title: Intracoronary beta-irradiation with a rhenium-188-filled balloon catheter: a randomized trial in patients with de novo and restenotic lesions.
abstract: BACKGROUND
  Restenosis requiring reintervention is the main limitation of coronary angioplasty. Intracoronary irradiation reduces neointimal proliferation. We studied the efficacy of a self-centering liquid rhenium-188-filled balloon catheter for coronary beta-brachytherapy.
  
  
  RESULTS
  After successful coronary angioplasty with or without stenting, 225 patients (71% de novo lesions) were randomly assigned to receive 22.5 Gy intravascular beta-irradiation in 0.5-mm tissue depth (n=113) or to receive no additional intervention (n=112). Clinical and procedural data did not differ between the groups except a higher rate of stenting in the control group (63%) compared with the rhenium-188 group (45%, P<0.02). After 6 months of follow-up, late loss was significantly lower in the irradiated group compared with the control group, both of the target lesion (0.11+/-0.54 versus 0.69+/-0.81 mm, P<0.0001) and of the total segment (0.22+/-0.67 versus 0.70+/-0.82 mm, P<0.0001). This was also evident in the subgroup of patients with de novo lesions and independent from stenting. Binary restenosis rates were significantly lower at the target lesion (6.3% versus 27.5%, P<0.0001) and of the total segment (12.6% versus 28.6%, P<0.007) after rhenium-188 brachytherapy compared with the control group. Target vessel revascularization rate was significantly lower in the rhenium-188 (6.3%) compared with the control group (19.8%, P=0.006).
  
  
  CONCLUSIONS
  Intracoronary beta-brachytherapy with a rhenium-188 liquid-filled balloon is safe and efficiently reduces restenosis and revascularization rates after coronary angioplasty.
authors.affiliation: Department of Internal Medicine II, University of Ulm, Robert-Koch-Strasse-8, 89081 Ulm, Germany. martin.hoeher@medizin.uni-ulm.de
authors.forename: Martin
authors.initials: M
authors.lastname: Höher
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.forename: Markus
authors.initials: M
authors.lastname: Wohlfrom
authors.forename: Joachim
authors.initials: J
authors.lastname: Kamenz
authors.forename: Thorsten
authors.initials: T
authors.lastname: Nusser
authors.forename: Olaf C
authors.initials: OC
authors.lastname: Grebe
authors.forename: Hartmut
authors.initials: H
authors.lastname: Hanke
authors.forename: Matthias
authors.initials: M
authors.lastname: Kochs
authors.forename: Sven N
authors.initials: SN
authors.lastname: Reske
authors.forename: Vinzenz
authors.initials: V
authors.lastname: Hombach
authors.forename: Jörg
authors.initials: J
authors.lastname: Kotzerke
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation; D001610:Beta Particles / Q000627:therapeutic use*; D001918:Brachytherapy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D002404:Catheterization / Q000295:instrumentation; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000532:radiotherapy* / Q000628:therapy; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control / Q000532:radiotherapy; D004307:Dose-Response Relationship, Radiation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011868:Radioisotopes; D012211:Rhenium; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D011868:Radioisotopes; D012211:Rhenium