(Circulation. 2001;104:2007-2011.)
© 2001 American Heart Association, Inc.
Clinical Investigation and Reports |
From the Institute Dante Pazzanese of Cardiology (J.E.S., M.A.C., A.C.A., A.S.A., L.F.T., A.G.M.R.S.), São Paulo, Brazil; Thoraxcenter, Dijkzigt University Hospital (B.J.R., K.K., G.V.L. P.W.S.), Rotterdam, The Netherlands; Cordis, a Johnson and Johnson Company (R.F., J.J.), Warren, NJ; and Brigham and Womens Hospital (J.J.P.), Boston, Mass.
Correspondence to Professor 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 a virtual absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting stents. The aim of the present investigation was to determine whether these results are sustained over a period of 1 year.
Methods and Results Forty-five patients with de novo coronary disease were successfully treated with the implantation of a single sirolimus-eluting Bx VELOCITY stent in São Paulo, Brazil (n=30, 15 fast release [group I, GI] and 15 slow release [GII]) and Rotterdam, The Netherlands (15 slow release, GIII). Angiographic and volumetric intravascular ultrasound (IVUS) follow-up was obtained at 4 and 12 months (GI and GII) and 6 months (GIII). In-stent minimal lumen diameter and percent diameter stenosis remained essentially unchanged in all groups (at 12 months, GI and GII; at 6 months, GIII). Follow-up in-lesion minimal lumen diameter was 2.28 mm (GIII), 2.32 mm (GI), and 2.48 mm (GII). No patient approached the
50% diameter stenosis at 1 year by angiography or IVUS assessment, and no edge restenosis was observed. Neointimal hyperplasia, as detected by IVUS, was virtually absent at 6 months (2±5% obstruction volume, GIII) and at 12 months (GI=2±5% and GII=2±3%).
Conclusions This study demonstrates a sustained suppression of neointimal proliferation by sirolimus-eluting Bx VELOCITY stents 1 year after implantation.
Key Words: angiography drugs stents restenosis ultrasonics
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