Initial and follow-up results of the Tenax coronary stent.
The Tenax coronary stent is laser sculpted from high precision 316 L stainless steel using advanced production procedures. An a-SiC: H (hydrogen-rich amorphous silicon carbide) coating reduces its thrombogenicity and improves its biocompatibility. From April to July 1998, 266 stents were implanted in 241 patients (aged 62.7 +/- 10.5 years) in five centers. The clinical indication for intervention was unstable angina (33.2%) and recent myocardial infarction (29.5%) in many cases. Most lesions (53.8%) had complex characteristics (Class B2 or C). The target vessel was the LAD in 42.5% and the right coronary artery in 36.8% of all cases. Four primary stent deployment failures occurred and implantation was successful in 259 (97.4%) of 266 stents. No death and no Q-wave myocardial infarction or emergency CABG occurred during hospital stay. Clinical success, defined as successful deployment without procedural or clinical event, was achieved in 230 (95.4%) of 241 patients. One-year clinical follow-up shows a low need for target lesion revascularization (17/237 [7.1%] patients) and a 15.8% rate of major adverse cardiac events (36/237 patients). The clinical and angiographic outcomes of our study suggest that the hybrid, amorphous hydrogenated silicon carbide coated design is promising and merits further evaluation in larger clinical trials.
Carrié
D
D
Service de Cardiologie, CHU Purpan, Place du Dr Baylac, 31059 Toulouse, France.
Khalifé
K
K
Hamon
M
M
Citron
B
B
Monassier
J P
JP
Sabatier
R
R
Lipiecky
J
J
Mourali
S
S
Sarfaty
L
L
Elbaz
M
M
Fourcade
J
J
Puel
J
J
D000368:Aged; D000789:Angina, Unstable / Q000628:therapy*; D001672:Biocompatible Materials; D017554:Carbon Compounds, Inorganic; D020099:Coated Materials, Biocompatible; D003331:Coronary Vessels; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D017655:Silicon Compounds; D013193:Stainless Steel; D015607:Stents
D001672:Biocompatible Materials; D017554:Carbon Compounds, Inorganic; D020099:Coated Materials, Biocompatible; D017655:Silicon Compounds; D013193:Stainless Steel; C022088:silicon carbide