Optical coherence tomographic results at six-month follow-up evaluation of the CATANIA coronary stent system with nanothin Polyzene-F surface modification (from the Assessment of The LAtest Non-Thrombogenic Angioplasty Stent [ATLANTA] trial).

ABSTRACT

Drug-eluting stents were devised as an answer to restenosis, but research has shown that the eluting drug can interfere with the blood vessel's healing process, thus increasing the risk of stent thrombosis. A stent coated with the new proprietary polymer Polyzene-F, is a novel technical solution that promises to decrease in-stent restenosis and tackle the risk of thrombosis. Fifty-five patients were enrolled in the first clinical human study (ATLANTA registry), addressing the short-term follow-up results of the CATANIA stent with Polyzene-F. As a part of the study protocol, 15 patients were randomly assigned to optical coherence tomographic (OCT) examination at 6-month follow-up. Optical coherence tomograms were obtained using a Lightlab M2 system with a motorized pull-back at 2.0 mm/s. OCT images were acquired at 15.6 frames/s. A total of 1,904 cross-sectional images with 19,028 struts were analyzed. The rate of covered struts was 99.5%, whereas malapposed struts accounted for 0.15%. Area measurements were performed in 476 cross sections. Neointimal hyperplasia (NIH) area and percent NIH area were 3.2 +/- 1.4 mm2 and 38 +/- 17%, respectively. Percent NIH area was comparable between diabetics and nondiabetics. Qualitative assessment of OCT images demonstrated neither occurrence of stent fractures nor thrombus. In conclusion, OCT assessment of the Polyzene-F-covered stent at follow-up showed a small percentage of neointima. Also, almost complete stent strut coverage was revealed by optical coherence tomography. These figures indicate that the CATANIA stent with Polyzene-F is a promising solution for decreasing late stent restenosis and preventing thrombosis.