title: Long-term outcome of PCI versus CABG in insulin and non-insulin-treated diabetic patients: results from the FREEDOM trial.
abstract: BACKGROUND
  The prospective, randomized FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial found coronary artery bypass graft surgery (CABG) was associated with better clinical outcomes than percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease, managed with or without insulin.
  
  
  OBJECTIVE
  In this subgroup analysis of the FREEDOM trial, we examined the association of long-term clinical outcomes after revascularization in patients with insulin-treated diabetes mellitus (ITDM) compared with patients not treated with insulin.
  
  
  METHODS
  A total of 1,850 FREEDOM subjects had an index revascularization procedure performed: 956 underwent PCI with drug-eluting stents (DES), and 894 underwent CABG. A total of 602 patients (32.5%) had ITDM (PCI/DES n = 325, 34%; CABG n = 277, 31%). Subjects were classified according to ITDM versus non-ITDM, with comparison of PCI/DES versus CABG for each group. Interaction analyses were performed for treatment by diabetes mellitus (DM) status alone and for treatment by DM status by coronary lesion complexity. Analyses were performed for the primary outcome composite of death/stroke/myocardial infarction (MI) using all available follow-up data.
  
  
  RESULTS
  The overall 5-year event rate of death/stroke/MI was significantly higher in ITDM versus non-ITDM patients (28.7% vs. 19.5%, p < 0.001), which persisted even after adjustment for multiple baseline factors, angiographic complexity, and revascularization treatment group (death/stroke/MI hazard ratio [HR]: 1.35, 95% confidence interval [CI]: 1.06 to 1.73, p = 0.014). With respect to the primary composite endpoint, CABG was superior to PCI/DES in both DM types and the magnitude of treatment effect was similar (interaction p = 0.40) for ITDM (PCI vs.
  1.21; 95% CI: 0.87 to 1.69) and non-ITDM patients (PCI vs.
  1.46; 95% CI 1.10 to 1.94), even after adjusting for the angiographic SYNTAX score level. Based on 5-year event rates, the number needed to treat with CABG versus PCI to prevent 1 event is 12.7 in ITDM and 13.2 in non-ITDM.
  
  
  CONCLUSIONS
  In patients with diabetes and multivessel coronary artery disease, the rate of major adverse cardiovascular events (death, MI, or stroke) is higher in patients treated with insulin than in those not treated with insulin. Furthermore, we did not detect a significant difference in the magnitude of PCI versus CABG treatment effect for patients treated with insulin and those not treated with insulin. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: george.dangas@mountsinai.org.
authors.forename: George D
authors.initials: GD
authors.lastname: Dangas
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Farkouh
authors.affiliation: New England Research Institutes, Inc., Watertown, Massachusetts.
authors.forename: Lynn A
authors.initials: LA
authors.lastname: Sleeper
authors.affiliation: New England Research Institutes, Inc., Watertown, Massachusetts.
authors.forename: May
authors.initials: M
authors.lastname: Yang
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Mikkel M
authors.initials: MM
authors.lastname: Schoos
authors.affiliation: Clínico San Carlos University Hospital, Madrid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
authors.affiliation: Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Vancouver Hospital & Health Science Centre, Vancouver, British Columbia, Canada.
authors.forename: Christopher E
authors.initials: CE
authors.lastname: Buller
authors.affiliation: Department of Cardiology, Waikato Hospital, Hamilton, New Zealand.
authors.forename: Gerard
authors.initials: G
authors.lastname: Devlin
authors.affiliation: Cardiac Unit, Otamendi Hospital, Buenos Aires School of Medicine, Buenos Aires, Argentina.
authors.forename: Alfredo E
authors.initials: AE
authors.lastname: Rodriguez
authors.affiliation: Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.affiliation: New England Research Institutes, Inc., Watertown, Massachusetts.
authors.forename: F Sandra
authors.initials: FS
authors.lastname: Siami
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Michael
authors.initials: M
authors.lastname: Domanski
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Valentin
authors.initials: V
authors.lastname: Fuster
mesh_terms: D000368:Aged; D001026:Coronary Artery Bypass / Q000401:mortality / Q000639:trends*; D003920:Diabetes Mellitus / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007328:Insulin / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000401:mortality / Q000639:trends*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007328:Insulin
keywords: angioplasty; coronary bypass surgery; diabetes; revascularization