Early and mid-term clinical outcomes with the CATANIA coronary stent system vs. bare metal stents in patients with coronary artery disease

Cardiovasc Revasc Med. 2009 Oct-Dec;10(4):216-20. doi: 10.1016/j.carrev.2009.07.001.

Abstract

Background: The potential for the CATANIA (CAT) stent to be an alternative to both bare-metal stents (BMS) and drug-eluting stents (DES) has been recently demonstrated in the Assessment of The LAtest Non-Thrombogenic Angioplasty stent (ATLANTA) first-in-human study. The aim of the present study was to compare short-term outcomes of patients treated with the CAT stent with those treated with BMS.

Methods: Based on an internal registry, the 30-day and 6-month risk-adjusted outcomes for patients who received the CAT stent (n=254) were compared against outcomes of a historical cohort of patients who received BMS (n=552) between January 2001 and December 2001.

Results: At 30 days, use of BMS vs. the CAT stent resulted in borderline significant differences with respect to major adverse cardiac and cerebrovascular events (MACCE) and cardiac death or myocardial infarction. At 6 months, BMS showed a statistically significant higher adjusted risk of MACCE (HR 2.79, 95% CIs 1.20-6.48, P=.017) and no differences with respect to the subcomponent end points. The cumulative incidence of definite stent thrombosis (Academic Research Consortium defined) at 6 months was 0.39% for the CAT stent and 2.35% for the BMS.

Conclusions: This study confirms the favorable early and mid-term safety profile and the high-level efficacy of the CAT stent in the treatment of de novo coronary lesions seen in the ATLANTA trial. The use of stents with a nanothin Polyzene-F surface treatment provided improved results with respect to BMS and lower risk of acute and subacute stent thrombosis.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Cerebrovascular Disorders / etiology
  • Cerebrovascular Disorders / mortality
  • Coated Materials, Biocompatible*
  • Cohort Studies
  • Coronary Angiography
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Metals*
  • Middle Aged
  • Myocardial Infarction / etiology
  • Myocardial Infarction / mortality
  • Proportional Hazards Models
  • Prosthesis Design
  • Registries
  • Risk Assessment
  • Risk Factors
  • Stents*
  • Thrombosis / etiology
  • Time Factors
  • Treatment Outcome

Substances

  • Coated Materials, Biocompatible
  • Metals