Five-Year Outcomes with PCI Guided by Fractional Flow Reserve.
Details
Serval ID
serval:BIB_21462656CE08
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Five-Year Outcomes with PCI Guided by Fractional Flow Reserve.
Journal
The New England journal of medicine
Working group(s)
FAME 2 Investigators
Contributor(s)
Jüni P., Lonn U., Kern M.J., Mahmud E., Lim M., Windecker S., Gersh B.J., Pocock S.J., Brinton T., Lee D., Carroll T., Daniels D., Giacomini J., Trammel J., Yeung A., Ver Lee P., Crespo G., Fincke R., McKay M., Rowe M., Vom Eigen P., Wiseman A., Block P., Kumar G., Babaliaros V., Douglas J., McDaniel M., Morris D., Sperling L., Tanveer Rab S., Arain S., Schampaert E., Mansour S., Gobeil F., Kokis A., Lemire F., Pilon C., MacCarthy P., Byrne J., Melikian N., Curzen N., Calver A., Gray H., Manoharan G., Etieba H., Lindsay M., Uren N., Cruden N., Henriksen P., Sohn H., Leibig M., Möbius-Winkler S., Rieber J., Deichstetter M., de lo Fuente S., Tonino P., Wijnbergen I., Willem Sels J., Rensing BJWM, Mulder BJM, van den Akker A.N., Jerabek P., Neugebauer P., Korvicek P., Alstrom P., Bartunek J., Heyndrickx G., Van Mieghem C., Wijns W., Vanderheyden M., Wyffels E., Vandriessche L., Heyse A., Jorgensen E., Kelbaek H., Finet G., Andréka P., Fontos G., Tóth G., Valgimigli M., Tumscitt C., Miloradovic V., Nikolic D., Stefanini G., Pilgrim T., Stortecky S., Pellicano M., Ciccarelli G.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
19/07/2018
Peer-reviewed
Oui
Volume
379
Number
3
Pages
250-259
Language
english
Notes
Publication types: Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
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.
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.
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.
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 .).
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.
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.
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 .).
Keywords
Aged, Angina Pectoris/therapy, Antihypertensive Agents/therapeutic use, Coronary Disease/drug therapy, Coronary Disease/mortality, Coronary Disease/therapy, Coronary Stenosis/drug therapy, Coronary Stenosis/physiopathology, Coronary Stenosis/therapy, Drug-Eluting Stents, Female, Follow-Up Studies, Fractional Flow Reserve, Myocardial, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction/epidemiology, Myocardial Infarction/prevention & control, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors/therapeutic use, Retreatment/statistics & numerical data
Pubmed
Web of science
Create date
26/08/2019 16:44
Last modification date
28/08/2019 5:26
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