title: Differential clinical responses to everolimus-eluting and Paclitaxel-eluting coronary stents in patients with and without diabetes mellitus.
abstract: BACKGROUND
  Some (but not all) prior trials have reported differential outcomes after percutaneous coronary intervention with paclitaxel-eluting stents versus stents eluting rapamycin analogs according to the presence of diabetes mellitus. These studies lacked sufficient power to examine individual safety and efficacy end points.
  
  
  RESULTS
  To determine whether an interaction exists between the presence of diabetes mellitus and treatment with everolimus-eluting stents compared with paclitaxel-eluting stents, we pooled the databases from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SPIRIT) II, SPIRIT III, SPIRIT IV, and A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice (COMPARE) trials in which percutaneous coronary intervention was performed in 6780 patients, 1869 (27.6%) of whom had diabetes mellitus. Patients without diabetes mellitus treated with everolimus-eluting stents compared with paclitaxel-eluting stents had significantly reduced 2-year rates of mortality (1.9% versus 3.1%; P=0.01), myocardial infarction (2.5% versus 5.8%; P<0.0001), stent thrombosis (0.3% versus 2.4%; P<0.0001), and ischemia-driven target lesion revascularization (3.6% versus 6.9%; P<0.0001). In contrast, among patients with diabetes mellitus, there were no significant differences between the 2 stent types in any measured safety or efficacy parameter. Significant interactions were present between diabetic status and stent type for the 2-year end points of myocardial infarction (P=0.01), stent thrombosis (P=0.0006), and target lesion revascularization (P=0.02).
  
  
  CONCLUSIONS
  We have identified a substantial interaction between diabetes mellitus and stent type on clinical outcomes after percutaneous coronary intervention. In patients without diabetes mellitus, everolimus-eluting stents compared with paclitaxel-eluting stents resulted in substantial 2-year reductions in death, myocardial infarction, stent thrombosis, and target lesion revascularization, whereas no significant differences in safety or efficacy outcomes were present in diabetic patients.
authors.affiliation: New York–Presbyterian Hospital, Columbia University Medical Center, The Cardiovascular Research Foundation, New York, NY 10022, USA. gs2184@columbia.edu
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Elvin
authors.initials: E
authors.lastname: Kedhi
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.forename: Martin
authors.initials: M
authors.lastname: Fahy
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D003324:Coronary Artery Disease / Q000628:therapy*; D003925:Diabetic Angiopathies / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D017239:Paclitaxel / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D050257:Tubulin Modulators / Q000627:therapeutic use
chemical_list: D007166:Immunosuppressive Agents; D050257:Tubulin Modulators; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus