title: Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease.
abstract: BACKGROUND
  The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone.
  
  
  METHODS
  In patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.
  
  
  RESULTS
  Recruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event.
  
  
  CONCLUSIONS
  In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.).
authors.affiliation: Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium. bernard.de.bruyne@olvz-aalst.be
authors.forename: Bernard
authors.initials: B
authors.lastname: De Bruyne
authors.forename: Nico H J
authors.initials: NH
authors.lastname: Pijls
authors.forename: Bindu
authors.initials: B
authors.lastname: Kalesan
authors.forename: Emanuele
authors.initials: E
authors.lastname: Barbato
authors.forename: Pim A L
authors.initials: PA
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: Möbius-Winkler
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 G
authors.initials: KG
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: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: William F
authors.initials: WF
authors.lastname: Fearon
mesh_terms: D058671:Adrenergic beta-1 Receptor Antagonists; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003327:Coronary Disease / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy*; D023921:Coronary Stenosis / Q000628:therapy; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D053805:Fractional Flow Reserve, Myocardial; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D019233:Retreatment
chemical_list: D058671:Adrenergic beta-1 Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D010975:Platelet Aggregation Inhibitors; D001241:Aspirin