A European multi-center trial investigating the anti-restenotic effect of intravascular sonotherapy after stenting de novo lesions (EUROSPAH: EUROpean Sonotherapy Prevention of Arterial Hyperplasia)

P. W. Serruys, A. Hoye, G. Grollier, A. Colombo, J. Symons, H. Mudra

Research output: Contribution to journalArticlepeer-review

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. CONCLUSION: 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.

Original languageEnglish
Pages (from-to)53-60
Number of pages8
JournalInternational Journal of Cardiovascular Interventions
Volume6
Issue number2
DOIs
Publication statusPublished - 2004

Keywords

  • Angioplasty
  • Restenosis
  • Sonotherapy
  • Stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

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