title: Intracoronary brachytherapy after stenting de novo lesions in diabetic patients: results of a randomized intravascular ultrasound study.
abstract: OBJECTIVE
  We studied the efficacy of intracoronary brachytherapy (ICB) after successful coronary stenting in diabetic patients with de novo lesions.
  
  
  BACKGROUND
  Intracoronary brachytherapy has proven effective in preventing recurrences in patients with in-stent restenosis. However, the role of ICB for the treatment of de novo coronary stenoses remains controversial.
  
  
  METHODS
  Ninety-two patients were randomized to either ICB or no radiation after stenting. Primary end points were in-stent mean neointimal area (primary end point of efficacy) and minimal luminal area of the entire vessel segment (primary end point of effectiveness), as assessed by intravascular ultrasound at six-month follow-up. Quantitative coronary angiography analysis was performed at the target, injured, irradiated, and entire vessel segments.
  
  
  RESULTS
  At follow-up, the in-stent mean neointimal area was 52% smaller in the ICB group (p < 0.0001). However, there was no difference in the minimal luminal area of the vessel segment (4.5 +/- 2.4 mm2 vs. 4.4 +/- 2.1 mm2). Restenosis rates increased progressively by the analyzed segment in the ICB group: target (7.1% vs. 20.9%, p = 0.07), injured (9.5% vs. 20.9%, p = NS), irradiated (14.3% vs. 20.9%, p = NS), and vessel segment (23.8% vs. 25.6%, p = NS). At one year, 1 cardiac death, 6 myocardial infarctions (MIs) (3 due to late stent thrombosis), and 10 target vessel revascularizations (TVRs) (6 due to the edge effect) occurred in the ICB group, whereas in the nonradiation group, there were 11 TVRs and no deaths or MIs.
  
  
  CONCLUSIONS
  Intracoronary brachytherapy significantly inhibited in-stent neointimal hyperplasia after stenting in diabetic patients. However, clinically this was counteracted by the occurrence of the edge effect and late stent thrombosis.
authors.affiliation: San Carlos University Hospital, Madrid, Spain. msabate.hcsc@salud.madrid.org
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
authors.forename: Gela
authors.initials: G
authors.lastname: Pimentel
authors.forename: Carlos
authors.initials: C
authors.lastname: Prieto
authors.forename: José María
authors.initials: JM
authors.lastname: Corral
authors.forename: Camino
authors.initials: C
authors.lastname: Bañuelos
authors.forename: Dominick J
authors.initials: DJ
authors.lastname: Angiolillo
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfonso
authors.forename: Rosana
authors.initials: R
authors.lastname: Hernández-Antolín
authors.forename: Javier
authors.initials: J
authors.lastname: Escaned
authors.forename: Panayotis
authors.initials: P
authors.lastname: Fantidis
authors.forename: Cristina
authors.initials: C
authors.lastname: Fernández
authors.forename: Antonio
authors.initials: A
authors.lastname: Fernández-Ortiz
authors.forename: Raúl
authors.initials: R
authors.lastname: Moreno
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
mesh_terms: D000368:Aged; D001918:Brachytherapy; D023903:Coronary Restenosis / Q000453:epidemiology; D023921:Coronary Stenosis / Q000150:complications / Q000000981:diagnostic imaging* / Q000532:radiotherapy*; D003328:Coronary Thrombosis / Q000209:etiology; D016757:Death, Sudden, Cardiac / Q000453:epidemiology; D048909:Diabetes Complications; D005260:Female; D006801:Humans; D006965:Hyperplasia / Q000517:prevention & control; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D012086:Reoperation; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome; D017539:Tunica Intima / Q000473:pathology; D018084:Ultrasonography, Interventional