- 作者：Corrado Tamburino ; MD ; PhD ; FESC ; FSCAI ; FSICI-GISE?/sup> ; tambucor@unict.it ; Alessio La Manna ; MD?/sup> ; Maria Elena Di Salvo ; MD?/sup> ; Giorgio Sacchetta ; MD?/sup> ; Davide Capodanno ; MD?/sup> ; Roxana Mehran ; MD ; FACC ; FACP ; FCCP ; FESC ; FSCAI&dagger ; ; George Dangas ; MD ; PhD ; FACC ; FSCAI ; FAHA&dagger ; ; Thierry Corcos ; MD ; FACC ; FESC ; FSCAI&Dagger ; ; Francesco Prati ; MD ; FESC§ ;
- 关键词：nonpolymeric coating ; first in man ; optical coherence tomography
- 刊名：JACC: Cardiovascular Interventions
- 出版年：2009
- 出版时间：March 2009
- 年：2009
- 卷：2
- 期：3
- 页码：197-204
- 全文大小：139 K
Objectives
This study sought to assess safety and efficacy of implantation of the Catania Coronary Stent System with Nanothin Polyzene-F (CeloNova BioSciences, Newnan, Georgia) in human coronary arteries with clinical data and comprehensive intracoronary imaging.Background
Novel approaches to modify stents (e.g., bioactive agents, coatings) have been developed to address the limitations of bare-metal and drug-eluting stents (e.g., restenosis, target lesion revascularization [TLR], late thrombosis).
Methods
This first-in-man study using the Catania stent is a prospective, single center, nonrandomized, single-arm study of 55 patients with symptomatic ischemic heart disease with de novo, obstructive lesions of native coronary arteries.
Results
Acute angiographic success was 100 % . A core laboratory analyzed quantitative coronary angiography and intravascular ultrasound data immediately after stenting and at 6-month follow-up. Late lumen loss was 0.60 ¡À 0.48 mm and the percent neointimal hyperplasia volume was 27.9 ¡À 16.1 % . In 15 of 55 randomly selected patients, 1,904 cross-sections (19,028 struts) were analyzed at 6 months by optical coherence tomography. Overall, 99.5 % of struts were covered. Only 29 of 19,028 struts (0.15 % ) were malapposed. Binary angiographic restenosis was 6.8 % . No death, myocardial infarction, or Academic Research Consortium¨Cdefined stent thrombosis was observed at 12 months. The incidence of TLR at 12 months was clinically driven TLR 3.6 % (2 of 55) and nonclinically driven TLR 7.3 % (4 of 55).
Conclusions
This first-in-man showed an excellent early and mid-term safety profile and high-level efficacy of the new Catania stent in the treatment of de novo coronary lesions in a fairly complex population. Polyzene-F coated stents may be an alternative to both bare-metal and drug-eluting stents with reduced late loss, restenosis, and the TLR without long-term dual antiplatelet therapy.