title: A European multi-center trial investigating the anti-restenotic effect of intravascular sonotherapy after stenting of de novo lesions (EUROSPAH: EUROpean Sonotherapy Prevention of Arterial Hyperplasia).
abstract: BACKGROUND
  Intravascular sonotherapy (IST) reduces neointimal hyperplasia post-stenting in animal studies. Euro-SPAH is a multi-center, double blind, randomized trial investigating the efficacy of IST to reduce in-stent late loss.
  
  
  METHODS
  Patients with angina or silent ischaemia with stented de novo lesions were randomised to sham or IST. The sample size had a 90% power to detect a late loss difference of 0.21 mm at 6 months. The secondary endpoints were MACE at 1, 6, 12 months and neo-intimal hyperplasia on IVUS at 6 months.
  
  
  RESULTS
  At 23 sites in Europe, 403 patients were randomized, with successful treatment with sham or IST in 95.6%. There were no significant differences between the groups in terms of baseline demographics or lesion characteristics. Angiographic follow-up was obtained in 89%. In-stent late loss was not significantly different. The restenosis rate at 6 months was 23% in the IST group versus 25% in the sham group. The IVUS measurements confirm the absence of effect of IST on neointimal hyperplasia. At one year, the event-free survival did not significantly differ between the two groups.
  
  
  CONCLUSIONS
  The use of sonotherapy following stent implantation in de novo lesions does not reduce intra-stent neointimal hyperplasia, or effect the angiographic restenosis rate compared to sham treatment.
authors.affiliation: Thoraxcentre, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl
authors.forename: P W
authors.initials: PW
authors.lastname: Serruys
authors.forename: A
authors.initials: A
authors.lastname: Hoye
authors.forename: G
authors.initials: G
authors.lastname: Grollier
authors.forename: A
authors.initials: A
authors.lastname: Colombo
authors.forename: J
authors.initials: J
authors.lastname: Symons
authors.forename: H
authors.initials: H
authors.lastname: Mudra
mesh_terms: D000368:Aged; D019917:Blood Vessel Prosthesis Implantation; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012086:Reoperation; D015607:Stents; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional