Randomised comparison of titanium-nitride-oxide coated stents with bare metal stents: five year follow-up of the TiNOX trial.
Revascularisation with Titanium-Nitride-Oxide (TiNOX) coated stents is safe and effective in patients with de novo native coronary artery lesions. In the TiNOX trial there was a reduction in restenosis and major adverse cardiac events as compared with stainless steel stents of otherwise identical design. The purpose of the present study was to evaluate the long-term outcome of these patients over five years.



In 2003, 92 patients with de novo lesions were randomly assigned to treatment with TiNOX coated stents (n=45) or stainless steel stents (n=47; control). Baseline characteristics were similar in both groups. Follow-up at six months and five years was obtained in 87 patients. Five patients were lost to follow-up due to emigration or change in home address. At six months and five years, significantly less major adverse cardiac events (MACE) occurred in the TiNOX group (7% vs. 27%, [p=0.02] respectively and 16% vs. 39%, [p=0.03]), largely driven by a reduced need for target-lesion revascularisation. No stent thrombosis occurred in the TiNOX group vs. one in the control group. Patients in the TiNOX-group had lower all-cause mortality and less myocardial infarction, but the difference was not statistically significant.



Five-year follow-up after implantation of titanium-nitride-oxide coated stents is favourable with a low rate of MACE and no stent thrombosis compared to bare metal stents of identical design. The need for revascularisation at five years was 9% in the TiNOX and 25% in the control group with little progression of native coronary disease.
Moschovitis
Aris
A
Department of Cardiology, Swiss Cardiovascular Center, University Hospital Bern, Switzerland.
Simon
Rüdiger
R
Seidenstücker
Antje
A
Klauss
Volker
V
Baylacher
Monika
M
Lüscher
Thomas F
TF
Moccetti
Tiziano
T
Windecker
Stephan
S
Meier
Bernhard
B
Hess
Otto M
OM
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D011474:Prosthesis Design; D013193:Stainless Steel; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D014025:Titanium; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; C434243:titanium-nitride-oxide; D013193:Stainless Steel; D014025:Titanium