Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries
2001; Lippincott Williams & Wilkins; Volume: 103; Issue: 2 Linguagem: Inglês
10.1161/01.cir.103.2.192
ISSN1524-4539
AutoresJ. Eduardo Sousa, Marco A. Costa, Alexandre Abizaid, Alexandre Abizaid, Fausto Feres, Ibraim Pinto, Ana C. Seixas, Rodolfo Staico, Luiz Alberto Mattos, Amanda G.M.R. Sousa, Robert Falotico, Judith Jaeger, Jeffrey J. Popma, Patrick W. Serruys,
Tópico(s)Integrated Circuits and Semiconductor Failure Analysis
ResumoBackground —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.
Referência(s)