Dual Antiplatelet Therapy for 6 Months vs 12 Months After New-generation Drug-eluting Stent Implantation: Matched Analysis of ESTROFA-DAPT and ESTROFA-2

Rev Esp Cardiol (Engl Ed). 2015 Oct;68(10):838-45. doi: 10.1016/j.rec.2015.01.008. Epub 2015 Jun 11.

Abstract

Introduction and objectives: The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings.

Methods: A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months.

Results: The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) CONCLUSIONS: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen.

Keywords: Antiplatelet therapy; Coronary artery disease; Drug-eluting stents; Enfermedad coronaria; Stents farmacoactivos; Tratamiento antiagregante plaquetario.

Publication types

  • Clinical Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome / diagnosis
  • Acute Coronary Syndrome / surgery*
  • Aged
  • Coronary Angiography
  • Coronary Restenosis / diagnosis
  • Coronary Restenosis / epidemiology
  • Coronary Restenosis / prevention & control*
  • Disease-Free Survival
  • Drug-Eluting Stents*
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Percutaneous Coronary Intervention*
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Prognosis
  • Prospective Studies
  • Registries*
  • Spain / epidemiology
  • Time Factors

Substances

  • Platelet Aggregation Inhibitors