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Cobalt-Chromium Stent With "Cloak" Coating Significantly Reduces Restenosis: Presented at ISET

By Thomas Collins

HOLLYWOOD, Fla -- January 25, 2009 -- The combination of a cobalt-chromium stent and a stent-cloaking chemical compound coating (Polyzene-F) continues to generate encouraging results in a "first-in-man" study taking place in Italy, researchers noted at the 21st International Symposium on Endovascular Therapy (ISET).

"The surface modification of the stent by the [coating] allows [the patient] to get some positive effects," noted Corrado Tamburino, MD, PhD, Ferrarotto Hospital, University of Catania, Catania, Sicily, Italy.

After 12 months with the coated stent, none of the 55 patients in the study experienced stent thrombosis (as defined by the Academic Research Consortium). No patient had a heart attack or died either, added Dr. Tamburino. "The absence of thrombosis is one of the most important features of this study," he noted at an oral presentation here on January 22.

Target-lesion revascularisation brought about by clinical work was experienced by 2 patients (3.6%) after 12 months.

Dr. Tamburino said the extremely thin coating is "highly biocompatible." It has been touted as extremely slick, allowing these stents to be moved into place more easily than bare-metal stents. The coating also allows the cobalt-chromium stent to work while remaining free from platelet attacks, Dr. Tamburino explained, because the coating allows the stent to remain unidentified by the body. "This stent is not thick, is not sticky, doesn't crack, and doesn't break," he stated.

The patient population in this study had "very complex clinical characteristics," the researchers noted. There were 76 lesions among the 55 patients. Eight patients had type A lesions, 53 had type B, and 15 had type C. All patients stopped dual antiplatelet therapy after 30 days, but continued aspirin (100 mg/d) throughout the 12-month period.

After 6 months, late lumen loss averaged 0.60 mm and the neointimal hyperplasia volume was 27.9%.

After 12 months, stents in 15 randomly chosen patients were analysed using optical coherence tomography. In that analysis, only 29 of the 19,028 struts were malapposed. Binary angiographic restenosis was recorded in 6.8% of these patients.

Researchers were so pleased with the results from this first-in-man study that all of the bare-metal stents in patients at Ferrarotto Hospital were replaced with the coated cobalt-chromium stents. That replacement encompassed 233 patients with 312 lesions.

The results among those patients have been encouraging so far. Target-lesion revascularisation has been required in 12 of the patients (5.1%), Dr. Tamburino noted. There have been 2 cardiac deaths, both due to severe aortic stenosis, and there has also been 1 heart attack, apparently caused by inadequate stent expansion and residual dissection.

"[These] coated stents may be an alternative to both bare-metal stents and drug-eluting stents," Dr. Tamburino reported, "with reduced late lumen loss and restenosis, and target-lesion revascularisation without long-term dual antiplatelet therapy."

[Presentation title: First-in-Man One-Year Clinical Outcomes of the CATANIA Coronary Stent System With NanoThin Polyzene-F in De Novo Native Coronary Artery Lesions: Assessment of the Latest Non-Thrombogenic Angioplasty Stent (ATLANTA) Trial.]

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