title: One year clinical outcomes in patients with insulin-treated diabetes mellitus and non-insulin-treated diabetes mellitus compared to non-diabetics after deployment of the bio-engineered COMBO stent.
abstract: BACKGROUND
  The COMBO stent is a novel sirolimus-eluting stent with a luminal anti-CD34+ antibody layer to promote vessel healing. No data is currently available on clinical outcomes after treatment with this novel bio-engineered device in diabetic patients. We evaluate clinical outcomes at twelve months after COMBO stent placement in patients without diabetes mellitus (non-DM), patients with non-insulin-treated diabetes mellitus (nITDM) and patients with insulin-treated diabetes mellitus (ITDM).
  
  
  METHODS
  This study is a pre-specified subgroup analysis of the 1000 patient all-comers REMEDEE Registry. The primary endpoint is target lesion failure (TLF), which is a combined endpoint consisting of cardiac death, target vessel-myocardial infarction (tv-MI) and target lesion revascularization (TLR) at twelve months follow-up. Kaplan Meier method is used with log rank to compare outcomes between groups.
  
  
  RESULTS
  This subgroup analysis includes 807 non-DM, 117 nITDM and 67 ITDM. Kaplan-Meier estimates for TLF at twelve months are 4.4% in non-DM, 6.8% in nITDM and 20.3% in ITDM, p<0.001 (non-DM vs nITDM p=0.244, non-DM vs ITDM p<0.001).
  
  
  CONCLUSIONS
  This study gives the first insight into the impact of insulin-treated diabetes mellitus on clinical outcome of patients treated with the novel COMBO stent. At one year after COMBO stent placement significantly higher rates of target lesion failure are seen in patients with ITDM compared to patients with nITDM and patients without DM.
authors: Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: d.n.kalkman@amc.uva.nl.
authors: Deborah N
authors: DN
authors: Kalkman
authors: Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: p.woudstra@amc.uva.nl.
authors: Pier
authors: P
authors: Woudstra
authors: Amphia Hospital Breda, Breda, The Netherlands. Electronic address: pdheyer@amphia.nl.
authors: Peter
authors: P
authors: den Heijer
authors: Craigavon Cardiac Centre, Craigavon, United Kingdom. Electronic address: ian.menown@southerntrust.hscni.net.
authors: Ian B A
authors: IB
authors: Menown
authors: Pauls Stradins Clinical University Hospital, Riga, Latvia. Electronic address: a.a.erglis@stradini.lv.
authors: Andrejs
authors: A
authors: Erglis
authors: Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: h.suryapranata@cardio.umcn.nl.
authors: Harry
authors: H
authors: Suryapranata
authors: Tergooi Ziekenhuis, Blaricum, The Netherlands. Electronic address: e.arkenbout@amc.uva.nl.
authors: Karin E
authors: KE
authors: Arkenbout
authors: Hospital Álvaro Cunqueiro - Complejo Hospitalario Universitario, Vigo, Spain. Electronic address: andres.iniguez.romo@sergas.es.
authors: Andrés
authors: A
authors: Iñiguez
authors: Isala Klinieken, Zwolle, The Netherlands. Electronic address: a.w.j.vant.hof@isala.nl.
authors: Arnoud W J
authors: AW
authors: van 't Hof
authors: Institut National de Cardiochirurgie et de Cardiologie Interventionnelle, Luxembourg. Electronic address: philmul57@gmail.com.
authors: Philippe
authors: P
authors: Muller
authors: Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: tijssenj@outlook.com.
authors: Jan G
authors: JG
authors: Tijssen
authors: Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: r.j.dewinter@amc.uva.nl.
authors: Robbert J
authors: RJ
authors: de Winter
mesh_terms: D000368:Aged; D057005:Bioengineering / Q000639:trends; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000401:mortality / Q000639:trends; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome
chemical_list: D007328:Insulin
keywords: Clinical outcomes; Diabetes mellitus; Drug-eluting stent; Endothelial progenitor cell; Percutaneous coronary intervention