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Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial

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Abstract

Aims

To compare the outcomes of patients undergoing non-cardiac surgery (NCS) after PCI with either a drug-coated stent (DCS) or a bare-metal stent (BMS), followed by 1-month dual antiplatelet therapy and to explore the impact of the timing of NCS.

Methods

This is a subgroup analysis of the LEADERS FREE trial. The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR).

Results

Out of 2432 patients included in the LEADERS FREE trial, 278 (11.4%) underwent NCS within 1 year after PCI. Among NCS patients, the 1-year safety end point was numerically lower with DCS; however, this difference was not significant as compared to BMS (4.7% vs. 10.1%, HR: 0.459 [0.178–1.183], p = 0.099), clinically driven TLR was significantly lower after DCS (2.4% vs. 8.3%, HR: 0.281 [0.079—0.996], p = 0.036), and BARC 3–5 bleeding was similar with DCS vs. BMS (10.2% vs. 7.5%, p = 0.438). In patients treated with BMS, NCS within 3 months after PCI was associated with higher incidence of the safety end point than NCSs performed later: 14.9% vs. 4.4%, HR: 3.586 [1.012–12.709], p = 0.034. The timing of surgery had no impact on patients treated with DCS (4.7% vs. 4.7%, p = 0.947).

Conclusions

Among patients undergoing NCS after PCI, DCS-treated patients had a lower probability of clinically driven TLR compared with BMS. However, there was no significant difference in the occurrence of the primary composite safety end point or bleeding complications. Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.

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Acknowledgements

We would like to thank Ms. Sara Sadozai Slama for the great statistical support.

Funding

LEADERS FREE is funded by Biosensors Europe.

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Authors and Affiliations

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

    Gert Richardt, Mohammad Abdelghani, Abdelhakim Allali & Ralph Toelg

  2. Cardiology Department, Amesterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

    Mohammad Abdelghani

  3. Cardiology Department, Al-Azhar University, Cairo, Egypt

    Mohammad Abdelghani

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

    Mohamed Abdellaoui

  5. Charité Campus Virchow Klinikum, Berlin, Germany

    Florian Krackhardt

  6. Norwegian University of Science and Technology, Trondheim, Norway

    Rune Wiseth

  7. Cardiovascular European Research Center CERC, Massy, France

    Marie-Claude Morice

  8. Biosensors Clinical Research, Morges, Switzerland

    Samuel Copt & Hans-Peter Stoll

  9. Hopital LaTour, Geneva, Switzerland

    Philip Urban

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  1. Gert Richardt
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Correspondence to Abdelhakim Allali.

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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 paid consultant to Biosensors, has received honoraria from Edwards Lifesciences during the past 12 months, and is a shareholder of the Cardiovascular European Research Center (CERC). All other authors have no conflict of interest to disclose.

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Richardt, G., Abdelghani, M., Allali, A. et al. Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial. Clin Res Cardiol 110, 162–171 (2021). https://doi.org/10.1007/s00392-020-01672-3

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