PURPOSE: To report the results of a prospective, nonrandomized, multicenter study of a semiconductor-coated stent in coronary lesions at high risk for stent thrombosis. METHODS: A balloon-expandable tantalum stent was coated with silicon carbide to enhance thromboresistance (Tensum). Patients were enrolled in an observational study that compared coronary stenting with the Tensum stent in patients at low risk for stent thrombosis against those with factors predisposing to local thrombosis (acute myocardial infarction, small vessel diameter, recanalized chronic total occlusion, saphenous vein bypass grafts, and coronary allograft vascular disease). RESULTS: In 294 patients with 364 coronary lesions, 111 patients with 142 lesions were assigned to the high-risk group. Overall, 406 Tensum stents were implanted (94% procedural success) using antiplatelet medication only after the procedure. The stent thrombosis rate (2.7% overall) in the high-risk group (3.6%) was not significantly different from that of the low-risk patients (2.1%). CONCLUSIONS: Silicon carbide coating on coronary stents may inhibit acute/subacute stent thrombosis even in patients at high risk. Randomized trials are underway for further evaluation of this promising coated stent.
PURPOSE: To report the results of a prospective, nonrandomized, multicenter study of a semiconductor-coated stent in coronary lesions at high risk for stent thrombosis. METHODS: A balloon-expandable tantalum stent was coated with silicon carbide to enhance thromboresistance (Tensum). Patients were enrolled in an observational study that compared coronary stenting with the Tensum stent in patients at low risk for stent thrombosis against those with factors predisposing to local thrombosis (acute myocardial infarction, small vessel diameter, recanalized chronic total occlusion, saphenous vein bypass grafts, and coronary allograft vascular disease). RESULTS: In 294 patients with 364 coronary lesions, 111 patients with 142 lesions were assigned to the high-risk group. Overall, 406 Tensum stents were implanted (94% procedural success) using antiplatelet medication only after the procedure. The stent thrombosis rate (2.7% overall) in the high-risk group (3.6%) was not significantly different from that of the low-risk patients (2.1%). CONCLUSIONS:Silicon carbide coating on coronary stents may inhibit acute/subacute stent thrombosis even in patients at high risk. Randomized trials are underway for further evaluation of this promising coated stent.