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Randomized Controlled Trial
. 2025 Jan;18(1):e014610.
doi: 10.1161/CIRCINTERVENTIONS.124.014610. Epub 2024 Dec 27.

Impact of Bifurcation Lesions on Outcomes After FFR-Guided PCI or CABG

Daimy M M Dillen  1 , Hisao Otsuki  2 , Kuniaki Takahashi  2 , Yuhei Kobayashi  3 , Zsolt Piroth  4 , Nicolas Noiseux  5 , Badih El Nakadi  6 , Gintaras Kalinauskas  7 , Laszlo Szekely  8 , Giedrius Davidavičius  9 , Koen Teeuwen  1 , Pim A L Tonino  1   10 , Nico H J Pijls  1 , Bernard De Bruyne  11 , William F Fearon  2 , Frederik M Zimmermann  1   12
Affiliations
Randomized Controlled Trial

Impact of Bifurcation Lesions on Outcomes After FFR-Guided PCI or CABG

Daimy M M Dillen et al. Circ Cardiovasc Interv. 2025 Jan.

Abstract

Background: In the era of first-generation drug-eluting stents and angiography-guided percutaneous coronary intervention (PCI), the presence of a bifurcation lesion was associated with adverse outcomes after PCI. In contrast, the presence of a bifurcation lesion had no impact on outcomes following coronary artery bypass grafting (CABG). Therefore, the presence of a coronary bifurcation lesion requires special attention when choosing between CABG and PCI. The aim of this study is to assess whether the presence of a bifurcation lesion still influences clinical outcomes after contemporary PCI using second-generation drug-eluting stent and fractional flow reserve (FFR) guidance versus CABG.

Methods: The randomized FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) compared FFR-guided PCI using current drug-eluting stents with CABG in patients with 3-vessel coronary artery disease. The prespecified key end point at 3-year follow-up was the composite of death, myocardial infarction, or stroke. In this substudy, the impact of bifurcation lesions on outcomes after FFR-guided PCI and CABG was investigated.

Results: The FAME 3 trial enrolled 1500 patients and 653 (45.2%) patients had at least 1 true bifurcation lesion. There was no difference in the composite of death, myocardial infarction, or stroke at the 3-year follow-up between patients with or without at least 1 true bifurcation lesion (11.6% versus 10.0%; hazard ratio, 1.17 [95% CI, 0.86-1.61]; P=0.32), regardless of revascularization strategy. The composite end point was not statistically different between FFR-guided PCI and CABG in patients with at least 1 true bifurcation lesion (hazard ratio, 1.27 [95% CI, 0.80-2.00]) or without a true bifurcation lesion (hazard ratio, 1.36 [95% CI, 0.87-2.12]), with no significant interaction (Pinteraction=0.81).

Conclusions: In patients with 3-vessel coronary artery disease, the presence of a true bifurcation lesion was not associated with a different treatment effect after FFR-guided PCI with contemporary drug-eluting stent versus CABG.

Keywords: angiography; coronary artery bypass; drug-eluting stents; myocardial infarction; percutaneous coronary intervention; stroke.

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Conflict of interest statement

Dr Pijls received institutional research grants from Abbott, has consulting relationships with and receives fees from Abbott and Coroventis, holds equity in ASML, General Electric, HeartFlow, and Philips, is a member of the Scientific Advisory Board of HeartFlow, and has patents pending in the fields of coronary microcirculation and aortic valve stenosis. Dr Fearon received institutional research grants from Abbott and Medtronic, had consulting relationships in the past with CathWorks, and holds stock options in HeartFlow. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
Study flowchart. CABG indicates coronary artery bypass grafting; FAME, Fractional Flow Reserve Versus Angiography for Multivessel Evaluation; FFR, fractional flow reserve; and PCI, percutaneous coronary intervention.
Figure 2.
Figure 2.
Kaplan-Meier curves for the composite of death, myocardial infarction, or stroke between patients with and without ≥1 true bifurcation lesion. There is no significant difference in the composite of death, myocardial infarction, or stroke at 3-year follow-up between patients with and without at least 1 true bifurcation lesion. HR indicates hazard ratio.
Figure 3.
Figure 3.
Kaplan-Meier curves for the composite of death, myocardial infarction, or stroke between patients with and without ≥1 true bifurcation lesion according to assigned treatment strategy. There is no significant difference in the composite of death, myocardial infarction, or stroke at 3-year follow-up between patients with and without at least 1 true bifurcation lesion after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
See this image and copyright information in PMC

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