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Clinical Research in Cardiology

, Volume 108, Issue 1, pp 31–38 | Cite as

Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial

  • Gert RichardtEmail author
  • Luc Maillard
  • Marco Stefano Nazzaro
  • Mohamed Abdel-Wahab
  • Didier Carrié
  • Andres Iñiguez
  • Philippe Garot
  • Mohammed Abdellaoui
  • Marie-Claude Morice
  • David Foley
  • Samuel Copt
  • Hans-Peter Stoll
  • Philip Urban
Original Paper
  • 171 Downloads

Abstract

Objective

Diabetics are at increased risk after stent implantation and potentially sensitive to the type of stent and dual anti-platelet therapy (DAPT). The randomized, double-blind LEADERS FREE trial compared 2432 patients at high bleeding risk (HBR) receiving either a polymer-free BA9-coated stent (DCS) or a bare metal stent (BMS) with 1 month of DAPT, and showed superior safety and efficacy of the DCS at 2 years. We report outcomes at 2 years of the pre-specified diabetic subgroup.

Methods and results

The diabetic sub-group comprised 805 (33.1%) patients; 262 (10.8%) were insulin-dependent (IDDM). Compared to non-diabetics, diabetics were younger and had more risk factors and multi-vessel disease. They suffered higher rates of death (15.6 vs. 12.2%, p = 0.01), cardiac death (8.3 vs. 5.9%, p = 0.02), myocardial infarction (MI) (11.1 vs. 7.8%, p = 0.009) and definite/probable stent thrombosis (3.1 vs. 1.7%, p = 0.01), but rates of clinically-indicated TLR (9.1 vs. 9.5%, p = 0.93) and BARC 3–5 bleeding (10.2 vs. 8.4%, p = 0.20) were comparable. Compared to diabetic patients treated with a BMS, diabetic DCS recipients required less clinically driven TLR (6.3 vs. 12.2%, p = 0.006). The primary safety endpoint (cardiac death, MI, definite/probable stent thrombosis) occurred numerically less frequently in the DCS group (14.9 vs. 19.7%, p = 0.10), and was significantly lower in IDDM patients (13.8 vs. 25.4%, p = 0.03). BARC 3–5 was similar for patients treated with DCS (9.9%) and BMS (10.5%, p = 0.84).

Conclusions

In diabetic HBR patients, DCS significantly reduced re-intervention rates over BMS, and showed a strong trend towards a safety benefit at 2 years.

Clinical trial registration

ClinicalTrials.gov number: NCT01623180.

Keywords:

Diabetes mellitus Bleeding Drug-coated stents 

Notes

Compliance with ethical standards

Conflict of interest

M.-C. Morice is the chief executive officer and a shareholder of the Cardiovascular European Research Center (CERC). S. Copt and H.-P. Stoll are full-time employees of the sponsor company (Biosensors). P. Urban is a consultant to Biosensors and has received honoraria from Terumo, Sinomed, Astra-Zeneca, and Edwards Lifesciences during the past 12 months. All other authors have no conflict of interest to disclose.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Gert Richardt
    • 1
    Email author
  • Luc Maillard
    • 2
  • Marco Stefano Nazzaro
    • 3
  • Mohamed Abdel-Wahab
    • 1
  • Didier Carrié
    • 4
  • Andres Iñiguez
    • 5
  • Philippe Garot
    • 6
  • Mohammed Abdellaoui
    • 7
  • Marie-Claude Morice
    • 8
  • David Foley
    • 9
  • Samuel Copt
    • 10
  • Hans-Peter Stoll
    • 10
  • Philip Urban
    • 11
  1. 1.Heart Center, Segeberger Kliniken GmbHBad SegebergGermany
  2. 2.Clinique AxiumAix-en-ProvenceFrance
  3. 3.Azienda Ospedaliera San Camillo ForlaniniRomeItaly
  4. 4.CHU Toulouse RangueilToulouseFrance
  5. 5.University Hospital VigoVigoSpain
  6. 6.Hôpital Privé Claude Galien ICPSQuincy-Sous-SenartFrance
  7. 7.Groupe Hospitalier Mutualiste de Grenoble (GHM)GrenobleFrance
  8. 8.Cardiovascular European Research Center CERCMassyFrance
  9. 9.Beaumont HospitalDublinIreland
  10. 10.Biosensors Clinical ResearchMorgesSwitzerland
  11. 11.Hopital LaTourGenevaSwitzerland

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