TY - JOUR

T1 - Five-Year Outcomes with PCI Guided by Fractional Flow Reserve

AU - Xaplanteris, Panagiotis

AU - Fournier, Stephane

AU - Pijls, Nico H J

AU - Fearon, William F

AU - Barbato, Emanuele

AU - Tonino, Pim A L

AU - Engstrøm, Thomas

AU - Kääb, Stefan

AU - Dambrink, Jan-Henk

AU - Rioufol, Gilles

AU - Toth, Gabor G

AU - Piroth, Zsolt

AU - Witt, Nils

AU - Fröbert, Ole

AU - Kala, Petr

AU - Linke, Axel

AU - Jagic, Nicola

AU - Mates, Martin

AU - Mavromatis, Kreton

AU - Samady, Habib

AU - Irimpen, Anand

AU - Oldroyd, Keith

AU - Campo, Gianluca

AU - Rothenbühler, Martina

AU - Jüni, Peter

AU - De Bruyne, Bernard

AU - FAME 2 Investigators

PY - 2018

Y1 - 2018

N2 - 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 .).

AB - 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 .).

KW - Aged

KW - Angina Pectoris/therapy

KW - Antihypertensive Agents/therapeutic use

KW - Coronary Disease/drug therapy

KW - Coronary Stenosis/drug therapy

KW - Drug-Eluting Stents

KW - Female

KW - Follow-Up Studies

KW - Fractional Flow Reserve, Myocardial

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Myocardial Infarction/epidemiology

KW - Percutaneous Coronary Intervention

KW - Platelet Aggregation Inhibitors/therapeutic use

KW - Retreatment/statistics & numerical data

U2 - 10.1056/NEJMoa1803538

DO - 10.1056/NEJMoa1803538

M3 - Journal article

C2 - 29785878

VL - 379

SP - 250

EP - 259

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 3

ER -