title: Sirolimus-eluting stent implantation versus beta-irradiation for the treatment of in-stent restenotic lesions: clinical and ultrasound results from a randomised trial.
abstract: OBJECTIVE
  Recent trials with different designs indicated that drug-eluting stents may be superior to vascular brachytherapy (VBT) for the treatment of in-stent restenosis (ISR). We performed a randomised, double-centre, clinical, quantitative coronary angiographic (QCA) and intravascular ultrasound (IVUS) acute and 3-years comparison of 90Sr/90Y-VBT and sirolimus-eluting stent implantation (SES) for ISR.
  
  
  RESULTS
  Ninety-one (91) consecutive patients were included. By QCA, SES led to a higher acute gain (2.08 ± 0.41 mm vs. 1.54 ± 0.70 mm, p < 0.0001), higher postprocedural minimum lumen diameter (2.76 ± 0.39 mm vs. 2.39 ± 0.52 mm; p < 0.0001), lower late lumen loss at follow-up (0.09 ± 0.29 vs. 0.39 ± 0.79 mm, p = 0.042), and a higher net lumen gain of the target lesion (2.05 ± 0.51 vs 1.18 ± 1.08 mm, p < 0.0001). By IVUS, the smaller acute gain following VBT was the result of residual intima hyperplasia, the intima hyperplasia formation following SES was extremely low, and the edge-effect was virtually absent after SES, respectively. At 6-month follow-up, both the angiographic restenosis rate (4.7 vs. 22.7%; p < 0.0001) and target lesion revascularisation rate (2.3 vs. 10.4%; p = 0.025) were lower in SES. Importantly, SES showed a stable clinical course at 3-year follow-up while VBT was associated with a sustained incidence of target vessel failure (11.6 vs. 46.7%; p < 0.0001).
  
  
  CONCLUSIONS
  SES for ISR is associated with superior QCA, IVUS and clinical results at 6-month and 3-year of follow-up when compared with VBT.
authors.affiliation: Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany. mwiemer@hdz-nrw.de
authors.forename: Marcus
authors.initials: M
authors.lastname: Wiemer
authors.forename: Andreas
authors.initials: A
authors.lastname: König
authors.forename: Johannes
authors.initials: J
authors.lastname: Rieber
authors.forename: Hae-Young
authors.initials: HY
authors.lastname: Sohn
authors.forename: Marcus
authors.initials: M
authors.lastname: Leibig
authors.forename: Karl
authors.initials: K
authors.lastname: Theisen
authors.forename: Volker
authors.initials: V
authors.lastname: Klauss
authors.forename: Christoph
authors.initials: C
authors.lastname: Langer
authors.forename: Oliver
authors.initials: O
authors.lastname: Lindner
authors.forename: Dieter
authors.initials: D
authors.lastname: Horstkotte
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Schiele
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001918:Brachytherapy / Q000009:adverse effects / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000532:radiotherapy / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013326:Strontium Radioisotopes / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D015021:Yttrium Radioisotopes / Q000627:therapeutic use
chemical_list: D002317:Cardiovascular Agents; D013326:Strontium Radioisotopes; D015021:Yttrium Radioisotopes; D020123:Sirolimus