Comparison of long-term clinical outcomes after the second-generation cobalt-chromium sirolimus-eluting stents implantation in diabetic versus non-diabetic patients: a subgroup analysis from the prospective FOCUS registry

Ann Med. 2016;48(3):202-10. doi: 10.3109/07853890.2016.1162324. Epub 2016 Mar 16.

Abstract

Background: Diabetes mellitus (DM) was broadly acknowledged as a risk factor for adverse events after coronary stent implantation. However, the role of DM in patients treated with second-generation cobalt-chromium sirolimus-eluting stents (CoCr-SES) was less known.

Methods: A total of 4720 patients available for 3-year follow-up in the prospective FOCUS registry were subdivided into the DM group and the non-DM group to assess the effect of DM on the clinical outcomes after CoCr-SES implantation both before and after propensity score matching.

Results: The rates of major adverse cardiovascular event was low (<10%) in both DM and non-DM groups but significantly greater in the DM group after matching (9.6% versus 6.1%; p = 0.005). Although the soft endpoints including target vessel revascularization (2.3% versus 2.3%; p = 0.938) and target lesion revascularization (1.2% versus 1.1%; p = 0.828) was not significantly different between two groups, the hard endpoints represented by cardiovascular death or myocardial infarction (7.3% versus 5.3%; p = 0.012) demonstrated a significant increase in the DM group.

Conclusions: This subgroup analysis demonstrated that DM significantly increased the risk of adverse events after implantation of CoCr-SES, but the general safety and efficacy performance of CoCr-SES in both diabetic and non-diabetic patients was satisfying and comparable with other types of new-generation drug-eluting stents.

Keywords: Cobalt–chromium stent; coronary artery disease; diabetes mellitus; sirolimus-eluting stent.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Chromium / adverse effects
  • Chromium / therapeutic use
  • Cobalt / adverse effects
  • Cobalt / therapeutic use
  • Coronary Artery Disease / epidemiology
  • Coronary Artery Disease / surgery*
  • Diabetes Mellitus / epidemiology*
  • Drug-Eluting Stents / adverse effects*
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Middle Aged
  • Myocardial Infarction / epidemiology
  • Percutaneous Coronary Intervention / instrumentation*
  • Prospective Studies
  • Sirolimus / adverse effects
  • Sirolimus / therapeutic use
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Chromium
  • Cobalt
  • Sirolimus