title: Change in enrollment patterns, patient selection, and clinical outcomes with the availability of drug-eluting stents in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.
abstract: BACKGROUND
  In the BARI 2D trial, patients with type 2 diabetes and stable coronary artery disease were randomized to prompt revascularization versus intensive medical therapy (IMT). This analysis sought to evaluate how the availability of drug-eluting stents (DESs) has changed practice and outcomes.
  
  
  METHODS
  In BARI 2D, 1,605 patients were in the percutaneous coronary intervention (PCI)-intended stratum. As DES became available midway through recruitment, we report clinical outcomes among patients who underwent IMT versus prompt PCI with bare-metal stents (BMSs) or DES up to 4 years.
  
  
  RESULTS
  In North America, after DES became available, selection for the PCI-intended stratum increased from 73% to 79% (P = .003). Fewer BMS than DES patients had total occlusions treated or underwent rotational atherectomy (5.6% vs 9.7%, P = .02, and 1.2% vs 3.7%, P < .01, respectively). Subsequent revascularization (IMT 39%, BMS 29%, DES 21%, P < .01) and target vessel revascularization (BMS 16.1% vs DES 9.6%, P = .03) were lower with DES. Angina at 2 years tended to be less common with DES (IMT 39%, BMS 37%, DES 29%, P = .04, for 3 groups, P = .07 for DES vs BMS). The composite of death, myocardial infarction, or stroke was IMT 16.0%, BMS 20.5%, DES 17.5%; P = .80.
  
  
  CONCLUSIONS
  When DES became available in North America, patients were more likely to be selected into the PCI-intended stratum. Compared with patients receiving BMS, those receiving DES tended to have less target vessel revascularization and angina.
authors.affiliation: New York University School of Medicine, New York, NY.
authors.forename: Binita
authors.initials: B
authors.lastname: Shah
authors.forename: Vankeepuram S
authors.initials: VS
authors.lastname: Srinivas
authors.forename: Jiang
authors.initials: J
authors.lastname: Lu
authors.forename: Maria M
authors.initials: MM
authors.lastname: Brooks
authors.forename: Eric R
authors.initials: ER
authors.lastname: Bates
authors.forename: Zoran S
authors.initials: ZS
authors.lastname: Nedeljkovic
authors.forename: Jorge
authors.initials: J
authors.lastname: Escobedo
authors.forename: Gladwin S
authors.initials: GS
authors.lastname: Das
authors.forename: John J
authors.initials: JJ
authors.lastname: Lopez
authors.forename: Frederick
authors.initials: F
authors.lastname: Feit
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000379:methods*; D003324:Coronary Artery Disease / Q000150:complications / Q000401:mortality / Q000601:surgery*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000401:mortality / Q000601:surgery; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology*; D018579:Patient Selection; D015607:Stents / Q000009:adverse effects*; D020521:Stroke / Q000453:epidemiology / Q000209:etiology*; D015996:Survival Rate; D016896:Treatment Outcome
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