Sex Differences in Patients Undergoing FFR-Guided PCI or CABG in the FAME 3 Trial

Kuniaki Takahashi; Hisao Otsuki; Frederik M. Zimmermann; Victoria Y. Ding; Keith G. Oldroyd; Olaf Wendler; Michael J. Reardon; Y. Joseph Woo; Alan C. Yeung; Nico H.J. Pijls; Bernard De Bruyne; William F. Fearon

doi:10.1016/j.jcin.2024.09.030

Sex Differences in Patients Undergoing FFR-Guided PCI or CABG in the FAME 3 Trial

Kuniaki Takahashi, Hisao Otsuki, Frederik M. Zimmermann, Victoria Y. Ding, Keith G. Oldroyd, Olaf Wendler, Michael J. Reardon, Y. Joseph Woo, Alan C. Yeung, Nico H.J. Pijls, Bernard De Bruyne, William F. Fearon

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

BACKGROUND: Outcomes in women after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using current-generation drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) are unknown.

OBJECTIVES: This study sought to evaluate differences in clinical outcomes according to sex after FFR-guided PCI with current generation DES compared with CABG.

METHODS: The FAME 3 (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) trial was an investigator-initiated, randomized controlled trial, comparing FFR-guided PCI with current generation DES or CABG in patients with 3-vessel coronary artery disease. This prespecified subgroup analysis compared the incidence of major adverse cardiac and cerebrovascular events (MACCE) according to sex, defined as the composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at 3 years.

RESULTS: Of 1,500 patients included in the FAME 3 trial, 265 (17.7%) were women. Women had a significantly higher risk of MACCE at 3 years compared with men after CABG (18.1% vs 11.7%; adjusted HR: 2.07; 95% CI: 1.19-3.60), whereas women had a similar risk of MACCE at 3 years compared with men after PCI (18.2% vs 19.1%; adjusted HR: 1.27; 95% CI: 0.79-2.03). Regarding treatment effects by sex, women undergoing PCI had a similar risk of MACCE at 3 years compared with CABG (adjusted HR: 1.15; 95% CI: 0.62-2.11). By contrast, men undergoing PCI had a higher risk of MACCE at 3 years compared with CABG (adjusted HR: 1.68; 95% CI: 1.25-2.25; P interaction = 0.142), which was mainly driven by a higher risk of myocardial infarction (adjusted HR: 2.11; 95% CI: 1.26-3.56; P interaction = 0.102) and repeat revascularization (adjusted HR: 2.26; 95% CI: 1.47-3.47; P interaction = 0.071).

CONCLUSIONS: In the FAME 3 trial, at 3 years, women had similar outcomes with FFR-guided PCI compared with CABG, whereas men had improved outcomes with CABG. (A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease [FAME 3]; NCT02100722).

Original language	English (US)
Pages (from-to)	157-167
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	18
Issue number	2
DOIs	https://doi.org/10.1016/j.jcin.2024.09.030
State	Published - Jan 27 2025

Keywords

coronary artery bypass grafting
fractional flow reserve
percutaneous coronary intervention
three-vessel coronary artery disease
Percutaneous Coronary Intervention/adverse effects
Predictive Value of Tests
Drug-Eluting Stents
Risk Assessment
Health Status Disparities
Humans
Middle Aged
Risk Factors
Male
Treatment Outcome
Coronary Artery Disease/diagnostic imaging
Coronary Angiography
Fractional Flow Reserve, Myocardial
Time Factors
Cardiac Catheterization/adverse effects
Progression-Free Survival
Sex Factors
Female
Aged
Coronary Artery Bypass/adverse effects

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jcin.2024.09.030

Cite this

@article{0460b84376bc4d2797439bff32e09c7d,

title = "Sex Differences in Patients Undergoing FFR-Guided PCI or CABG in the FAME 3 Trial",

abstract = "BACKGROUND: Outcomes in women after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using current-generation drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) are unknown.OBJECTIVES: This study sought to evaluate differences in clinical outcomes according to sex after FFR-guided PCI with current generation DES compared with CABG.METHODS: The FAME 3 (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) trial was an investigator-initiated, randomized controlled trial, comparing FFR-guided PCI with current generation DES or CABG in patients with 3-vessel coronary artery disease. This prespecified subgroup analysis compared the incidence of major adverse cardiac and cerebrovascular events (MACCE) according to sex, defined as the composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at 3 years.RESULTS: Of 1,500 patients included in the FAME 3 trial, 265 (17.7%) were women. Women had a significantly higher risk of MACCE at 3 years compared with men after CABG (18.1% vs 11.7%; adjusted HR: 2.07; 95% CI: 1.19-3.60), whereas women had a similar risk of MACCE at 3 years compared with men after PCI (18.2% vs 19.1%; adjusted HR: 1.27; 95% CI: 0.79-2.03). Regarding treatment effects by sex, women undergoing PCI had a similar risk of MACCE at 3 years compared with CABG (adjusted HR: 1.15; 95% CI: 0.62-2.11). By contrast, men undergoing PCI had a higher risk of MACCE at 3 years compared with CABG (adjusted HR: 1.68; 95% CI: 1.25-2.25; P interaction = 0.142), which was mainly driven by a higher risk of myocardial infarction (adjusted HR: 2.11; 95% CI: 1.26-3.56; P interaction = 0.102) and repeat revascularization (adjusted HR: 2.26; 95% CI: 1.47-3.47; P interaction = 0.071). CONCLUSIONS: In the FAME 3 trial, at 3 years, women had similar outcomes with FFR-guided PCI compared with CABG, whereas men had improved outcomes with CABG. (A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease [FAME 3]; NCT02100722).",

keywords = "coronary artery bypass grafting, fractional flow reserve, percutaneous coronary intervention, three-vessel coronary artery disease, Percutaneous Coronary Intervention/adverse effects, Predictive Value of Tests, Drug-Eluting Stents, Risk Assessment, Health Status Disparities, Humans, Middle Aged, Risk Factors, Male, Treatment Outcome, Coronary Artery Disease/diagnostic imaging, Coronary Angiography, Fractional Flow Reserve, Myocardial, Time Factors, Cardiac Catheterization/adverse effects, Progression-Free Survival, Sex Factors, Female, Aged, Coronary Artery Bypass/adverse effects",

author = "Kuniaki Takahashi and Hisao Otsuki and Zimmermann, {Frederik M.} and Ding, {Victoria Y.} and Oldroyd, {Keith G.} and Olaf Wendler and Reardon, {Michael J.} and Woo, {Y. Joseph} and Yeung, {Alan C.} and Pijls, {Nico H.J.} and {De Bruyne}, Bernard and Fearon, {William F.}",

year = "2025",

month = jan,

day = "27",

doi = "10.1016/j.jcin.2024.09.030",

language = "English (US)",

volume = "18",

pages = "157--167",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier",

number = "2",

}

TY - JOUR

T1 - Sex Differences in Patients Undergoing FFR-Guided PCI or CABG in the FAME 3 Trial

AU - Takahashi, Kuniaki

AU - Otsuki, Hisao

AU - Zimmermann, Frederik M.

AU - Ding, Victoria Y.

AU - Oldroyd, Keith G.

AU - Wendler, Olaf

AU - Reardon, Michael J.

AU - Woo, Y. Joseph

AU - Yeung, Alan C.

AU - Pijls, Nico H.J.

AU - De Bruyne, Bernard

AU - Fearon, William F.

PY - 2025/1/27

Y1 - 2025/1/27

N2 - BACKGROUND: Outcomes in women after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using current-generation drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) are unknown.OBJECTIVES: This study sought to evaluate differences in clinical outcomes according to sex after FFR-guided PCI with current generation DES compared with CABG.METHODS: The FAME 3 (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) trial was an investigator-initiated, randomized controlled trial, comparing FFR-guided PCI with current generation DES or CABG in patients with 3-vessel coronary artery disease. This prespecified subgroup analysis compared the incidence of major adverse cardiac and cerebrovascular events (MACCE) according to sex, defined as the composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at 3 years.RESULTS: Of 1,500 patients included in the FAME 3 trial, 265 (17.7%) were women. Women had a significantly higher risk of MACCE at 3 years compared with men after CABG (18.1% vs 11.7%; adjusted HR: 2.07; 95% CI: 1.19-3.60), whereas women had a similar risk of MACCE at 3 years compared with men after PCI (18.2% vs 19.1%; adjusted HR: 1.27; 95% CI: 0.79-2.03). Regarding treatment effects by sex, women undergoing PCI had a similar risk of MACCE at 3 years compared with CABG (adjusted HR: 1.15; 95% CI: 0.62-2.11). By contrast, men undergoing PCI had a higher risk of MACCE at 3 years compared with CABG (adjusted HR: 1.68; 95% CI: 1.25-2.25; P interaction = 0.142), which was mainly driven by a higher risk of myocardial infarction (adjusted HR: 2.11; 95% CI: 1.26-3.56; P interaction = 0.102) and repeat revascularization (adjusted HR: 2.26; 95% CI: 1.47-3.47; P interaction = 0.071). CONCLUSIONS: In the FAME 3 trial, at 3 years, women had similar outcomes with FFR-guided PCI compared with CABG, whereas men had improved outcomes with CABG. (A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease [FAME 3]; NCT02100722).

AB - BACKGROUND: Outcomes in women after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using current-generation drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) are unknown.OBJECTIVES: This study sought to evaluate differences in clinical outcomes according to sex after FFR-guided PCI with current generation DES compared with CABG.METHODS: The FAME 3 (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) trial was an investigator-initiated, randomized controlled trial, comparing FFR-guided PCI with current generation DES or CABG in patients with 3-vessel coronary artery disease. This prespecified subgroup analysis compared the incidence of major adverse cardiac and cerebrovascular events (MACCE) according to sex, defined as the composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at 3 years.RESULTS: Of 1,500 patients included in the FAME 3 trial, 265 (17.7%) were women. Women had a significantly higher risk of MACCE at 3 years compared with men after CABG (18.1% vs 11.7%; adjusted HR: 2.07; 95% CI: 1.19-3.60), whereas women had a similar risk of MACCE at 3 years compared with men after PCI (18.2% vs 19.1%; adjusted HR: 1.27; 95% CI: 0.79-2.03). Regarding treatment effects by sex, women undergoing PCI had a similar risk of MACCE at 3 years compared with CABG (adjusted HR: 1.15; 95% CI: 0.62-2.11). By contrast, men undergoing PCI had a higher risk of MACCE at 3 years compared with CABG (adjusted HR: 1.68; 95% CI: 1.25-2.25; P interaction = 0.142), which was mainly driven by a higher risk of myocardial infarction (adjusted HR: 2.11; 95% CI: 1.26-3.56; P interaction = 0.102) and repeat revascularization (adjusted HR: 2.26; 95% CI: 1.47-3.47; P interaction = 0.071). CONCLUSIONS: In the FAME 3 trial, at 3 years, women had similar outcomes with FFR-guided PCI compared with CABG, whereas men had improved outcomes with CABG. (A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease [FAME 3]; NCT02100722).

KW - coronary artery bypass grafting

KW - fractional flow reserve

KW - percutaneous coronary intervention

KW - three-vessel coronary artery disease

KW - Percutaneous Coronary Intervention/adverse effects

KW - Predictive Value of Tests

KW - Drug-Eluting Stents

KW - Risk Assessment

KW - Health Status Disparities

KW - Humans

KW - Middle Aged

KW - Risk Factors

KW - Male

KW - Treatment Outcome

KW - Coronary Artery Disease/diagnostic imaging

KW - Coronary Angiography

KW - Fractional Flow Reserve, Myocardial

KW - Time Factors

KW - Cardiac Catheterization/adverse effects

KW - Progression-Free Survival

KW - Sex Factors

KW - Female

KW - Aged

KW - Coronary Artery Bypass/adverse effects

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U2 - 10.1016/j.jcin.2024.09.030

DO - 10.1016/j.jcin.2024.09.030

M3 - Article

C2 - 39641725

AN - SCOPUS:85213540653

SN - 1936-8798

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JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 2

ER -

Sex Differences in Patients Undergoing FFR-Guided PCI or CABG in the FAME 3 Trial

Abstract

Keywords

ASJC Scopus subject areas

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