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Randomized intravascular ultrasound comparison between endoprostheses with and without amorphous silicon-carbide

OBJECTIVE: In-stent restenosis remains a major limitation following coronary stent implantation. Amorphous silicon-carbide (a-SiC) coating has been shown to improve stent biocompatibility, therefore, reducing local inflammation and thrombus generation. Due to the latter, a-SiC coating might have an impact on the prevention of neointimal hyperplasia (NIH) and restenosis. METHODS: This prospective, randomized, open-label trial compared a-SiC-coated (group A) versus uncoated (group B) stent implantation in de novo lesions. We included 100 patients (50 patients in each group) and the primary end-point was in-stent volume of NIH measured by intravascular ultrasound. RESULTS: All patients underwent successful stent deployment. Although absolute NIH volume was greater in A (51.2 mm³ SD 18.8 mm³ versus 41.9 mm³ SD 16.4 mm³; P = 0.014), relative (divided per mm of stent length) NIH volume was similar (2.9 mm³/mm stent SD 1.0 mm³/mm stent versus 2.5 mm³/mm stent SD 0.9 mm³/mm stent; P = 0.108). Late loss, restenosis, and major adverse cardiac events (MACE) were similar. CONCLUSION: A-SiC-coated stents did not reduce either NIH or MACE at long-term follow-up.

restenosis; coronary artery disease; percutaneous coronary intervention


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