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First-in-Man 1-Year Clinical Outcomes of the Catania Coronary Stent System With Nanothin Polyzene-F in De Novo Native Coronary Artery Lesions: The ATLANTA (Assessment of The LAtest Non-Thrombogenic Angioplasty stent) Trial.
- Source :
- JACC: Cardiovascular Interventions; Mar2009, Vol. 2 Issue 3, p197-204, 8p
- Publication Year :
- 2009
-
Abstract
- 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 ± 0.48 mm and the percent neointimal hyperplasia volume was 27.9 ± 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–defined 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. [Copyright &y& Elsevier]
- Subjects :
- MYOCARDIAL revascularization
CORONARY disease
TOMOGRAPHY
CROSS-sectional imaging
Subjects
Details
- Language :
- English
- ISSN :
- 19368798
- Volume :
- 2
- Issue :
- 3
- Database :
- Supplemental Index
- Journal :
- JACC: Cardiovascular Interventions
- Publication Type :
- Academic Journal
- Accession number :
- 37163158
- Full Text :
- https://doi.org/10.1016/j.jcin.2008.12.006