title: Comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularization a randomized controlled trial.
abstract: OBJECTIVE
  This study sought to compare the efficacy of passive stent coating with titanium-nitride-oxide (TiNO) with drug-eluting stents releasing zotarolimus (ZES) (Endeavor, Medtronic, Minneapolis, Minnesota).
  
  
  BACKGROUND
  Stent coating with TiNO has been shown to reduce restenosis compared with bare-metal stents in experimental and clinical studies.
  
  
  METHODS
  In an assessor-blind noninferiority study, 302 patients undergoing percutaneous coronary intervention were randomized to treatment with TiNO or ZES. The primary endpoint was in-stent late loss at 6 to 8 months, and analysis was by intention to treat.
  
  
  RESULTS
  Both groups were well balanced with respect to baseline clinical and angiographic characteristics. The TiNO group failed to reach the pre-specified noninferiority margin for the primary endpoint (in-stent late loss: 0.64 ± 0.61 mm vs. 0.47 ± 0.48 mm, difference: 0.16, upper 1-sided 95% confidence interval [CI]: 0.26; p(noninferiority) = 0.54), and subsequent superiority testing was in favor of ZES (p(superiority) = 0.02). In-segment binary restenosis was lower with ZES (11.1%) than with TiNO (20.5%; p(superiority) = 0.04). A stratified analysis of the primary endpoint found particularly pronounced differences between stents among diabetic versus nondiabetic patients (0.90 ± 0.69 mm vs. 0.39 ± 0.38 mm; p(interaction) = 0.04). Clinical outcomes showed a similar rate of death (0.7% vs. 0.7%; p = 1.00), myocardial infarction (5.3% vs. 6.7%; p = 0.60), and major adverse cardiac events (21.1% vs. 18.0%, hazard ratio: 1.19, 95% CI: 0.71 to 2.00; p = 0.50) at 1 year. There were no differences in rates of definite or probable stent thrombosis (0.7% vs. 0%; p = 0.51) at 1 year.
  
  
  CONCLUSIONS
  Compared with TiNO, ZES was superior with regard to late loss and binary restenosis. The concept of passive stent coating with TiNO remains inferior to drug-eluting stent technology in reducing restenosis. ([TIDE] Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent: NCT00492908).
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.forename: Lorenz
authors.initials: L
authors.lastname: Räber
authors.forename: Andreas
authors.initials: A
authors.lastname: Limacher
authors.forename: Lukas
authors.initials: L
authors.lastname: Löffel
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.forename: Stéphane
authors.initials: S
authors.lastname: Cook
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Stauffer
authors.forename: Mario
authors.initials: M
authors.lastname: Togni
authors.forename: Rolf
authors.initials: R
authors.lastname: Vogel
authors.forename: Ali
authors.initials: A
authors.lastname: Garachemani
authors.forename: Aris
authors.initials: A
authors.lastname: Moschovitis
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Khattab
authors.forename: Christian
authors.initials: C
authors.lastname: Seiler
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000077144:Clopidogrel; D016001:Confidence Intervals; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000188:drug therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015425:Myocardial Reperfusion / Q000295:instrumentation / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D012307:Risk Factors; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013223:Statistics as Topic; D018709:Statistics, Nonparametric; D013557:Switzerland; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D014025:Titanium / Q000627:therapeutic use*
chemical_list: D010975:Platelet Aggregation Inhibitors; C434243:titanium-nitride-oxide; D000077144:Clopidogrel; D014025:Titanium; C489443:zotarolimus; D013988:Ticlopidine; D020123:Sirolimus