title: Fractional flow reserve-guided PCI for stable coronary artery disease.
abstract: 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.).
authors.affiliation: The authors' affiliations are listed in the Appendix.
authors.forename: Bernard
authors.initials: B
authors.lastname: De Bruyne
authors.forename: William F
authors.initials: WF
authors.lastname: Fearon
authors.forename: Nico H J
authors.initials: NH
authors.lastname: Pijls
authors.forename: Emanuele
authors.initials: E
authors.lastname: Barbato
authors.forename: Pim
authors.initials: P
authors.lastname: Tonino
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Piroth
authors.forename: Nikola
authors.initials: N
authors.lastname: Jagic
authors.forename: Sven
authors.initials: S
authors.lastname: Mobius-Winckler
authors.forename: Gilles
authors.initials: G
authors.lastname: Rioufol
authors.forename: Nils
authors.initials: N
authors.lastname: Witt
authors.forename: Petr
authors.initials: P
authors.lastname: Kala
authors.forename: Philip
authors.initials: P
authors.lastname: MacCarthy
authors.forename: Thomas
authors.initials: T
authors.lastname: Engström
authors.forename: Keith
authors.initials: K
authors.lastname: Oldroyd
authors.forename: Kreton
authors.initials: K
authors.lastname: Mavromatis
authors.forename: Ganesh
authors.initials: G
authors.lastname: Manoharan
authors.forename: Peter
authors.initials: P
authors.lastname: Verlee
authors.forename: Ole
authors.initials: O
authors.lastname: Frobert
authors.forename: Nick
authors.initials: N
authors.lastname: Curzen
authors.forename: Jane B
authors.initials: JB
authors.lastname: Johnson
authors.forename: Andreas
authors.initials: A
authors.lastname: Limacher
authors.forename: Eveline
authors.initials: E
authors.lastname: Nüesch
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D057911:Angiotensin Receptor Antagonists / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003327:Coronary Disease / Q000188:drug therapy / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053805:Fractional Flow Reserve, Myocardial; D006801:Humans; D053208:Kaplan-Meier Estimate; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods*; D016016:Proportional Hazards Models
chemical_list: D000319:Adrenergic beta-Antagonists; D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors