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Clinical outcomes in diabetic and non-diabetic patients with drug-eluting stents: results from the first phase of the prospective multicenter German DES.DE registry

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Abstract

Background

Patients with diabetes mellitus (DM) undergoing coronary revascularization are at increased risk for adverse outcomes. Without sufficiently powered data from diabetic subgroup analyses and in absence of randomized controlled trials in diabetic patients with primary clinical outcomes controversy is ongoing over safety and efficacy of drug-eluting stents (DES) in diabetic patients.

Methods and results

Between October 2005 and October 2006, 1,659 diabetic and 3,559 non-diabetic patients treated with DES (Paclitaxel or Sirolimus-eluting stents) were enrolled at 98 Drug-Eluting-Stent.DEutschland (DES.DE) sites. Major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of death, myocardial infarction, and stroke, as well as target vessel revascularization (TVR) were defined as primary endpoints. The baseline clinical and descriptive morphology of coronary artery disease revealed more severe findings in diabetic patients. At 1-year follow-up, diabetic patients treated with DES had significantly higher rates for overall death (5.6 vs. 3.4%; p < 0.01), myocardial infarction (4.8 vs. 3.4%; p = 0.05), stroke (1.7 vs. 0.9%; p < 0.05), MACCE (10.9 vs. 7.1%; p < 0.001), and overall stent thrombosis (4.9 vs. 3.3%; p < 0.01) with slightly elevated rates for TVR (12.0 vs. 10.4%; p = 0.17); data which remained after risk-adjustment.

Conclusion

Data collected in DES.DE revealed that despite the use of DES the risk of myocardial infarction, death, and thrombotic events remains higher in diabetic patients.

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Authors and Affiliations

  1. Divisions of Cardiology, Pulmonology, Department of Internal Medicine I, Intensive Care Unit, University Hospital Rostock, Rostock School of Medicine, Ernst-Heydemann-Str. 6, 18057, Rostock, Germany

    Ibrahim Akin, Detlev Burska & Christoph A. Nienaber

  2. Department of Cardiology, Helios Clinic Wuppertal, University of Witten/Herdecke, Wuppertal, Germany

    Alexander Bufe

  3. Department of Cardiology, Heart Center Ludwigshafen, Ludwigshafen, Germany

    Steffen Schneider & Jochen Senges

  4. Department of Cardiology, University Hospital Münster, Münster, Germany

    Holger Reinecke & Lars Eckardt

  5. Department of Cardiology, Hospital Bad Segeberg, Bad Segeberg, Germany

    Gert Richardt

  6. Department of Cardiology, Asklepios Hospital Hamburg, Hamburg, Germany

    Karl-Heinz Kuck

Authors
  1. Ibrahim Akin
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  2. Alexander Bufe
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  7. Detlev Burska
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  8. Jochen Senges
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  9. Karl-Heinz Kuck
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  10. Christoph A. Nienaber
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Corresponding author

Correspondence to Christoph A. Nienaber.

Additional information

for the DES.DE Study group.

Appendix

Appendix

Organization of the German DES.DE Registry

Members of the Steering Committee: Christoph A. Nienaber (Chairman), Karl-Heinz Kuck (Chairman), Christoph Bode, Fokko de Haan, Gert Richardt, Georg Sabin, Jochen Senges, Sigmund Silber, Jürgen Stumpf, Ulrich Tebbe, Stepfan Willich, Thomas Fetsch, Gabriele Sailer, Steffen Schneider.

Members of the Clinical Event Committee: Bernhard Meier, Ahmed Khattab, Martin G Gottwik.

Internet data acquisition (Institute of Clinical Research of the German Cardiac Society): Thomas Fetsch, Petra Kremer.

Statistical analysis (Heart Center Ludwigshafen): Steffen Schneider.

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Akin, I., Bufe, A., Schneider, S. et al. Clinical outcomes in diabetic and non-diabetic patients with drug-eluting stents: results from the first phase of the prospective multicenter German DES.DE registry. Clin Res Cardiol 99, 393–400 (2010). https://doi.org/10.1007/s00392-010-0136-8

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  • DOI: https://doi.org/10.1007/s00392-010-0136-8

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