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J Am Coll Cardiol, 2003; 41:184-189
© 2003 by the American College of Cardiology Foundation
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CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY

Sirolimus-eluting stent for treatment of complex in-stent restenosis

The first clinical experience

Muzaffer Degertekin, MD*, Evelyn Regar, MD*, Kengo Tanabe, MD*, Pieter C. Smits, MD, PhD*, Willem J. van der Giessen, MD, PhD, FACC*, Stephan G. Carlier, MD, PhD*, Pim de Feyter, MD, PhD, FACC*, Jeroen Vos, MD, PhD*, David P. Foley, MD, PhD, FACC*, Jurgen M. R. Ligthart, MSc*, Jeffrey J. Popma, MD, FACC{dagger} and Patrick W. Serruys, MD, PhD, FACC*,*

* Thoraxcenter, University Hospital Rotterdam, Rotterdam, The Netherlands
{dagger} Brigham and Women’s Hospital, Boston, Massachusetts, USA

Manuscript received May 29, 2002; revised manuscript received July 30, 2002, accepted August 19, 2002.

* Reprint requests and correspondence: Prof. Patrick W. Serruys, Head of Interventional Department, Thoraxcentre, Bd. 408, University Hospital Dijkzigt, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.
Serruys{at}card.azr.nl

OBJECTIVES: In this study, we assess the value of sirolimus eluting stent (SES) implantation in patients with complex in-stent restenosis (ISR).

BACKGROUND: The treatment of ISR remains a therapeutic challenge, since many pharmacological and mechanical approaches have shown disappointing results. The SESs have been reported to be effective in de-novo coronary lesions.

METHODS: Sixteen patients with severe, recurrent ISR in a native coronary artery (average lesion length 18.4 mm) and objective evidence of ischemia were included. They received one or more 18 mm Bx VELOCITY SESs (Cordis Waterloo, Belgium). Quantitative angiographic and three-dimensional intravascular ultrasound (IVUS) follow-up was performed at four months, and clinical follow-up at nine months.

RESULTS: The SES implantation (n = 26) was successful in all 16 patients. Four patients had recurrent restenosis following brachytherapy, and three patients had totally occluded vessels preprocedure. At four months follow-up, one patient had died and three patients had angiographic evidence of restenosis (one in-stent and two in-lesion). In-stent late lumen loss averaged 0.21 mm and the volume obstruction of the stent by IVUS was 1.1%. At nine months clinical follow-up, three patients had experienced four major adverse cardiac events (two deaths and one acute myocardial infarction necessitating repeat target vessel angioplasty).

CONCLUSIONS: The SES implantation in patients with severe ISR lesions effectively prevents neointima formation and recurrent restenosis at four months angiographic follow-up.

Abbreviations and Acronyms
  DS
  diameter stenosis
  ISR
  in-stent restenosis
  IVUS
  intravascular ultrasound
  NIH
  neointimal hyperplasia
  QCA
  quantitative coronary angiography
  SES
  sirolimus eluting stent
  TIMI
  Thrombolysis In Myocardial Infarction




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