCPMC6321954
OpenAlexW2906838549

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 1 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 Socratic graph.