Clinical outcome of titanium-nitride-oxide-coated cobalt-chromium stents in patients with de novo coronary lesions: 12-month results of the OPTIMAX first-in-man study

Catheter Cardiovasc Interv. 2016 Mar;87(4):E122-7. doi: 10.1002/ccd.26104. Epub 2015 Aug 26.

Abstract

Objectives: We explored the 12-month clinical outcome of the titanium-nitride-oxide-coated OPTIMAX stent based on cobalt-chromium platform.

Background: The OPTIMAX stent demonstrated a satisfactory 6-month clinical outcome in de novo coronary lesions.

Methods: We enrolled 224 consecutive symptomatic patients with significant (50%) stenosis in de novo coronary lesions, who were treated with OPTIMAX stent implantation. The primary endpoint was major adverse cardiac events at 12-month follow-up, defined as a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Stent thrombosis was adjudicated according to the definition of the Academic Research Consortium.

Results: The mean age of the cohort was 67 ± 8 years (75% males). Patients presented with acute coronary syndrome in 62.1%. Radial access was used in 92%; complex (type B and C) lesions were treated in 79.9%. Both procedural and clinical success occurred in 100% of the cases. The mean follow-up period was 366 ± 22 days. At 12-month follow-up, the primary endpoint occurred in 14 (6.3%) patients. Cardiac death occurred in three (1.3%) patients, non-fatal MI in seven (3.1%) patients, and ischemia-driven TLR in seven (3.1%) patients. No definite stent thrombosis occurred.

Conclusions: In the current prospective observational study, implantation of the OPTIMAX stent demonstrated an adequate 12-month clinical outcome, with a low rate of major adverse cardiac events, and no stent thrombosis.

Keywords: cobalt-chromium; percutaneous coronary intervention; stent thrombosis; titanium-nitride-oxide.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Chromium Alloys*
  • Coated Materials, Biocompatible*
  • Coronary Angiography
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / mortality
  • Coronary Stenosis / therapy*
  • Coronary Thrombosis / etiology
  • Coronary Thrombosis / mortality
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology
  • Myocardial Infarction / mortality
  • Oxides*
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Prospective Studies
  • Prosthesis Design
  • Risk Factors
  • Stents*
  • Time Factors
  • Titanium*
  • Treatment Outcome

Substances

  • Chromium Alloys
  • Coated Materials, Biocompatible
  • Oxides
  • titanium nitride
  • Titanium