The Aftermath of a Negative Third FAME

Third FAME Trial

Authors

  • Dimitrios Oikonomou Evagelismos Hospital
  • Catherine Liontou Evagelismos Hospital
  • Konstantinos Triantafyllou Evagelismos Hospital

Abstract

The current guideline recommendations regarding myocardial revascularization of patients with multivessel coronary artery disease (CAD) mostly advocate coronary artery bypass grafting (CABG) over percutaneous coronary intervention (PCI), especially for patients with diabetes. However, in certain clinical cases, PCI can be considered. FAME and FAME 2 studies had demonstrated the superiority of fractional flow reserve (FFR)-guided PCI over angiography-guided PCI and over optimal medical therapy (OMT) alone respectively. FAME 3 study (Fractional Flow Reserve versus Angiography for Multivessel Evaluation), published early in 2022, was a study that investigated how PCI guided by FFR measurements can perform compared to CABG guided mostly by coronary angiography for the revascularization of patients with three-vessel CAD. Stable patients with an average SYNTAX score of 26 were randomized, while patients with left main disease, recent ST segment elevation myocardial infarction (STEMI), left ventricular ejection fraction <30% or cardiogenic shock were excluded. Regarding the composite primary endpoint of major adverse cardiovascular events (MACE), including death, non-fatal myocardial infarction, stroke or repeat revascularization, at 1 year follow-up, FFR-guided PCI failed to be proven as non-inferior compared to CABG. The findings of FAME 3 as added to those of FAME and FAME 2 should be considered in the context of current guidelines for myocardial revascularization and do not seem practice changing. Relevant limitations, possible implications and future perspectives are also briefly discussed herein. Rhythmos 2022;17(2): 32-35.

References

Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009;360:961-972.

Farkouh ME, Domanski M, Sleeper LA, et al. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 2012;367:2375-2384.

Authors/Task Force m, Windecker S, Kolh P, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014;35:2541-2619.

Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 2019;40:87-165.

Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213-224.

De Bruyne B, Pijls NH, Kalesan B, et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med 2012;367:991-1001.

van Nunen LX, Zimmermann FM, Tonino PA, et al. Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet 2015;386:1853-1860.

Fearon WF, Nishi T, De Bruyne B, et al. Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation 2018;137:480-487.

Fearon WF, Zimmermann FM, De Bruyne B, et al. Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery. N Engl J Med 2022;386:128-137.

Parikh RV, Liu G, Plomondon ME, et al. Utilization and Outcomes of Measuring Fractional Flow Reserve in Patients With Stable Ischemic Heart Disease. J Am Coll Cardiol 2020;75:409-419.

Puymirat E, Cayla G, Simon T, et al. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med 2021;385:297-308.

Rioufol G, Derimay F, Roubille F, et al. Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease. J Am Coll Cardiol 2021;78:1875-1885.

Thuesen AL, Riber LP, Veien KT, et al. Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting. J Am Coll Cardiol 2018;72:2732-2743.

Toth GG, De Bruyne B, Kala P, et al. Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial. EuroIntervention 2019;15:e999-e1005.

Zhang J, Gao X, Kan J, et al. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial. J Am Coll Cardiol 2018;72:3126-3137.

Escaned J, Collet C, Ryan N, et al. Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study. Eur Heart J 2017;38:3124-3134.

Gaudino M, Bakaeen FG, Benedetto U, et al. Arterial Grafts for Coronary Bypass: A Critical Review After the Publication of ART and RADIAL. Circulation 2019;140:1273-1284.

Downloads

Published

2022-04-04 — Updated on 2022-04-09

Versions

Issue

Section

Review