ATLANTA trial results are published


Twelve-month data from the ATLANTA trial were published in the latest issue of the Journal of the American College of Cardiology: Cardiovascular Interventions. According to the data, the Catania coronary stent system with NanoThin Polyzene-F offers sustained benefit in the treatment of de novo coronary lesions and maximises endothelialisation, while reducing restenosis, thrombogenicity, and the need for long-term dual-antiplatelet therapy. The device may be an alternative to both bare metal and drug-eluting stent.

The ATLANTA Trial is a first-in-man, prospective, single center study involving 55 patients treated with the Catania Stent for symptomatic ischemic heart disease due to de novo, obstructive lesions of native coronary arteries. The trial was sponsored by CeloNova BioSciences, manufacturer of the Catania stent.

At 12 months, in an unusually complex FIM patient population, the results showed zero percent stent thrombosis, death, myocardial infarction, stroke, or coronary artery bypass graft. Target lesion revascularisation was 10.9% (only 3.6% clinically driven), with a binary restenosis rate of 6.8%. All patients stopped dual anti-platelet therapy after 30 days. The procedural success rate was 100%.

Independent laboratories analysed coronary angiography and intravascular ultrasound data for all patients immediately after stent implantation and at 6-months. Analysis of 19,028 struts using optimal coherence tomography in a subset of 15 randomly selected patients revealed complete endothelialisation and 99.5% stent strut coverage.

“CeloNova has started a scientific revolution involving the way physicians think about bare metal stents and drug-eluting stents. I can definitely assert that Polyzene-F is innovative, effective in several aspects, unique and striking. The polymer is, without any doubt, the main reason for the great results we have obtained which is why I chose the Catania stent to implant in my very best friend,” said Dr Corrado Tamburino, Ferrarotto Hospital, Catania, Italy, and lead investigator in the ATLANTA trial. “The 12-month ATLANTA data indicate that the Catania stent with Polyzene-F is truly a new and promising class of stent.”

The rapid-exchange, cobalt-chromium Catania stent is currently available for sale in Europe in 60 sizes, in lengths from 8-38mm and in diameters from 2-4mm. The Catania stent surface has a 35-40 nanometer surface treatment of Polyzene-F, an inorganic, biocompatible polymer that is antithrombotic, anti-inflammatory, bacterial-resistant, lubricious, and essentially cloaks the device’s presence from the body to promote healthy endothelial cell growth without stimulating platelet activation.