title: Three-year clinical and angiographic follow-up after intracoronary radiation : results of a randomized clinical trial.
abstract: BACKGROUND
  Although several early trials indicate treatment of restenosis with radiation therapy is safe and effective, the long-term impact of this new technology has been questioned. The objective of this report is to document angiographic and clinical outcome 3 years after treatment of restenotic stented coronary arteries with catheter-based (192)Ir.
  
  
  RESULTS
  A double-blind, randomized trial compared (192)Ir with placebo sources in patients with previous restenosis after coronary angioplasty. Over a 9-month period, 55 patients were enrolled; 26 were randomized to (192)Ir and 29 to placebo. At 3-year follow-up, target-lesion revascularization was significantly lower in the (192)Ir group (15. 4% versus 48.3%; P<0.01). The dichotomous restenosis rate at 3-year follow-up was also significantly lower in (192)Ir patients (33% versus 64%; P<0.05). In a subgroup of patients with 3-year angiographic follow-up not subjected to target-lesion revascularization by the 6-month angiogram, the mean minimal luminal diameter between 6 months and 3 years decreased from 2.49+/-0.81 to 2.12+/-0.73 mm in (192)Ir patients but was unchanged in placebo patients.
  
  
  CONCLUSIONS
  The early clinical benefits observed after treatment of coronary restenosis with (192)Ir appear durable at late follow-up. Angiographic restenosis continues to be significantly reduced in (192)Ir-treated patients, but a small amount of late loss was observed between the 6-month and 3-year follow-up time points. No events occurred in the (192)Ir group to suggest major untoward effects of vascular radiotherapy. At 3-year follow-up, vascular radiotherapy continues to be a promising new treatment for restenosis.
authors.affiliation: Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA 92037, USA.
authors.forename: P S
authors.initials: PS
authors.lastname: Teirstein
authors.forename: V
authors.initials: V
authors.lastname: Massullo
authors.forename: S
authors.initials: S
authors.lastname: Jani
authors.forename: J J
authors.initials: JJ
authors.lastname: Popma
authors.forename: R J
authors.initials: RJ
authors.lastname: Russo
authors.forename: R A
authors.initials: RA
authors.lastname: Schatz
authors.forename: E M
authors.initials: EM
authors.lastname: Guarneri
authors.forename: S
authors.initials: S
authors.lastname: Steuterman
authors.forename: K
authors.initials: K
authors.lastname: Sirkin
authors.forename: D A
authors.initials: DA
authors.lastname: Cloutier
authors.forename: M B
authors.initials: MB
authors.lastname: Leon
authors.forename: P
authors.initials: P
authors.lastname: Tripuraneni
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon; D001918:Brachytherapy / Q000401:mortality; D017023:Coronary Angiography; D003327:Coronary Disease / Q000401:mortality / Q000532:radiotherapy* / Q000628:therapy; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular; D006801:Humans; D007496:Iridium Radioisotopes / Q000627:therapeutic use*; D008297:Male; D009203:Myocardial Infarction / Q000601:surgery / Q000628:therapy; D010919:Placebos; D012008:Recurrence; D015607:Stents; D016019:Survival Analysis
chemical_list: D007496:Iridium Radioisotopes; D010919:Placebos