Frequency of Stent Thrombosis Risk at 5 Years in Women Versus Men With Zotarolimus-Eluting Compared With Sirolimus-Eluting Stent

Am J Cardiol. 2016 Oct 15;118(8):1178-1186. doi: 10.1016/j.amjcard.2016.07.032. Epub 2016 Jul 29.

Abstract

The prevalence of factors that are associated with an increased risk of stent thrombosis (ST), including smoking, diabetes mellitus, and small stent size, is different in women and men who underwent percutaneous coronary intervention. Thus, gender may potentially modify the relation between stent type and the incidence of ST during long-term follow-up. We explored the data of Patient Related Outcomes With Endeavor Versus Cypher stenting Trial (PROTECT) to evaluate this hypothesis. PROTECT randomized 2,061 women and 6,648 men who underwent percutaneous coronary intervention for various indications to Endeavor zotarolimus-eluting stenting (E-ZES) or Cypher sirolimus-eluting stenting (C-SES). Dual antiplatelet therapy was prescribed for at least 3 months. Data on study end points were collected until 5 years after randomization, including ST, death, and cardiovascular events. We analyzed end points and treatment effect (E-ZES vs C-SES) in relation to gender. Women were on average 4.7 years older (65.8 vs 61.1), had a higher prevalence of insulin-dependent diabetes mellitus, were less often smokers, and had a shorter total stent length than men. At discharge and throughout follow-up, a slightly lower fraction of women were using dual antiplatelet therapy. During 5-year follow-up, definite or probable ST was observed in 36 women (1.8%) and 152 men (2.4%; log-rank p = 0.15). E-ZES reduced the incidence of ST compared with C-SES in women (hazard ratio 0.58) and men (hazard ratio 0.61), with no evidence of heterogeneity (p = 0.89). In conclusion, in PROTECT, women and men had similar cumulative incidence of ST at 5 years after stent placement. The favorable effect of the study stent E-ZES over C-SES was not modified by gender.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antibiotics, Antineoplastic / therapeutic use*
  • Coronary Artery Disease / therapy*
  • Diabetes Mellitus / drug therapy
  • Diabetes Mellitus / epidemiology
  • Drug-Eluting Stents*
  • Female
  • Graft Occlusion, Vascular / epidemiology*
  • Humans
  • Hypoglycemic Agents / therapeutic use
  • Insulin / therapeutic use
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Proportional Hazards Models
  • Sex Factors
  • Sirolimus / analogs & derivatives*
  • Sirolimus / therapeutic use*
  • Thrombosis / epidemiology*
  • Treatment Outcome

Substances

  • Antibiotics, Antineoplastic
  • Hypoglycemic Agents
  • Insulin
  • Platelet Aggregation Inhibitors
  • zotarolimus
  • Sirolimus