Silicon Carbide Coating Ñ A Semiconducting Hybrid Design of Coronary Stents Ñ A Feasibility Study

OBJECTIVE: To determine the rates of subacute and acute thrombotic stent occlusion in patients with normal and high risk for stent thrombosis and to assess the 6 month follow-up with respect to in-stent restenosis, using a new principle of semiconductor coating (active passivating as metallic hybrid design). DESIGN: Open, non-randomized, prospective, observational, feasibility study. PATIENTS: One hundred sixty-five patients (215 stents) were scheduled consecutively with respect to lesions suitable for slotted tube stent implantation. Two subgroups of patients (stents) were identified based on the local thrombotic risk (common indications for stent implantation Ñ group I; lesions with high(er) risk for stent implantation (group II). A closed clinical 3Ð12 (mean 6.5 +/- 2.3) months follow-up was done in 126 (92.6%) eligible patients [164 (97.6%) stents]. Angiographic and/or IVUS data were available in 96 of 136 eligible patients (70.6%) after stenting 6.0 +/- 2.1 months). STENT-MATERIAL/MEDICATION: Balloon expandable tantalum three segment slotted tube stents which were coated with silicon carbide, diameter ranged from 2.5 to 4.0 mm were used. Stent deployment was limited by inflation pressure (12Ð16 Bar). Apart from patients with acute myocardial infarction (n = 15 stents) patients received heparin loading dose during the procedure only, no oral anticoagulation except aspirin (300 mg p.d.) and ticlopidine (250Ð500mg p.d.) given over 1 month. RESULTS: Acute complications. No in-hospital mortality occurred, stent-related myocardial infarction was 1.9%; major bleedings 0.5% of implanted stents. Acute stent thrombosis 1.4%, subacute stent thrombosis occurred in 0.5% (no significant difference between group I and II). Late events: From 136 eligible patients (range 15 daysÐ14 months) (187 stents) 92 patients (67.6%) with 142 stents (75.9%) were event-free. In-stent restenosis. Thirty-six percent (biased group of patients with events) resp. 26.8% (including negative clinical events) of the implanted stents were restenosed. An inverse relationship between vessel size and in-stent (re)stenosis was observed. CONCLUSIONS: Silicon-carbide coated coronary stents are suitable in standard as well as in high-risk situations. The rates for acute or subacute stent thrombosis are acceptably low even when using post-procedural conventional (aspirin/ticlopidine) anti-thrombotic medication in patients who are at high risk for stent thrombosis. An inverse relationship exists between stent-restenosis rate and the size of the reference segment of the implanted vessel.