Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study
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 >or=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.
|Keywords||*Coated Materials, Biocompatible, *Immunosuppressive Agents, *Sirolimus, *Stents, Aged, Arteries, Coronary Angiography, Coronary Restenosis/*prevention & control, Coronary Vessels/*surgery/ultrasonography, Delayed-Action Preparations, Feasibility Studies, Female, Humans, Male, Middle aged, Pilot Projects, Research Support, Non-U.S. Gov't, Treatment Outcome, Tunica Intima/radiography/*surgery/ultrasonography, Ultrasonography, Interventional, angioplasty, restenosis, stents|
Sousa, J.E., Feres, F., Pinto, I.M.F., Seixas, A.C., Staico, R., Mattos, L.A., … Abizaid, A.C.. (2001). Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study. Circulation (Baltimore), 103(2), 192–195. Retrieved from http://hdl.handle.net/1765/9593
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