WASHINGTON, Oct. 13 -- Clinical investigators at today's "Innovative Devices and Futuristic Therapies" session during the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, presented 12-month follow-up data from the ATLANTA Trial. The results include zero percent thrombosis in patients discontinuing dual anti-platelet therapy after only 30 days.
The ATLANTA Trial is a first-in-man (FIM), prospective, single center, non-randomized, single-arm study involving 55 patients (76 lesions) treated with the CATANIA™ Coronary Stent System with NanoThin Polyzene®-F surface modification for symptomatic ischemic heart disease due to de novo, obstructive lesions of native coronary arteries. The trial was sponsored by CeloNova BioSciences, Inc., maker of the CATANIA™ stent.
At 12 months, in an unusually complex FIM patient population, the results showed zero (0.0) percent stent thrombosis (Academic Research Consortium, or ARC-defined), death, myocardial infarction, stroke, or coronary artery bypass graft. Target lesion revascularization was 10.9 percent (only 3.6 percent clinically driven, 7.3 percent non-clinically driven), with a binary restenosis rate of 6.8 percent (five of 74 lesions analyzed at twelve months). Of note, all patients stopped dual anti-platelet therapy after 30 days, but continued aspirin (100 mg/d) throughout the 12-month period.
The acute angiographic and procedural success rate in the ATLANTA Trial was 100 percent. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound (IVUS) data for all patients immediately after stent implantation and at 6-month follow-up. Further analysis of 1,904 cross sections (19,028 struts) by investigators using Optimal Coherence Tomography at baseline and again at 6-month follow-up in a subset of 15 randomly selected patients revealed complete endothel
|Contact: David Patti|
The Storch Murphy Group