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(Circulation. 2005;111:2107-2111.)
© 2005 American Heart Association, Inc.

Interventional Cardiology

Effectiveness and Safety of Sirolimus-Eluting Stents in the Treatment of Restenosis After Coronary Stent Placement

Franz-Josef Neumann, MD; Walter Desmet, MD; Eberhard Grube, MD; Johannes Brachmann, MD; Patrizia Presbitero, MD; Paolo Rubartelli, MD; Andreas Mügge, MD; Francesco Di Pede, MD; Diana Füllgraf, MD; Wim Aengevaeren, MD; Leonardo Spedicato, MD; Jeffrey J. Popma, MD

From the Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany (F.-J.N.); Department of Cardiology, University Hospitals Leuven, Leuven, Belgium (W.D.); Krankenhaus Siegburg GmbH, Herzzentrum, Siegburg, Germany (E.G.); Klinikum Coburg, Coburg, Germany (J.B.); Istituto Clinico Humanitas, Rozzano, Italy (P.P.); Ospedale S. Martino, Genova, Italy (P.R.); St Josef Hospital/Ruhr-Universität Bochum, Bochum, Germany (A.M.); Ospedale Civile Di Mestre, Mestre, Italy (F.D.P.); Klinikum Lüdenscheid, Lüdenscheid, Germany (D.F.); University Medical Center St Radboud, Nijmegen, the Netherlands (W.A.); Ospedale S Maria Della Misericordia, Udine, Italy (L.S.); and Brigham and Women’s Hospital, Boston, Mass (J.J.P.).

Correspondence to Franz-Josef Neumann, MD, Herz-Zentrum Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany. E-mail franz-josef.neumann{at}herzzentrum.de

Received September 25, 2004; revision received January 1, 2005; accepted January 11, 2005.

Background— In-stent restenosis is notoriously difficult to treat by repeat catheter intervention because of its propensity for aggressive recurrent neointimal formation. This study sought to assess the effectiveness and safety of the sirolimus-eluting stent in the treatment of in-stent restenosis.

Methods and Results— The study was designed as a prospective multicenter registry. We included 162 patients with in-stent restenosis of a native coronary artery who had a clinical indication for repeat intervention. Patients were scheduled for follow-up angiography at 6 months. The primary end point was in-lesion late loss. Follow-up angiography was performed in 155 patients. We obtained an in-lesion late loss of 0.08±0.49 mm and a binary restenosis rate of 9.7% (15/155), which prompted reintervention in 7.4% (12/162) at 9 months. The 9-month rate of death was 1.2% (2/162) and that of nonfatal myocardial infarction was 1.2% (2/162).

Conclusions— Sirolimus-eluting stents were highly efficacious and safe in the treatment of in-stent restenosis. Our study provides rationale for the use of sirolimus-eluting stents in the treatment of in-stent restenosis.

Key Words: restenosis • sirolimus • stents

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