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Second-generation versus first-generation drug-eluting stents in patients with and without diabetes mellitus: pooled analysis from the RESET and NEXT trials

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Abstract

The impact of second-generation drug-eluting stent (G2-DES) implantations compared with first-generation drug-eluting stents (G1-DES) implantations on long-term clinical outcomes after percutaneous coronary intervention in patients with and without diabetes mellitus (DM) has not yet been adequately assessed. This pooled analysis compared 3-year clinical outcomes between G1- and G2-DES according to the presence or absence of DM, using individual patient-level data from the RESET and NEXT trials. Among 6431 patients, G1-DES and G2-DES were used in 713 and 2211 patients, respectively, in the DM stratum, and 887 and 2620 patients, respectively, in the non-DM stratum. Cumulative incidence of and adjusted hazard ratio (HR) for target-lesion revascularization (TLR) were not significantly different between G2- and G1-DES in both strata [DM, 8.7 versus 10.1%, adjusted HR: 0.80, 95% confidence interval (CI) 0.59–1.10, P = 0.17; non-DM, 5.7 versus 6.2%, adjusted HR: 0.86, 95% CI 0.62–1.22, P = 0.38]. In the insulin-treated DM (ITDM), G2-DES had a significantly lower adjusted HR for TLR compared with G1-DES, although there was no significant difference in the non-ITDM (ITDM, adjusted HR: 0.54, 95% CI 0.32–0.96, P = 0.04; non-ITDM, adjusted HR: 0.95, 95% CI 0.66–1.42, P = 0.81). G2-DES provided similar risk for TLR in non-ITDM and non-DM patients compared with G1-DES. However, G2-DES compared with G1-DES had a lower risk for TLR among ITDM patients.

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Acknowledgements

We appreciate the effort of the members of the cardiac catheterization laboratory and clinical research coordinators in the participating centers. A list of all RESET and NEXT Investigators is given in the Appendix in the Data Supplement (Supplemental Appendix A and B).

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Authors and Affiliations

  1. Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, 606-8507, Japan

    Kenji Nakatsuma, Hiroki Shiomi & Takeshi Kimura

  2. Division of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan

    Masahiro Natsuaki

  3. Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan

    Takeshi Morimoto

  4. Division of Cardiology, Japan Community Health CARE Organization Hokkaido Hospital, Sapporo, Japan

    Keiichi Igarashi

  5. Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan

    Kazushige Kadota

  6. Division of Cardiology, Tokyo General Hospital, Tokyo, Japan

    Toshiya Muramatsu

  7. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan

    Kengo Tanabe

  8. Department of Cardiovascular Medicine, Iwate Medical University, Morioka, Japan

    Yoshihiro Morino

  9. Department of Cardiovascular Medicine, Wakayama Medical University Hospital, Wakayama, Japan

    Takashi Akasaka

  10. Division of Cardiology, Tenri Hospital, Tenri, Japan

    Yoshihisa Nakagawa

  11. Division of Cardiology, Teikyo University Hospital, Tokyo, Japan

    Ken Kozuma

Authors
  1. Kenji Nakatsuma
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  2. Hiroki Shiomi
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  3. Masahiro Natsuaki
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  4. Takeshi Morimoto
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  6. Kazushige Kadota
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  7. Toshiya Muramatsu
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  8. Kengo Tanabe
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  11. Yoshihisa Nakagawa
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  12. Ken Kozuma
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  13. Takeshi Kimura
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On behalf of the RESET and NEXT investigators

Corresponding author

Correspondence to Takeshi Kimura.

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Sources of funding

The Abbott Vascular Japan (Tokyo, Japan) and Terumo (Tokyo, Japan).

Conflict of interest

Dr. Kozuma and Dr. Tanabe have served on the advisory boards of Abbott Vascular and Terumo; and have received lecture fees from Abbott Vascular and Terumo. Dr. Kadota has received honoraria from Abbott Vascular and Terumo; and has served on the advisory boards of Abbott Vascular. Dr. Morino has served on the advisory board of Abbott Vascular and Terumo. Dr. T. Kimura has served on the advisory board of Terumo and Abbott Vascular. The other authors report no conflicts.

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Nakatsuma, K., Shiomi, H., Natsuaki, M. et al. Second-generation versus first-generation drug-eluting stents in patients with and without diabetes mellitus: pooled analysis from the RESET and NEXT trials. Cardiovasc Interv and Ther 33, 125–134 (2018). https://doi.org/10.1007/s12928-017-0458-9

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  • DOI: https://doi.org/10.1007/s12928-017-0458-9

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