Comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularization a randomized controlled trial

JACC Cardiovasc Interv. 2011 Jun;4(6):672-82. doi: 10.1016/j.jcin.2011.02.017.

Abstract

Objectives: 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).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary*
  • Clopidogrel
  • Confidence Intervals
  • Coronary Angiography
  • Coronary Artery Disease / drug therapy*
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Myocardial Reperfusion / instrumentation
  • Myocardial Reperfusion / methods*
  • Platelet Aggregation Inhibitors / therapeutic use
  • Risk Factors
  • Sirolimus / analogs & derivatives*
  • Sirolimus / therapeutic use
  • Statistics as Topic
  • Statistics, Nonparametric
  • Switzerland
  • Ticlopidine / analogs & derivatives
  • Ticlopidine / therapeutic use
  • Titanium / therapeutic use*

Substances

  • Platelet Aggregation Inhibitors
  • titanium-nitride-oxide
  • Clopidogrel
  • Titanium
  • zotarolimus
  • Ticlopidine
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT00492908