Drug-coated versus bare-metal stents for elderly patients: A predefined sub-study of the LEADERS FREE trial

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Published on: September 18, 2015

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Marie-Claude Morice1, Suneel Talwar2, Oliver Gaemperli3

  • 1Ramsay Générale de Santé - ICPS, Massy, France.

International Journal of Cardiology
|June 6, 2017
PubMed

Insights

Polymer-free drug-eluting stents (DCS) demonstrated superior safety and efficacy compared to bare metal stents (BMS) in elderly patients, even with only one month of dual antiplatelet therapy (DAPT). This finding supports DCS use in this high-risk population.

Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Geriatric Medicine

Background:

  • The LEADERS FREE trial previously established the safety and efficacy of polymer-free drug-eluting stents (DCS) over bare metal stents (BMS) in high-bleeding risk patients on short-term dual antiplatelet therapy (DAPT).
  • This analysis focuses on a pre-specified subgroup of elderly patients (aged ≥75 years) from the LEADERS FREE trial to evaluate outcomes in this specific demographic.

Purpose of the Study:

  • To report the characteristics and clinical outcomes of elderly patients (≥75 years) treated with polymer-free DCS versus BMS in the LEADERS FREE trial.
  • To assess the safety and efficacy of a one-month DAPT regimen in this elderly, high-bleeding risk population.

Main Methods:

  • Elderly patients (≥75 years) were included if they met trial criteria, such as the need for oral anticoagulants, recent bleeding, anemia, chronic renal failure, or cancer.
  • All participants received a one-month course of DAPT.
  • Primary endpoints included efficacy (clinically driven target lesion revascularization - TLR) and safety (composite of cardiac death, myocardial infarction, and stent thrombosis), with bleeding events also recorded up to 390 days.

Main Results:

  • 1564 elderly patients (63.4% of the total population) were enrolled, with an average of two inclusion criteria per patient.
  • DCS demonstrated significantly lower rates for both the primary safety endpoint (10.7% vs. 14.3%, p=0.03) and the primary efficacy endpoint (5.8% vs. 10.8%, p=0.0003) compared to BMS.
  • Major bleeding rates were high but similar between DCS and BMS groups (7.3% vs. 8.2%, p=0.55). Elderly patients with age as the sole entry criterion showed favorable outcomes, with lower major bleeding rates.

Conclusions:

  • In elderly patients within the LEADERS FREE trial, polymer-free DCS combined with a one-month DAPT regimen offered significant advantages in safety and efficacy compared to BMS.
  • The findings support the use of polymer-free DCS in elderly patients at high bleeding risk, even with a limited DAPT duration.
Abstract

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