French Ministry of Health prospective multicentre study using bio-active stents coated with titanium nitride oxide: the EVIDENCE registry

Arch Cardiovasc Dis. 2012 Feb;105(2):60-7. doi: 10.1016/j.acvd.2011.12.003. Epub 2012 Feb 19.

Abstract

Background: Coronary stents have evolved over time, from bare-metal stents to drug-eluting stents, and now to bioactive stents.

Aims: We sought to explore the immediate outcome of the titanium-nitride-oxide-coated bioactive stent, Titan2(®), in real-world practice, and the incidence of major cardiac events at follow-up.

Methods: Consecutive patients admitted for percutaneous intervention for at least one significant (≥50%) lesion in a native coronary artery were treated with Titan2(®) stent implantation. The primary endpoint was total major adverse cardiac events at 12-month follow-up. Secondary endpoints included target lesion revascularization at 12-month follow-up and the duration of dual antiplatelet therapy.

Results: Among 356 patients (mean age 67.4 ± 12.1 years), 77.2% were male and 39.3% were treated for myocardial infarction (MI). A total of 546 Titan2(®) stents were implanted in 420 lesions. Angiographic and clinical procedural success was achieved in all cases. No cases of in-hospital major adverse cardiac events or acute stent thrombosis were reported. Of 335 patients (94.1%) with 12-month clinical follow-up, four (1.2%) died, MI occurred in five (1.5%), target lesion revascularization was performed in 17 (5.1%) and major adverse cardiac events occurred in 24 (7.2%). One patient (0.3%) suffered late stent thrombosis during follow-up, but no cases of acute or subacute stent thrombosis occurred. Dual antiplatelet therapy continued beyond 6 months in 64.5% of patients.

Conclusions: In real-world practice, Titan2(®) stent implantation achieves an excellent immediate outcome, with a low incidence of major adverse cardiac events at 12-month follow-up.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Coated Materials, Biocompatible*
  • Coronary Angiography
  • Coronary Stenosis / complications
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / mortality
  • Coronary Stenosis / therapy*
  • Drug Therapy, Combination
  • Female
  • France
  • Government Agencies
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / diagnostic imaging
  • Myocardial Infarction / etiology
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy*
  • Platelet Aggregation Inhibitors / therapeutic use
  • Prospective Studies
  • Prosthesis Design
  • Registries
  • Severity of Illness Index
  • Stents*
  • Thrombosis / etiology
  • Time Factors
  • Titanium*
  • Treatment Outcome

Substances

  • Coated Materials, Biocompatible
  • Platelet Aggregation Inhibitors
  • titanium nitride
  • Titanium