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Preliminary results from the first-in-man study EXCELLA

BACKGROUND: Stent restenosis suffered a marked reduction with drug-eluting stents (DES) reaching levels below 10% in most clinical and angiographic scenarios. Since then, new devices with different drugs have been tested in order to obtain an efficiency equivalent to first generation DES (Cypher® and Taxus®), although with better long-term safety. Our objective was to evaluate safety and neointimal proliferation inhibition with novolimuseluting stent through clinical and angiographic endpoints. METHODS: Single-center, first-in-man study, including 15 patients with angina pectoris submitted to novolimuseluting stent implantation. RESULTS: Angiographic analysis with quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) performed immediately after stent implantation and at 4-month follow-up revealed instent and in-segment late loss of 0.15 mm ± 0.29 mm and 0.07 mm ± 0.3 mm, respectively. In-stent volume obstruction was 2.6 ± 2.6%. No cases of binary restenosis were observed. The six-month clinical follow-up revealed no major acute cardiovascular events (MACE). CONCLUSION: The new novolimus-eluting stent proved to be efficient in reducing late loss and supressing neointimal proliferation. Late results in more complex group of patients are needed to confirm the safety of this new device.

Stents; Coronary disease; Ultrasonography, interventional; Coronary angiography; Coated materials, biocompatible; Drug implants


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