Evidence map›Paper›PMID 41540107›Full record

Trial reportNature medicine2026

Fractional flow reserve-guided percutaneous coronary intervention versus medical therapy for stable coronary artery disease: long-term results of the FAME 2 trial.

Carlos Collet, Thabo Mahendiran, William F Fearon, Takuya Mizukami, Daniel Munhoz, Nico H J Pijls, Pim A L Tonino, Emanuele Barbato, Zsolt Piroth, Miodrag Sreckovic and 20 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06159231 (Fractional Flow Reserve-guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease - FAME II, a 10-year Follow-up Study.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06159231 completednot 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 - FAME II, a 10-year Follow-up Study.

TypeobservationalSponsorCoreAalst BVRan2023 to 2024Enrolled888ConditionsCoronary Artery Disease
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

30 authors.

Carlos Collet *Cardiovascular Center Aalst, AZORG, Aalst, Belgium.
Thabo Mahendiran *Cardiovascular Center Aalst, AZORG, Aalst, Belgium.ORCID 0000-0002-0025-8162
William F FearonDivision of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine and VA Palo Alto Health Care System, Palo Alto, CA, USA.
Takuya MizukamiCardiovascular Center Aalst, AZORG, Aalst, Belgium.
Daniel MunhozCardiovascular Center Aalst, AZORG, Aalst, Belgium.
Nico H J PijlsDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Pim A L ToninoDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Emanuele BarbatoDepartment of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.
Zsolt PirothGottsegen National Cardiovascular Center, Budapest, Hungary.ORCID 0000-0001-9256-1267
Miodrag SreckovicDepartment of Internal Medicine, University of Kragujevac, Kragujevac, Serbia.
Holger ThieleHeart Center Leipzig at University of Leipzig, Leipzig, Germany.ORCID 0000-0002-0169-998X
Mohamed El FarissiDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Nils WittDepartment of Clinical Science and Education, Unit of Cardiology, Karolinska Institute, Södersjukhuset, Stockholm, Sweden.
Gilles RioufolHospices Civils de Lyon and Claude Bernard University, Lyon, France.
Petr KalaMedical Faculty of Masaryk University and University Hospital Brno, Brno, Czech Republic.
Thomas EngstrømRigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Kreton MavromatisAtlanta VA Medical Center, Emory University, Atlanta, GA, USA.
Ole FröbertDepartment of Cardiology, Örebro University Hospital, Örebro, Sweden.
Peter VerleeNortheast Cardiology Associates, Bangor, ME, USA.
Stefan BrunnerDepartment of Medicine I, University Hospital Munich, Ludwig Maximilian University of Munich (LMU), Munich, Germany.
Martin MatesNa Homolce Hospital, Prague, Czech Republic.
Nikola JagicClinical Hospital Center Zemun, Beograd, Serbia.
Gianluca CampoCardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.
Sofie PardaensCardiovascular Center Aalst, AZORG, Aalst, Belgium.
Kazumasa IkedaCardiovascular Center Aalst, AZORG, Aalst, Belgium.ORCID 0000-0002-1680-659X
Tiago Veiga PereiraClinical Trial Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Bruno R da CostaClinical Trial Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0002-1786-6332
Stephane FournierDepartment of Cardiology, Lausanne University Hospital, Lausanne, Switzerland.
Bernard De BruyneCardiovascular Center Aalst, AZORG, Aalst, Belgium. bernard.de.bruyne@azorg.be.ORCID 0000-0001-6567-168X
Peter JüniClinical Trial Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, Oxford, UK. peter.juni@ndph.ox.ac.uk.ORCID 0000-0002-5985-0670

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In patients with stable coronary artery disease (CAD), the long-term benefits of revascularization over medical therapy remain unclear. In the Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2 trial, patients with hemodynamically significant stenoses (fractional flow reserve (FFR) ≤ 0.80) were randomized to receive FFR-guided percutaneous coronary intervention (PCI) plus medical therapy (n = 447) or medical therapy alone (n = 441). At 5 years, FFR-guided PCI reduced the risk of the primary composite outcome of time to death, myocardial infarction or urgent revascularization, largely because of fewer urgent revascularizations. We now report the long-term clinical outcomes from this trial. Sixteen hospitals, contributing 748 randomized patients (161 women, 21.5%), participated in the long-term follow-up. The primary composite outcome was analyzed hierarchically using the unstratified win ratio, which addressed differential missingness of data on nonfatal outcomes in deceased patients by prioritizing comparisons on time to death. At a median follow-up of 11.2 years, the primary endpoint occurred in 150 of 447 patients (33.6%) in the PCI group versus 182 of 441 (41.3%) in the medical therapy group. PCI was superior in 29.2% of comparisons, medical therapy in 23.3%, and the two groups were tied in 47.5%, resulting in a win ratio of 1.25 in favor of PCI (95% confidence interval (CI) 1.01-1.56, P = 0.043). The corresponding win difference was 5.9% (95% CI 0.2-11.6), and the number needed to treat was 17 (95% CI 9-500). Win ratios were 0.88 for all-cause death (95% CI 0.66-1.17), 1.50 for myocardial infarction (95% CI 0.98-2.31) and 4.57 for urgent revascularization (95% CI 2.53-8.24). During long-term follow-up, FFR-guided PCI in patients with stable CAD and hemodynamically significant stenoses reduced the composite of death, myocardial infarction or urgent revascularization, primarily because of fewer urgent revascularizations. These long-term findings reaffirm the efficacy of FFR-guided PCI over medical therapy in patients with stable CAD. ClinicalTrials.gov registration: NCT06159231 .

Indexed as

Coronary Artery DiseaseFractional Flow Reserve, MyocardialPercutaneous Coronary InterventionAgedCoronary AngiographyFemaleFollow-Up StudiesHumansMaleMiddle AgedMyocardial InfarctionTreatment Outcome

Identifiers

What Socratic 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 Socratic graph.