(Circulation. 2001;103:192.)
© 2001 American Heart Association, Inc.
Clinical Investigation and Reports |
Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries
A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study
From the Institute Dante Pazzanese of Cardiology, São Paulo, Brazil (J.E.S., M.A.C., A.A., A.S.A., F.F., I.M.F.P., A.C.S., R.S., L.A.M., A.G.M.R.S.); 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 diretoriaidpc{at}uol.com.br
Background—Restenosis remains an important limitation of interventional cardiology. Therefore, we aimed to determine the safety and efficacy of sirolimus (a cell-cycle inhibitor)-coated BX Velocity stents.
Methods and
Results—Thirty patients with angina pectoris
were electively treated with 2 different formulations of
sirolimus-coated stents (slow release [SR], n=15, and fast release
[FR], n=15). All stents were successfully delivered, and patients
were discharged without clinical complications. Independent core
laboratories analyzed angiographic and 3D volumetric intravascular
ultrasound data (immediately after procedure and at 4-month follow-up).
Eight-month clinical follow-up was obtained for all patients. There was
minimal neointimal hyperplasia in both groups (11.0±3.0% in the SR
group and 10.4±3.0% in the FR group,
P=NS) by ultrasound and
quantitative coronary angiography (in-stent late loss, 0.09±0.3 mm
[SR] and -0.02±0.3 mm [FR]; in-lesion late loss, 0.16±0.3 mm
[SR] and -0.1±0.3 mm [FR]). No in-stent or edge restenosis
(diameter stenosis 
50%) was observed. No major clinical events
(stent thrombosis, repeat revascularization, myocardial infarction, or
death) had occurred by 8 months.
Conclusions—The implantation of sirolimus-coated BX Velocity stents is feasible and safe and elicits minimal neointimal proliferation. Additional placebo-controlled trials are required to confirm these promising results.
Key Words: stents • restenosis • angioplasty
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