title: Five-year clinical follow-up after intracoronary radiation: results of a randomized clinical trial.
abstract: BACKGROUND
  Several clinical trials indicate that intracoronary radiation is safe and effective for treatment of restenotic coronary arteries. We previously reported 6-month and 3-year clinical and angiographic follow-up demonstrating significant decreases in target lesion revascularization (TLR) and angiographic restenosis after gamma radiation of restenotic lesions. The objective of this study was to document the clinical outcome 5 years after treatment of restenotic coronary arteries with catheter-based iridium-192 (192Ir).
  
  
  RESULTS
  A double-blind, randomized trail compared 192Ir to placebo sources in patients with restenosis after coronary angioplasty. Over a 9-month period, 55 patients were enrolled; 26 were randomized to 192Ir and 29 to placebo. At 5-year follow-up, TLR was significantly lower in the 192Ir group (23.1% versus 48.3%; P=0.05). There were 2 TLRs between years 3 and 5 in patients in the 192Ir group and none in patients in the placebo group. The 5-year event-free survival rate (freedom from death, myocardial infarction, or TLR) was greater in 192Ir-treated patients (61.5% versus 34.5%; P=0.02).
  
  
  CONCLUSIONS
  Despite apparent mitigation of efficacy over time, there remains a significant reduction in TLR at 5 years and an improvement in event-free survival in patients treated with intracoronary 192Ir. The early clinical benefits after intracoronary gamma radiation with 192Ir seem durable at 5-year clinical follow-up.
authors.affiliation: Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, Calif 92037, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Grise
authors.forename: Vincent
authors.initials: V
authors.lastname: Massullo
authors.forename: Shirish
authors.initials: S
authors.lastname: Jani
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Russo
authors.forename: Richard A
authors.initials: RA
authors.lastname: Schatz
authors.forename: Erminia M
authors.initials: EM
authors.lastname: Guarneri
authors.forename: Stephen
authors.initials: S
authors.lastname: Steuterman
authors.forename: David A
authors.initials: DA
authors.lastname: Cloutier
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Prabhakar
authors.initials: P
authors.lastname: Tripuraneni
authors.forename: Paul S
authors.initials: PS
authors.lastname: Teirstein
mesh_terms: D000368:Aged; D001918:Brachytherapy; D006328:Cardiac Catheterization; D017023:Coronary Angiography; D003326:Coronary Circulation; D023903:Coronary Restenosis / Q000097:blood / Q000175:diagnosis / Q000532:radiotherapy*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005720:Gamma Rays; D006801:Humans; D007496:Iridium Radioisotopes / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D009389:Neovascularization, Pathologic; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D007496:Iridium Radioisotopes