Long-term clinical outcomes after drug eluting stent implantation in women with de novo coronary lesions. Results from the REAL (REgistro Regionale AngiopLastiche Emilia-Romagna) multicenter registry

Int J Cardiol. 2011 May 19;149(1):55-62. doi: 10.1016/j.ijcard.2009.11.044. Epub 2010 Jan 8.

Abstract

Background: The long-term effectiveness of drug eluting stents (DESs) in a real-world setting of female patients is currently unclear.

Methods and results: We analyzed long-term follow-up (up to 3 years) data from all female patients with de novo lesions enrolled in a prospective web-based multicenter registry (REAL Registry; study period, July 2002-June 2006) including all 15 hospitals performing PCI in the Emilia-Romagna region of Italy. Among the 3549 women without ST elevation myocardial infarction, 2434 were treated with BMSs alone and 1115 with DESs alone. At 3 years, use of DESs was associated with a lower propensity score adjusted incidence of MACE [cardiac mortality, non-fatal myocardial infarction and target vessel revascularization (TVR); 19.5% vs. 24.4%; HR 0.75, p=0.006)] and TVR (11.6% vs. 15.6%; HR 0.68, p=0.004) compared with BMSs. No difference was apparent in terms of adjusted 3-year cardiac mortality or myocardial infarction. Nevertheless, after the first 6 months of follow-up, a non significantly increased risk of myocardial infarction and stent thrombosis was found in the DES group.

Conclusions: In this real-world female registry, the use of DESs was associated with a 3-year reduction of TVR and MACE in comparison with the use of BMSs. However, the observed (non-significant) increment of late AMI makes performing larger studies to clarify the long-term safety of DESs mandatory.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary / mortality*
  • Coronary Restenosis / mortality
  • Drug-Eluting Stents / adverse effects
  • Drug-Eluting Stents / statistics & numerical data*
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Italy / epidemiology
  • Middle Aged
  • Myocardial Infarction / mortality*
  • Myocardial Infarction / therapy*
  • Proportional Hazards Models
  • Registries / statistics & numerical data*
  • Risk Factors
  • Treatment Outcome