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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

Corrado Tamburino, MD, PhD, FESC, FSCAI, FSICI-GISE^_*,_*, Alessio La Manna, MD^_*, Maria Elena Di Salvo, MD^_*, Giorgio Sacchetta, MD^_*, Davide Capodanno, MD^_*, Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FSCAI, George Dangas, MD, PhD, FACC, FSCAI, FAHA, Thierry Corcos, MD, FACC, FESC, FSCAI, Francesco Prati, MD, FESC

^_* Cardiology Department, Ferrarotto Hospital, University of Catania, Catania, Italy
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Department of Interventional Cardiology, Clinique Turin, Paris, France
Interventional Cardiology and Rome Heart Research, San Giovanni Hospital, Rome, Italy

^_* Reprint requests and correspondence: Dr. Corrado Tamburino, Director Postgraduate School of Cardiology, Chair of Cardiology, Director University-Hospital Cardiology Unit, Chief Cardiovascular Department, Ferrarotto Hospital, University of Catania, via Citelli 6, 95124 Catania, Italy (Email: tambucor{at}unict.it).

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.

Key Words: nonpolymeric coating • first in man • optical coherence tomography

Abbreviations and Acronyms   BMS = bare-metal stent(s)   BR = binary restenosis   DAPT = dual antiplatelet therapy   DES = drug-eluting stent(s)   FIM = first-in-man   IVUS = intravascular ultrasound   LLL = late lumen loss   MI = myocardial infarction   MLD = minimal lumen diameter   NIHV = neointimal hyperplasia volume   OCT = optical coherence tomography   QCA = quantitative coronary angiography   ST = stent thrombosis   TLR = target lesion revascularization   TVR = target vessel revascularization