Randomized comparison of a titanium-nitride-oxide coated stent with a stainless steel Stent for coronary revascularization

Background - Stent coating with titanium- nitride- oxide has been shown to reduce neointimal hyperplasia in the porcine restenosis model. We designed a prospective, randomized, clinical study to investigate the safety and efficacy of titanium- nitride- oxide - coated stents compared with stainless steel stents. Methods and Results - Ninety- two patients with de novo lesions were randomly assigned to treatment with titanium nitrideoxide - coated stents ( n =45) or stainless steel stents of otherwise identical design ( n = 47; control). Baseline characteristics were similar in both groups. At 30 days, no stent thromboses or other adverse events had occurred in either group. Quantitative coronary angiography at 6 months revealed lower late loss ( 0.55 +/- 0.63 versus 0.90 +/- 0.76 mm, P = 0.03) and percent diameter stenosis ( 26 +/- 17% versus 36 +/- 24%, P = 0.04) in lesions treated with titanium- nitride oxide - coated than in control stents. Binary restenosis was reduced from 33% in the control group to 15% in the titanium- nitride oxide - coated stent group ( P = 0.07). Intravascular ultrasound studies at 6 months showed smaller neointimal volume in titanium- nitride- oxide - coated stents than in control stents ( 18 +/- 21 versus 48 +/- 28 mm(3), P < 0.0001). Major adverse cardiac events at 6 months were less frequent in titanium- nitride- oxide - coated stents than in control stent - treated patients ( 7% versus 27%, P = 0.02), largely driven by a reduced need for target- lesion revascularization ( 7% versus 23%, P = 0.07). Conclusions - Revascularization with titanium- nitride- oxide - coated stents is safe and effective in patients with de novo native coronary artery lesions. Titanium- nitride- oxide - coated stents reduce restenosis and major adverse cardiac events compared with stainless steel stents of otherwise identical design.