The University of Southampton
University of Southampton Institutional Repository

Five-year outcomes with PCI guided by fractional flow reserve

Five-year outcomes with PCI guided by fractional flow reserve
Five-year outcomes with PCI guided by fractional flow reserve

Background: we hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease.

Methods: among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.

Results: a total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval [CI], 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy.

Conclusions: in patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495 .).

Aged, Angina Pectoris/therapy, Antihypertensive Agents/therapeutic use, Coronary Disease/drug therapy, Coronary Stenosis/drug therapy, Drug-Eluting Stents, Female, Follow-Up Studies, Fractional Flow Reserve, Myocardial, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction/epidemiology, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors/therapeutic use, Retreatment/statistics & numerical data
0028-4793
250-259
Xaplanteris, Panagiotis
6901700d-6ac8-41b6-8e63-2768d38789b1
Fournier, Stephane
b92de86c-fd9d-48df-a9a1-249d34bdd6ac
Pijls, Nico H J
90717d6e-0756-4d55-ba7f-d4f7377ea048
Fearon, William F
0cd8b847-758f-4501-bd76-543e630f3179
Barbato, Emanuele
50106486-a9cd-4c08-9ee7-74d049a9356d
Tonino, Pim A L
f22d79b3-5ee7-4780-b25c-df728ce09a3b
Engstrøm, Thomas
ac797dfe-9ad1-4aca-a7d5-53b13b4422de
Kääb, Stefan
03ae2a2c-1e5f-4de8-b9e7-95bd559fc07a
Dambrink, Jan-Henk
2c962bf2-b825-4891-a3b6-b84fa6aa8ab1
Rioufol, Gilles
87163c97-9ed4-477a-9692-6ac8506fcd9f
Toth, Gabor G
af8702a6-1b7d-4eea-92d0-39e3c3dce06a
Piroth, Zsolt
987ac008-d51d-4a12-a67c-499766e2fba5
Witt, Nils
36920472-6c35-4858-916e-040dbc5e29ce
Fröbert, Ole
6ed61821-ddc6-4acc-ba71-888007209070
Kala, Petr
7f4cfffe-5789-46ab-8a22-eb77a078f3f2
Linke, Axel
f5304b6d-2bb4-4a87-88aa-ff1d1e71d529
Jagic, Nicola
0669a4c7-22be-40d1-aacd-1822a34ea175
Mates, Martin
f784eee6-230f-480c-80f6-f1275c0e454a
Mavromatis, Kreton
f5504621-1e1a-425f-a3ce-4e68d697dffb
Samady, Habib
3de77cd5-a7ae-4456-8306-6ab968976e84
Irimpen, Anand
1423e29e-5bc8-44f0-acfc-41320527c14c
Oldroyd, Keith
c14c5917-9f7f-46b6-852b-9163add073f7
Campo, Gianluca
56959271-26a6-44d1-9aed-feedaf093b96
Rothenbühler, Martina
be1f8700-d113-465b-bfbc-b2a5d919157d
Jüni, Peter
1448ad34-a0d4-4faa-962b-abf202246167
De Bruyne, Bernard
6c86ad29-d853-4e59-9633-f536a17efd4e
Curzen, Nicholas
70f3ea49-51b1-418f-8e56-8210aef1abf4
FAME 2 Investigators
Xaplanteris, Panagiotis
6901700d-6ac8-41b6-8e63-2768d38789b1
Fournier, Stephane
b92de86c-fd9d-48df-a9a1-249d34bdd6ac
Pijls, Nico H J
90717d6e-0756-4d55-ba7f-d4f7377ea048
Fearon, William F
0cd8b847-758f-4501-bd76-543e630f3179
Barbato, Emanuele
50106486-a9cd-4c08-9ee7-74d049a9356d
Tonino, Pim A L
f22d79b3-5ee7-4780-b25c-df728ce09a3b
Engstrøm, Thomas
ac797dfe-9ad1-4aca-a7d5-53b13b4422de
Kääb, Stefan
03ae2a2c-1e5f-4de8-b9e7-95bd559fc07a
Dambrink, Jan-Henk
2c962bf2-b825-4891-a3b6-b84fa6aa8ab1
Rioufol, Gilles
87163c97-9ed4-477a-9692-6ac8506fcd9f
Toth, Gabor G
af8702a6-1b7d-4eea-92d0-39e3c3dce06a
Piroth, Zsolt
987ac008-d51d-4a12-a67c-499766e2fba5
Witt, Nils
36920472-6c35-4858-916e-040dbc5e29ce
Fröbert, Ole
6ed61821-ddc6-4acc-ba71-888007209070
Kala, Petr
7f4cfffe-5789-46ab-8a22-eb77a078f3f2
Linke, Axel
f5304b6d-2bb4-4a87-88aa-ff1d1e71d529
Jagic, Nicola
0669a4c7-22be-40d1-aacd-1822a34ea175
Mates, Martin
f784eee6-230f-480c-80f6-f1275c0e454a
Mavromatis, Kreton
f5504621-1e1a-425f-a3ce-4e68d697dffb
Samady, Habib
3de77cd5-a7ae-4456-8306-6ab968976e84
Irimpen, Anand
1423e29e-5bc8-44f0-acfc-41320527c14c
Oldroyd, Keith
c14c5917-9f7f-46b6-852b-9163add073f7
Campo, Gianluca
56959271-26a6-44d1-9aed-feedaf093b96
Rothenbühler, Martina
be1f8700-d113-465b-bfbc-b2a5d919157d
Jüni, Peter
1448ad34-a0d4-4faa-962b-abf202246167
De Bruyne, Bernard
6c86ad29-d853-4e59-9633-f536a17efd4e
Curzen, Nicholas
70f3ea49-51b1-418f-8e56-8210aef1abf4

Curzen, Nicholas , FAME 2 Investigators (2018) Five-year outcomes with PCI guided by fractional flow reserve. New England Journal of Medicine, 379 (3), 250-259. (doi:10.1056/NEJMoa1803538).

Record type: Article

Abstract

Background: we hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease.

Methods: among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.

Results: a total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval [CI], 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy.

Conclusions: in patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495 .).

Text
Five­Year Outcomes with PCI Guided - Version of Record
Available under License Other.
Download (388kB)

More information

e-pub ahead of print date: 22 May 2018
Published date: 19 July 2018
Keywords: Aged, Angina Pectoris/therapy, Antihypertensive Agents/therapeutic use, Coronary Disease/drug therapy, Coronary Stenosis/drug therapy, Drug-Eluting Stents, Female, Follow-Up Studies, Fractional Flow Reserve, Myocardial, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction/epidemiology, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors/therapeutic use, Retreatment/statistics & numerical data

Identifiers

Local EPrints ID: 442650
URI: http://eprints.soton.ac.uk/id/eprint/442650
ISSN: 0028-4793
PURE UUID: 2c752cbb-b5ab-4ac0-a1d6-eec812c8fcbe
ORCID for Nicholas Curzen: ORCID iD orcid.org/0000-0001-9651-7829

Catalogue record

Date deposited: 22 Jul 2020 16:31
Last modified: 17 Mar 2024 03:02

Export record

Altmetrics

Contributors

Author: Panagiotis Xaplanteris
Author: Stephane Fournier
Author: Nico H J Pijls
Author: William F Fearon
Author: Emanuele Barbato
Author: Pim A L Tonino
Author: Thomas Engstrøm
Author: Stefan Kääb
Author: Jan-Henk Dambrink
Author: Gilles Rioufol
Author: Gabor G Toth
Author: Zsolt Piroth
Author: Nils Witt
Author: Ole Fröbert
Author: Petr Kala
Author: Axel Linke
Author: Nicola Jagic
Author: Martin Mates
Author: Kreton Mavromatis
Author: Habib Samady
Author: Anand Irimpen
Author: Keith Oldroyd
Author: Gianluca Campo
Author: Martina Rothenbühler
Author: Peter Jüni
Author: Bernard De Bruyne
Author: Nicholas Curzen ORCID iD
Corporate Author: FAME 2 Investigators

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×