The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone

Barbato, Emanuele

Curzen, Nick

De Bruyne, Bernard

Engström, Thomas

FAME 2, Trial Investigators

Fearon, William F

Frobert, Ole

Jagic, Nikola

Johnson, Jane B

Jüni, Peter

Kala, Petr

Kalesan, Bindu

MacCarthy, Philip

Manoharan, Ganesh

Mavromatis, Kreton

Möbius-Winkler, Sven

Oldroyd, Keith G

Pijls, Nico H J

Piroth, Zsolt

Rioufol, Gilles

Tonino, Pim A L

Verlee, Peter

Witt, Nils

New England Journal of Medicine

BACKGROUNDThe preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone.METHODSIn patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.RESULTSRecruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P&lt;0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P&lt;0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P&lt;0.001). Among patients in the registry, 3.0% had a primary end-point event.CONCLUSIONSIn patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.

Mobius-Winckler, Sven

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King's Research Portal

Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease

Bernard De Bruyne

Nico H.J. Pijls

Bindu Kalesan

Emanuele Barbato

Pim A.L. Tonino

Zsolt Piroth

Nikola Jagic

Sven Möbius-Winkler

Gilles Rioufol

Nils Witt

Petr Kala

Philip MacCarthy

Thomas Engström

Keith G. Oldroyd

Kreton Mavromatis

Ganesh Manoharan

Peter Verlee

Ole Frobert

Nick Curzen

Jane B. Johnson

Peter Jüni

William F. Fearon

Crossref

Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease

de Bruyne, B.

Pijls, N.H.J..

Kalesan, B.

Barbato, E.

Tonino, P.

Piroth, Z.

Jagic, N.

Mobius-Winckler, S.

Rioufol, G.

Witt, N.

Kala, P.

MacCarthy, P.A.

Engstrøm, T.

Oldroyd, K.G.

Mavromatis, K.

Manoharan, G.

Verlee, P.

Frøbert, O.

Curzen, N.

Johnson, J.B.

Jueni, P.

Fearon, W.F.

NARCIS 

Bern Open Repository and Information System (BORIS)

Bruyne, Bernard  De

Pijls, NHJ Nico

Kalesan, B Bindu

Barbato, E

Tonino, PAL (Pim)

Piroth, Z Zsolt

Jagic, N Nikola

Mobius-Winckler, S Sven

Rioufol, Gilles Gilles

Witt, Nils Nils

Kala, Petr Petr

MacCarthy, PA

Engstrøm, T (Thomas)

Mavromatis, K Kreton

Manoharan, G

Verlee, P Peter

Frøbert, O

Curzen, N Nick

Johnson, JB Jane

Jueni, P Peter

Repository TU/e

BACKGROUND: The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone.



METHODS: In patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.



RESULTS: Recruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P&#60;0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P&#60;0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P&#60;0.001). Among patients in the registry, 3.0% had a primary end-point event.



CONCLUSIONS: In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone

De Bruyne, B.

Pijls, N.H.J.

Tonino, P.A.L.

Möbius-Winkler, S.

MacCarthy, P.

Engström, T.

Frobert, O.

Jüni, P.

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Fractional flow reserve–guided PCI versus medical therapy in stable coronary disease

Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease

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