title: Comparison of a silicon carbide coated stent versus a noncoated stent in humans: the Tenax- versus Nir-Stent Study (TENISS).
abstract: OBJECTIVE
  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.
  
  
  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 > or = 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.
authors.affiliation: Center for Cardiovascular Diseases, Heinz-Meise-Strasse 100, Rotenburg a. d. Fulda, Germany. camus.hkz.rotenburg@t-online.de
authors.forename: Martin
authors.initials: M
authors.lastname: Unverdorben
authors.forename: Katherine
authors.initials: K
authors.lastname: Sattler
authors.forename: Ralf
authors.initials: R
authors.lastname: Degenhardt
authors.forename: Roland
authors.initials: R
authors.lastname: Fries
authors.forename: Bernd
authors.initials: B
authors.lastname: Abt
authors.forename: Eberhard
authors.initials: E
authors.lastname: Wagner
authors.forename: Henning
authors.initials: H
authors.lastname: Koehler
authors.forename: Manfred
authors.initials: M
authors.lastname: Scholz
authors.forename: Hassan
authors.initials: H
authors.lastname: Ibrahim
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Tews
authors.forename: Benno
authors.initials: B
authors.lastname: Hennen
authors.forename: Gabriele
authors.initials: G
authors.lastname: Daemgen
authors.forename: Heiner K
authors.initials: HK
authors.lastname: Berthold
authors.forename: Christian
authors.initials: C
authors.lastname: Vallbracht
mesh_terms: D017554:Carbon Compounds, Inorganic; D003327:Coronary Disease / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D017655:Silicon Compounds; D015607:Stents
chemical_list: D017554:Carbon Compounds, Inorganic; D017655:Silicon Compounds; C022088:silicon carbide