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Cardiovascular Intervention and Therapeutics

, Volume 33, Issue 2, pp 125–134 | Cite as

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

  • Kenji Nakatsuma
  • Hiroki Shiomi
  • Masahiro Natsuaki
  • Takeshi Morimoto
  • Keiichi Igarashi
  • Kazushige Kadota
  • Toshiya Muramatsu
  • Kengo Tanabe
  • Yoshihiro Morino
  • Takashi Akasaka
  • Yoshihisa Nakagawa
  • Ken Kozuma
  • Takeshi Kimura
  • On behalf of the RESET and NEXT investigators
Original Article

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.

Keywords

Diabetes mellitus Angioplasty Drug-eluting stents 

Notes

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).

Compliance with ethical standards

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.

Supplementary material

12928_2017_458_MOESM1_ESM.docx (805 kb)
Supplementary material 1 (DOCX 804 kb)

References

  1. 1.
    Schofer J, Schlüter M, Rau T, Hammer F, Haag N, Mathey DG. Influence of treatment modality on angiographic outcome after coronary stenting in diabetic patients: a controlled study. J Am Coll Cardiol. 2000;35:1554–9.CrossRefPubMedGoogle Scholar
  2. 2.
    West NEJ. Clinical and angiographic predictors of restenosis after stent deployment in diabetic patients. Circulation. 2004;109:867–73.CrossRefPubMedGoogle Scholar
  3. 3.
    Qin S, Zhou Y, Jiang H, Hu B, Tao L, Xie M. The association of diabetes mellitus with clinical outcomes after coronary stenting: a meta-analysis. PLoS One. 2013;8:e72710.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Machecourt J, Danchin N, Lablanche JM, Fauvel JM, Bonnet JL, Marliere S, et al. Risk factors for stent thrombosis after implantation of sirolimus-eluting stents in diabetic and nondiabetic patients. J Am Coll Cardiol. 2007;50:501–8.CrossRefPubMedGoogle Scholar
  5. 5.
    Akin I, Bufe A, Eckardt L, Reinecke H, Senges J, Richardt G, et al. Comparison of outcomes in patients with insulin-dependent versus non-insulin dependent diabetes mellitus receiving drug-eluting stents (from the first phase of the prospective Multicenter German DES.DE Registry). Am J Cardiol. 2010;106:1201–7.CrossRefPubMedGoogle Scholar
  6. 6.
    Tada T, Kimura T, Morimoto T, Ono K, Furukawa Y, Nakagawa Y, et al. Comparison of three-year clinical outcomes after sirolimus-eluting stent implantation among insulin-treated diabetic, non–insulin-treated diabetic, and non-diabetic patients from J-Cypher registry. Am J Cardiol. 2011;107:1155–62.CrossRefPubMedGoogle Scholar
  7. 7.
    Hillegass WB, Patel MR, Klein LW, Gurm HS, Brennan JM, Anstrom KJ, et al. Long-term outcomes of older diabetic patients after percutaneous coronary stenting in the US: a report from the national cardiovascular data registry, 2004–2008. J Am Coll Cardiol. 2012;60:2280–9.CrossRefPubMedGoogle Scholar
  8. 8.
    Moussa I. Impact of sirolimus-eluting stents on outcome in diabetic patients: a SIRIUS (SIRolImUS-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) substudy. Circulation. 2004;109:2273–8.CrossRefPubMedGoogle Scholar
  9. 9.
    Stettler C, Allemann S, Wandel S, Kastrati A, Morice MC, Schomig A, et al. Drug eluting and bare metal stents in people with and without diabetes: collaborative network meta-analysis. BMJ. 2008;337:a1331.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Bangalore S, Kumar S, Fusaro M, Amoroso N, Kirtane AJ, Byrne RA, et al. Outcomes with various drug eluting or bare metal stents in patients with diabetes mellitus: mixed treatment comparison analysis of 22,844 patient years of follow-up from randomised trials. BMJ. 2012;345:e5170.CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Kimura T, Morimoto T, Natsuaki M, Shiomi H, Igarashi K, Kadota K, et al. Comparison of everolimus-eluting and sirolimus-eluting coronary stents: 1-year outcomes from the randomized evaluation of sirolimus-eluting versus everolimus-eluting stent trial (RESET). Circulation. 2012;126:1225–36.CrossRefPubMedGoogle Scholar
  12. 12.
    Shiomi H, Kozuma K, Morimoto T, Igarashi K, Kadota K, Tanabe K, et al. Long-term clinical outcomes after everolimus- and sirolimus-eluting coronary stent implantation: final 3-year follow-up of the randomized evaluation of sirolimus-eluting versus everolimus-eluting stent trial. Circ Cardiovasc Interv. 2014;7:343–54.CrossRefPubMedGoogle Scholar
  13. 13.
    Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, et al. Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent. J Am Coll Cardiol. 2013;62:181–90.CrossRefPubMedGoogle Scholar
  14. 14.
    Natsuaki M, Kozuma K, Morimoto T, Shiomi H, Kimura T. Two-year outcome of a randomized trial comparing second-generation drug-eluting stents using biodegradable or durable polymer. JAMA. 2014;311:2125.CrossRefPubMedGoogle Scholar
  15. 15.
    Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, et al. Final 3-year outcome of a randomized trial comparing second-generation drug-eluting stents using either biodegradable polymer or durable polymer. Circ Cardiovasc Interv. 2015;8:e002817.CrossRefPubMedGoogle Scholar
  16. 16.
    Mauri L, Hsieh W, Massaro JM, Ho KKL, D’Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007;356:1020–9.CrossRefPubMedGoogle Scholar
  17. 17.
    Kim W-J, Lee S-W, Park S-W, Kim Y-H, Yun S-C, Lee J-Y, et al. Randomized comparison of everolimus-eluting stent versus sirolimus-eluting stent implantation for de novo coronary artery disease in patients with diabetes mellitus (ESSENCE-DIABETES): results from the ESSENCE-DIABETES trial. Circulation. 2011;124:886–92.CrossRefPubMedGoogle Scholar
  18. 18.
    Jensen LO, Thayssen P, Junker A, Maeng M, Tilsted H-H, Kaltoft A, et al. Comparison of outcomes in patients with versus without diabetes mellitus after revascularization with everolimus- and sirolimus-eluting stents (from the SORT OUT IV trial). Am J Cardiol. 2012;110:1585–91.CrossRefPubMedGoogle Scholar
  19. 19.
    Christiansen EH, Jensen LO, Thayssen P, Tilsted H-H, Krusell LR, Hansen KN, et al. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial. Lancet. 2013;381:661–9.CrossRefPubMedGoogle Scholar
  20. 20.
    Kang S, Park KH, Ahn H, Park KW, Hong YJ, Koo B, et al. Everolimus-eluting versus sirolimus-eluting coronary stents in patients with and without diabetes mellitus. Eurointervention. 2014;10:74–82.CrossRefPubMedGoogle Scholar
  21. 21.
    Johnstone MT, Creager SJ, Scales KM, Cusco JA, Lee BK, Creager MA. Impaired endothelium-dependent vasodilation in patients with insulin- dependent diabetes mellitus. Circulation. 1993;88:2510–6.CrossRefPubMedGoogle Scholar
  22. 22.
    Hartge MM, Unger T, Kintscher U. The endothelium and vascular inflammation in diabetes. Diabetes Vasc Dis Res. 2007;4:84.CrossRefGoogle Scholar

Copyright information

© Japanese Association of Cardiovascular Intervention and Therapeutics 2017

Authors and Affiliations

  • Kenji Nakatsuma
    • 1
  • Hiroki Shiomi
    • 1
  • Masahiro Natsuaki
    • 2
  • Takeshi Morimoto
    • 3
  • Keiichi Igarashi
    • 4
  • Kazushige Kadota
    • 5
  • Toshiya Muramatsu
    • 6
  • Kengo Tanabe
    • 7
  • Yoshihiro Morino
    • 8
  • Takashi Akasaka
    • 9
  • Yoshihisa Nakagawa
    • 10
  • Ken Kozuma
    • 11
  • Takeshi Kimura
    • 1
  • On behalf of the RESET and NEXT investigators
  1. 1.Department of Cardiovascular Medicine, Graduate School of MedicineKyoto UniversityKyotoJapan
  2. 2.Division of CardiologySaiseikai Fukuoka General HospitalFukuokaJapan
  3. 3.Department of Clinical EpidemiologyHyogo College of MedicineNishinomiyaJapan
  4. 4.Division of CardiologyJapan Community Health CARE Organization Hokkaido HospitalSapporoJapan
  5. 5.Department of CardiologyKurashiki Central HospitalKurashikiJapan
  6. 6.Division of CardiologyTokyo General HospitalTokyoJapan
  7. 7.Division of CardiologyMitsui Memorial HospitalTokyoJapan
  8. 8.Department of Cardiovascular MedicineIwate Medical UniversityMoriokaJapan
  9. 9.Department of Cardiovascular MedicineWakayama Medical University HospitalWakayamaJapan
  10. 10.Division of CardiologyTenri HospitalTenriJapan
  11. 11.Division of CardiologyTeikyo University HospitalTokyoJapan

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