title: Safety and efficacy of a bioabsorbable polymer-coated, everolimus-eluting coronary stent in patients with diabetes: the EVOLVE II diabetes substudy.
abstract: OBJECTIVE
  Bioabsorbable polymer drug-eluting stents (DES) may reduce the inflammation and delayed healing associated with some permanent polymer-coated DES. Whether late clinical outcomes are improved, particularly among patients with medically treated diabetes, is unknown. Therefore, we analysed outcomes from a pre-specified substudy of the EVOLVE II trial to evaluate the safety and effectiveness of the SYNERGY stent in patients with diabetes mellitus.
  
  
  RESULTS
  SYNERGY is a thin-strut, platinum-chromium everolimus-eluting stent with an ultra-thin bioabsorbable poly(DL-lactide-co-glycolide) abluminal polymer. The EVOLVE II randomised, controlled trial proved the non-inferiority of the SYNERGY versus the PROMUS Element Plus stent for one-year target lesion failure (TLF: ischaemia-driven target lesion revascularisation [ID-TLR], target vessel myocardial infarction [TVMI], or cardiac death). The pre-specified EVOLVE II diabetes substudy prospectively pooled randomised patients with diabetes (N=263) with a sequential single-arm diabetic cohort (n=203). The substudy primary endpoint was one-year TLF compared with a pre-specified performance goal (14.5%). The primary endpoint occurred in 7.5% of SYNERGY-treated patients with diabetes, significantly less than the performance goal (p<0.0001). The two-year rate of TLF was 11.2% (cardiac death 1.5%, TVMI 6.4%, ID-TLR 6.8%) and definite/probable stent thrombosis occurred in 1.1% of patients.
  
  
  CONCLUSIONS
  The EVOLVE II diabetes substudy demonstrates the efficacy and safety of the SYNERGY stent in patients with medically treated diabetes.
authors.affiliation: The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH, USA.
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.forename: Monica
authors.initials: M
authors.lastname: Masotti
authors.forename: Didier
authors.initials: D
authors.lastname: Carrié
authors.forename: Raul
authors.initials: R
authors.lastname: Moreno
authors.forename: Andrejs
authors.initials: A
authors.lastname: Erglis
authors.forename: Shamir R
authors.initials: SR
authors.lastname: Mehta
authors.forename: Simon
authors.initials: S
authors.lastname: Elhadad
authors.forename: Jacques
authors.initials: J
authors.lastname: Berland
authors.forename: Bernardo
authors.initials: B
authors.lastname: Stein
authors.forename: Juhani
authors.initials: J
authors.lastname: Airaksinen
authors.forename: R Lee
authors.initials: RL
authors.lastname: Jobe
authors.forename: Arthur
authors.initials: A
authors.lastname: Reitman
authors.forename: Luc
authors.initials: L
authors.lastname: Janssens
authors.forename: Thomas
authors.initials: T
authors.lastname: Christen
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects; D000368:Aged; D000369:Aged, 80 and over; D003643:Death; D048909:Diabetes Complications; D003920:Diabetes Mellitus; D054855:Drug-Eluting Stents / Q000009:adverse effects; D000068338:Everolimus / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011108:Polymers / Q000009:adverse effects; D020123:Sirolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus