title: Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients.
abstract: BACKGROUND
  Diabetes mellitus and angiographic coronary artery disease complexity are intertwined and unfavorably affect prognosis after percutaneous coronary interventions, but their relative impact on long-term outcomes after percutaneous coronary intervention with drug-eluting stents remains controversial. This study determined drug-eluting stents outcomes in relation to diabetic status and coronary artery disease complexity as assessed by the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score.
  
  
  RESULTS
  In a patient-level pooled analysis from 4 all-comers trials, 6081 patients were stratified according to diabetic status and according to the median SYNTAX score ≤11 or >11. The primary end point was major adverse cardiac events, a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization within 2 years. Diabetes mellitus was present in 1310 patients (22%), and new-generation drug-eluting stents were used in 4554 patients (75%). Major adverse cardiac events occurred in 173 diabetics (14.5%) and 436 nondiabetic patients (9.9%; P<0.001). In adjusted Cox regression analyses, SYNTAX score and diabetes mellitus were both associated with the primary end point (P<0.001 and P=0.028, respectively; P for interaction, 0.07). In multivariable analyses, diabetic versus nondiabetic patients had higher risks of major adverse cardiac events (hazard ratio, 1.25; 95% confidence interval, 1.03-1.53; P=0.026) and target lesion revascularization (hazard ratio, 1.54; 95% confidence interval, 1.18-2.01; P=0.002) but similar risks of cardiac death (hazard ratio, 1.41; 95% confidence interval, 0.96-2.07; P=0.08) and myocardial infarction (hazard ratio, 0.89; 95% confidence interval, 0.64-1.22; P=0.45), without significant interaction with SYNTAX score ≤11 or >11 for any of the end points.
  
  
  CONCLUSIONS
  In this population treated with predominantly new-generation drug-eluting stents, diabetic patients were at increased risk for repeat target-lesion revascularization consistently across the spectrum of disease complexity. The SYNTAX score was an independent predictor of 2-year outcomes but did not modify the respective effect of diabetes mellitus.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00297661, NCT00389220, NCT00617084, and NCT01443104.
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Konstantinos C
authors.initials: KC
authors.lastname: Koskinas
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: George C M
authors.initials: GC
authors.lastname: Siontis
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Raffaele
authors.initials: R
authors.lastname: Piccolo
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Anna
authors.initials: A
authors.lastname: Franzone
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Alan
authors.initials: A
authors.lastname: Haynes
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Julie
authors.initials: J
authors.lastname: Rat-Wirtzler
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Lorenz
authors.initials: L
authors.lastname: Räber
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Dik
authors.initials: D
authors.lastname: Heg
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.affiliation: From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.). stephan.windecker@insel.ch.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000150:complications* / Q000401:mortality / Q000628:therapy*; D048909:Diabetes Complications / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation
keywords: coronary artery disease; diabetes mellitus; drug-eluting stents; outcome studies; percutaneous coronary intervention