title: Quantitative angiographic methods for appropriate end-point analysis, edge-effect evaluation, and prediction of recurrent restenosis after coronary brachytherapy with gamma irradiation.
abstract: OBJECTIVE
  The study was done to investigate the relationship between clinical restenosis and the relative angiographic location of the recurrent restenotic lesion, after treatment of in-stent restenosis with vascular brachytherapy in the Washington Radiation for In-Stent Restenosis Trial (WRIST).
  
  
  BACKGROUND
  Intracoronary radiation therapy reduces recurrence of in-stent restenosis. We investigated the above objective in patients enrolled in WRIST.
  
  
  METHODS
  The WRIST study randomized 130 patients to double-blinded therapy with gamma irradiation (iridium-192 [(192)Ir]) versus placebo after interventional treatment of diffuse in-stent restenosis. After the intervention and at follow-up, three vessel segments were individually analyzed with quantitative coronary angiography: 1) the "stent," 2) the "radiation ribbon," and 3) the "ribbon+margin" segment (including 5 mm on either end of the injured or radiation-ribbon segment). Receiver operator curves (ROC) were used to assess the value of the follow-up percent diameter stenosis (DS) for each of the three analyzed segments in predicting target vessel revascularization (TVR).
  
  
  RESULTS
  (192)Ir reduced recurrent restenosis (23.7% vs. 60.7%, p < 0.001) and the length of recurrent restenosis (8.99 +/- 4.34 mm vs. 17.54 +/- 10.48 mm, p < 0.001) at follow-up compared to placebo. Isolated stent edge (3.4%) and ribbon edge (1.7%) restenoses were infrequent in both groups. The best angiographic surrogate of TVR was the 50% follow-up DS obtained from the ribbon+margin analysis (ROC area 0.806).
  
  
  CONCLUSIONS
  In WRIST, not only was (192)Ir therapy effective in reducing restenosis, but it also reduced the lesion length of treatment failures by 50%, and it was not associated with edge proliferation. The restenosis rate obtained from the vessel segment inclusive of the dose fall-off zones was the best correlate of TVR and should become a standard analysis site in all vascular brachytherapy trials.
authors.affiliation: Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, New York 10022, USA. alansky@crf.org
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: George
authors.initials: G
authors.lastname: Dangas
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Kartik J
authors.initials: KJ
authors.lastname: Desai
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.forename: Hongsheng
authors.initials: H
authors.lastname: Wu
authors.forename: Martin
authors.initials: M
authors.lastname: Fahy
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D001918:Brachytherapy; D017023:Coronary Angiography / Q000379:methods*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging*; D006801:Humans; D007496:Iridium Radioisotopes / Q000627:therapeutic use*; D016015:Logistic Models; D012372:ROC Curve; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012680:Sensitivity and Specificity
chemical_list: D007496:Iridium Radioisotopes