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

A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study

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

Received August 28, 2002;

revision received October 28, 2002; accepted October 30, 2002.

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 [email protected]

Circulation 107(1):p 24-27, January 7/14, 2003.

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.