title: The effect of intracoronary radiation for the treatment of recurrent in-stent restenosis in patients with diabetes mellitus.
abstract: OBJECTIVE
  The purpose of this study was to examine the effect of intracoronary radiation therapy (IRT) in diabetic patients with in-stent restenosis (ISR).
  
  
  BACKGROUND
  Diabetic patients are at an increased risk for restenosis, repeat revascularization procedures and late mortality after percutaneous coronary interventions and stenting. Intracoronary radiation therapy, utilizing both gamma and beta-emitters, has been shown to reduce the rate of ISR.
  
  
  METHODS
  The study group consisted of 749 consecutive patients with ISR who were treated with either IRT or placebo in randomized trials and registries at our center. Diabetic patients (252 radiation and 51 placebo) were compared with nondiabetic patients (371 radiation and 75 placebo).
  
  
  RESULTS
  In-hospital outcomes were similar between diabetic and nondiabetic patients treated with and without radiation. At six-month clinical and angiographic follow-up, there was a significant reduction in the binary restenosis (63.8% vs. 15.7%, p < 0.0001), target lesion revascularization (66.7% vs. 17.6%, p < 0.0001) and target vessel revascularization (TVR) (70.6% vs. 22.9%, p < 0.0001) rates in diabetic patients treated with radiation compared to placebo. Comparisons between the placebo arms detected a trend towards higher restenosis (63.8% vs. 48.4% p = 0.13) and TVR (70.6% vs. 56.0%, p = 0.14) in diabetic versus nondiabetic patients. In contrast, diabetic and nondiabetic patients treated with IRT experienced similar restenosis (15.6% vs. 10.7% p = 0.33) and TVR (22.9% vs. 28.2% p = 0.41) rates.
  
  
  CONCLUSIONS
  In diabetic patients with ISR, intracoronary radiation significantly reduced the recurrence of ISR compared to placebo. Additionally, similar rates of restenosis and revascularization procedures were achieved in irradiated diabetic and nondiabetic patients. In view of these results, IRT should be considered as a valuable therapeutic alternative in all diabetic patients with ISR.
authors.affiliation: Cardiovascular Research Institute, Washington Hospital Center, Washington, DC 20010, USA.
authors.forename: Luis
authors.initials: L
authors.lastname: Gruberg
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Ajani
authors.forename: Han-Soo
authors.initials: HS
authors.lastname: Kim
authors.forename: R Lawrence
authors.initials: RL
authors.lastname: White
authors.forename: Ellen E
authors.initials: EE
authors.lastname: Pinnow
authors.forename: Lowell F
authors.initials: LF
authors.lastname: Satler
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Kent
authors.forename: Joseph
authors.initials: J
authors.lastname: Lindsay
mesh_terms: D000368:Aged; D001918:Brachytherapy; D023903:Coronary Restenosis / Q000517:prevention & control / Q000532:radiotherapy*; D003331:Coronary Vessels / Q000528:radiation effects*; D003925:Diabetic Angiopathies / Q000532:radiotherapy* / Q000628:therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012189:Retrospective Studies; D015607:Stents; D016896:Treatment Outcome