TY - JOUR
T1 - Fractional flow reserve-guided PCI for stable coronary artery disease
AU - De Bruyne, Bernard
AU - Fearon, William F
AU - Pijls, Nico H J
AU - Barbato, Emanuele
AU - Tonino, Pim
AU - Piroth, Zsolt
AU - Jagic, Nikola
AU - Mobius-Winckler, Sven
AU - Rioufol, Gilles
AU - Witt, Nils
AU - Kala, Petr
AU - MacCarthy, Philip
AU - Engström, Thomas
AU - Oldroyd, Keith
AU - Mavromatis, Kreton
AU - Manoharan, Ganesh
AU - Verlee, Peter
AU - Frobert, Ole
AU - Curzen, Nick
AU - Johnson, Jane B
AU - Limacher, Andreas
AU - Nüesch, Eveline
AU - Jüni, Peter
AU - FAME 2 Trial Investigators
PY - 2014/9/25
Y1 - 2014/9/25
N2 - BACKGROUND: We hypothesized that in patients with stable coronary artery disease and stenosis, percutaneous coronary intervention (PCI) performed on the basis of the fractional flow reserve (FFR) would be superior to medical therapy.METHODS: In 1220 patients with stable coronary artery disease, we assessed the FFR in all stenoses that were visible on angiography. Patients who had at least one stenosis with an FFR of 0.80 or less were randomly assigned to undergo FFR-guided PCI plus medical therapy or to receive medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy alone and were included in a registry. The primary end point was a composite of death from any cause, nonfatal myocardial infarction, or urgent revascularization within 2 years.RESULTS: The rate of the primary end point was significantly lower in the PCI group than in the medical-therapy group (8.1% vs. 19.5%; hazard ratio, 0.39; 95% confidence interval [CI], 0.26 to 0.57; P<0.001). This reduction was driven by a lower rate of urgent revascularization in the PCI group (4.0% vs. 16.3%; hazard ratio, 0.23; 95% CI, 0.14 to 0.38; P<0.001), with no significant between-group differences in the rates of death and myocardial infarction. Urgent revascularizations that were triggered by myocardial infarction or ischemic changes on electrocardiography were less frequent in the PCI group (3.4% vs. 7.0%, P=0.01). In a landmark analysis, the rate of death or myocardial infarction from 8 days to 2 years was lower in the PCI group than in the medical-therapy group (4.6% vs. 8.0%, P=0.04). Among registry patients, the rate of the primary end point was 9.0% at 2 years.CONCLUSIONS: In patients with stable coronary artery disease, FFR-guided PCI, as compared with medical therapy alone, improved the outcome. Patients without ischemia had a favorable outcome with medical therapy alone. (Funded by St. Jude Medical; FAME 2 ClinicalTrials.gov number, NCT01132495.).
AB - BACKGROUND: We hypothesized that in patients with stable coronary artery disease and stenosis, percutaneous coronary intervention (PCI) performed on the basis of the fractional flow reserve (FFR) would be superior to medical therapy.METHODS: In 1220 patients with stable coronary artery disease, we assessed the FFR in all stenoses that were visible on angiography. Patients who had at least one stenosis with an FFR of 0.80 or less were randomly assigned to undergo FFR-guided PCI plus medical therapy or to receive medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy alone and were included in a registry. The primary end point was a composite of death from any cause, nonfatal myocardial infarction, or urgent revascularization within 2 years.RESULTS: The rate of the primary end point was significantly lower in the PCI group than in the medical-therapy group (8.1% vs. 19.5%; hazard ratio, 0.39; 95% confidence interval [CI], 0.26 to 0.57; P<0.001). This reduction was driven by a lower rate of urgent revascularization in the PCI group (4.0% vs. 16.3%; hazard ratio, 0.23; 95% CI, 0.14 to 0.38; P<0.001), with no significant between-group differences in the rates of death and myocardial infarction. Urgent revascularizations that were triggered by myocardial infarction or ischemic changes on electrocardiography were less frequent in the PCI group (3.4% vs. 7.0%, P=0.01). In a landmark analysis, the rate of death or myocardial infarction from 8 days to 2 years was lower in the PCI group than in the medical-therapy group (4.6% vs. 8.0%, P=0.04). Among registry patients, the rate of the primary end point was 9.0% at 2 years.CONCLUSIONS: In patients with stable coronary artery disease, FFR-guided PCI, as compared with medical therapy alone, improved the outcome. Patients without ischemia had a favorable outcome with medical therapy alone. (Funded by St. Jude Medical; FAME 2 ClinicalTrials.gov number, NCT01132495.).
KW - Adrenergic beta-Antagonists
KW - Angiotensin Receptor Antagonists
KW - Angiotensin-Converting Enzyme Inhibitors
KW - Combined Modality Therapy
KW - Coronary Disease
KW - Fractional Flow Reserve, Myocardial
KW - Humans
KW - Kaplan-Meier Estimate
KW - Myocardial Infarction
KW - Percutaneous Coronary Intervention
KW - Proportional Hazards Models
U2 - 10.1056/NEJMoa1408758
DO - 10.1056/NEJMoa1408758
M3 - Journal article
C2 - 25176289
SN - 0028-4793
VL - 371
SP - 1208
EP - 1217
JO - The New England journal of medicine
JF - The New England journal of medicine
IS - 13
ER -