Article Synopsis
- The FAME 3 trial analyzed the long-term effectiveness of FFR-guided PCI versus CABG in patients with three-vessel coronary artery disease over a 5-year period, involving multiple hospitals across Europe, the USA, Canada, Australia, and Asia.
- Results showed no significant differences in major adverse outcomes (death, stroke, or myocardial infarction) between the PCI and CABG groups, with 16% of PCI patients and 14% of CABG patients experiencing these events by the end of the study.
- The trial's findings indicate that both treatment options have similar long-term outcomes, as the rates of death and other complications were comparable for both techniques, suggesting that advancements in care did not
Video Abstracts
Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Background: Long-term outcomes following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) might be changing because of improved techniques and better medical therapy. This final prespecified analysis of the Fractional Flow Reserve (FFR) versus Angiography for Multivessel Evaluation (FAME) 3 trial aimed to reassess their comparative effectiveness at 5 years.
Methods: FAME 3 was a multicentre, randomised trial comparing FFR-guided PCI using current-generation zotarolimus-eluting stents versus CABG in patients with three-vessel coronary artery disease not involving the left main coronary artery. 48 hospitals in Europe, USA and Canada, Australia, and Asia participated in the trial. Patients (aged ≥21 years with no cardiogenic shock, no recent ST segment elevation myocardial infarction, no severe left ventricular dysfunction, and no previous CABG) were randomly assigned to either PCI or CABG using a web-based system. At 1 year, FFR-guided PCI did not meet the prespecified threshold for non-inferiority for the outcome of death, stroke, myocardial infarction, or repeat revascularisation versus CABG. The primary endpoint for this intention-to-treat analysis was the 5-year incidence of the prespecified composite outcome of death, stroke, or myocardial infarction. The trial was registered at ClinicalTrials.gov, NCT02100722, and is completed; this is the final report.
Findings: Between Aug 25, 2014 and Nov 28, 2019, 757 of 1500 participants were assigned to PCI and 743 to CABG. 5-year follow-up was achieved in 724 (96%) patients assigned to PCI and 696 (94%) assigned to CABG. At 5 years, there was no significant difference in the composite of death, stroke, or myocardial infarction between the two groups, with 119 (16%) events in the PCI group and 101 (14%) in the CABG group (hazard ratio 1·16 [95% CI 0·89-1·52]; p=0·27). There were no differences in the rates of death (53 [7%] vs 51 [7%]; 0·99 [0·67-1·46]) or stroke (14 [2%] vs 21 [3%], 0·65 [0·33-1·28]), but myocardial infarction was higher in the PCI group than in the CABG group (60 [8%] vs 38 [5%], 1·57 [1·04-2·36]), as was repeat revascularisation (112 [16%] vs 55 [8%], 2·02 [1·46-2·79]).
Interpretation: At the 5-year follow-up, there was no significant difference in a composite outcome of death, stroke, or myocardial infarction after FFR-guided PCI versus CABG, although myocardial infarction and repeat revascularisation were higher with PCI. These results provide contemporary evidence to allow improved shared decision making between physicians and patients.
Funding: Medtronic and Abbott Vascular.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/S0140-6736(25)00505-7 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Occupational exposure to chemicals and particles and incidence of myocardial infarction-a nationwide cohort study in Sweden.
Environ Res
September 2025
Institute of Environmental Medicine, Karolinska Institutet, Solnavägen 4, SE-113 65 Stockholm, SWEDEN.
Cardiovascular disease (CVD) is the leading cause of death in Europe, with myocardial infarction (MI) being one of its most severe manifestations. While many risk factors for CVD are well known, occupational exposures remain relatively understudied-especially in analyses that adjust for co-occurring workplace exposures. This study aimed to examine the association between occupational exposure to chemicals and particles and the risk of first-time MI.
View Article and Find Full Text PDFLong-term Exposure to PM Components and Cardiovascular Admissions in Medicare Patients.
Environ Res
September 2025
Department of Environmental Health, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.
Background: Fine particulate matter (PM) has been previously linked to cardiovascular diseases (CVDs). PM is a mixture of components, each of which has its own toxicity profile which are not yet well understood. This study explores the relationship between long-term exposure to PM components and hospital admissions with CVDs in the Medicare population.
View Article and Find Full Text PDFExposure to high levels of perfluoroalkyl substances through drinking water and risk of cardiovascular morbidity and mortality in a Swedish register-based study.
Environ Res
September 2025
School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Electronic address:
Introduction: Epidemiological studies focusing on the association of exposure to perfluoroalkyl substances (PFAS) with cardiovascular disease (CVD) morbidity and mortality are limited, with inconsistent findings.
Objectives: This register-based study aimed to investigate the associations between exposure to PFAS and the risk of CVD morbidity and mortality in a Swedish population exposed to PFAS, dominated by perfluorohexane sulfonic acid (PFHxS) and perfluorooctane sulfonic acid (PFOS), through drinking water for decades.
Methods: The study included 46 553 individuals aged ≥30 who lived in Ronneby (1985-2013).
Recent advances in intelligent oxygen delivery systems for tissue regeneration.
Adv Drug Deliv Rev
September 2025
State Key Laboratory of Pharmaceutical Biotechnology, Medical School, Nanjing University, Nanjing 210093, China; Department of Pharmacy, The Air Force Hospital of Eastern Theater Command, Nanjing 210002, China; Jiangsu Provincial Key Laboratory of Nano Technology, Medical School, Nanjing University,
Oxygen plays a critical regulatory role in tissue repair and regeneration. However, in the microenvironment of tissues with vascular damage, hypoxia is commonly present. This not only suppresses cell proliferation and differentiation but also delays angiogenesis and extracellular matrix reconstruction, ultimately hindering the tissue regeneration process.
View Article and Find Full Text PDFAdverse events associated with COVID-19 vaccination or diagnosis among pregnant and non-pregnant women in the United States, 2021-2022.
Int J Infect Dis
September 2025
University of San Francisco, Department of Nursing and Health Professions, San Francisco, California, United States; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; Department of Epidemiology, Fielding School of Public Health, University of California, Los A
Objectives: To quantify the incidence of adverse events given COVID-19 vaccination and COVID-19 diagnosis in women of reproductive age; to examine pregnancy as a potential risk modifier.
Methods: An exposure-matched cohort study of >1 million women, 11 December 2020-30 September 2022, United States. COVID-19 vaccination, COVID-19 diagnoses, and medically-attended adverse events - including immunologic, neurologic, cerebrovascular, thromboembolic, cardiovascular, respiratory, thrombocytopenic and coagulative events - were identified from inpatient and outpatient medical claims.