Comparison of a silicon carbide coated stent versus a noncoated stent in humans: the Tenax- versus Nir-Stent Study (TENISS).
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.
Unverdorben
Martin
M
Center for Cardiovascular Diseases, Heinz-Meise-Strasse 100, Rotenburg a. d. Fulda, Germany. camus.hkz.rotenburg@t-online.de
Sattler
Katherine
K
Degenhardt
Ralf
R
Fries
Roland
R
Abt
Bernd
B
Wagner
Eberhard
E
Koehler
Henning
H
Scholz
Manfred
M
Ibrahim
Hassan
H
Tews
Karl-Heinz
KH
Hennen
Benno
B
Daemgen
Gabriele
G
Berthold
Heiner K
HK
Vallbracht
Christian
C
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
D017554:Carbon Compounds, Inorganic; D017655:Silicon Compounds; C022088:silicon carbide