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

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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.

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Authors and Affiliations

  1. Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany

    Gert Richardt & Mohamed Abdel-Wahab

  2. Clinique Axium, Aix-en-Provence, France

    Luc Maillard

  3. Azienda Ospedaliera San Camillo Forlanini, Rome, Italy

    Marco Stefano Nazzaro

  4. CHU Toulouse Rangueil, Toulouse, France

    Didier Carrié

  5. University Hospital Vigo, Vigo, Spain

    Andres Iñiguez

  6. Hôpital Privé Claude Galien ICPS, Quincy-Sous-Senart, France

    Philippe Garot

  7. Groupe Hospitalier Mutualiste de Grenoble (GHM), Grenoble, France

    Mohammed Abdellaoui

  8. Cardiovascular European Research Center CERC, Massy, France

    Marie-Claude Morice

  9. Beaumont Hospital, Dublin, Ireland

    David Foley

  10. Biosensors Clinical Research, Morges, Switzerland

    Samuel Copt & Hans-Peter Stoll

  11. Hopital LaTour, Geneva, Switzerland

    Philip Urban

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  1. Gert Richardt
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  2. Luc Maillard
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  9. Marie-Claude Morice
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Corresponding author

Correspondence to Gert Richardt.

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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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Richardt, G., Maillard, L., Nazzaro, M.S. et al. Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial. Clin Res Cardiol 108, 31–38 (2019). https://doi.org/10.1007/s00392-018-1308-1

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  • DOI: https://doi.org/10.1007/s00392-018-1308-1

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