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Publications (1)1.5 Total impact

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    ABSTRACT: Purpose:Stents coated with hypothrombogenic silicon carbide (a-SiC:H) exhibited low restenosis rates in the rabbit and in an observational study in humans. Thus, the clinical and angiographic outcome was assessed in a large multicenter study. Material and Methods: Four hundred and ninety-seven patients (63.4 ± 9.8 years) were randomized to either receive the a-SiC:H-coated Tenax™ stent or the stainless steel Nir™ stent. Lesions (diameter ≥2.8 mm, length <20 mm) were covered with one single stent. Results: Fifty-one of 497 (10.3%) patients were excluded for protocol violation. Three hundred and forty-two of 446 (76.7%) patients presented for scheduled angiographic follow-up after 4.7 ± 1.2 months and 29 of 446 (6.5%) prematurely. In-hospital complications comprised two deaths (0.8%) (P > 0.99) and one (0.4%) (P > 0.99) CK-elevation in each group, target lesion revascularization in 5 of 250 (2%) of the Tenax™ and 4 of 244 (1.6%) of the Nir™ sample (P > 0.99), and subacute thrombosis in 2 of 250 (0.8%) of the Tenax™ patients (P = 0.5). In the Tenax™/Nir™ patients mean percent diameter stenosis decreased from 82.3 ± 9.1%/80.7 ± 8.4% (P = 0.49) to 17.6 ± 5.5%/17.6 ± 5.5% (P = 0.99) postprocedure and increased to 34.5 ± 21.5%/34.2 ± 23.1% (P = 0.90) at follow-up. Conclusions: Thus, there appears to be no advantage of the silicon carbide coated stent over a stainless steel stent after 4.7 ± 1.2 months with regard to clinical and angiographic restenosis rates. (J Interven Cardiol 2003;16:325–333)
    Journal of Interventional Cardiology 07/2003; 16(4):325 - 333. · 1.50 Impact Factor

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3 Citations
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1.50 Total Impact Points

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