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(Circulation. 2003;107:24.)
© 2003 American Heart Association, Inc.

Brief Rapid Communications

Sirolimus-Eluting Stent for the Treatment of In-Stent Restenosis

A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study

J. Eduardo Sousa, MD, PhD; Marco A. Costa, MD, PhD; Alexandre Abizaid, MD, PhD; Amanda G.M.R. Sousa, MD, PhD; Fausto Feres, MD, PhD; Luiz A. Mattos, MD, PhD; Marinella Centemero, MD; Galo Maldonado, MD; Andrea S. Abizaid, MD; Ibraim Pinto, MD; Robert Falotico, PhD; Judith Jaeger, BA; Jeffrey J. Popma, MD; Patrick W. Serruys, MD, PhD

From the Institute Dante Pazzanese of Cardiology, São Paulo, Brazil (J.E.S., A.A., A.G.M.R.S., F.F., L.A.M., M.C., G.M., A.S.A., I.P.); University of Florida-Shands, Jacksonville (M.A.C.); Cordis, a Johnson & Johnson Company, Warren, NJ (R.F., J.J.); Brigham and Women’s Hospital, Boston, Mass (J.J.P.); and Thoraxcenter, Dijkzigt University Hospital, Rotterdam, The Netherlands (P.W.S.).

Correspondence to Prof J. Eduardo Sousa, MD, PhD, Director of the Institute Dante Pazzanese of Cardiology, Av. Dr Dante Pazzanese, 500 - Ibirapuera, 04012180, São Paulo, Brazil. E-mail jesousa{at}uol.com.br

Background— We have previously reported the safety and effectiveness of sirolimus-eluting stents for the treatment of de novo coronary lesions. The present investigation explored the potential of this technology to treat in-stent restenosis.

Methods and Results— Twenty-five patients with in-stent restenosis were successfully treated with the implantation of 1 or 2 sirolimus-eluting Bx VELOCITY stents in São Paulo, Brazil. Nine patients received 2 stents (1.4 stents per lesion). Angiographic and volumetric intravascular ultrasound (IVUS) images were obtained after the procedure and at 4 and 12 months. All vessels were patent at the time of 12-month angiography. Angiographic late loss averaged 0.07±0.2 mm in-stent and -0.05±0.3 mm in-lesion at 4 months, and 0.36±0.46 mm in-stent and 0.16±0.42 mm in-lesion after 12 months. No patient had in-stent or stent margin restenosis at 4 months, and only one patient developed in-stent restenosis at 1-year follow-up. Intimal hyperplasia by 3-dimensional IVUS was 0.92±1.9 mm³ at 4 months and 2.55±4.9 mm³ after 1 year. Percent volume obstruction was 0.81±1.7% and 1.76±3.4% at the 4- and 12-month follow-up, respectively. There was no evidence of stent malapposition either acutely or in the follow-up IVUS images, and there were no deaths, stent thromboses, or repeat revascularizations.

Conclusion— This study demonstrates the safety and the potential utility of sirolimus-eluting Bx VELOCITY stents for the treatment of in-stent restenosis.

Key Words: stents • restenosis • drugs • angiography • ultrasonics