title: Randomized comparison of everolimus-eluting stent versus sirolimus-eluting stent implantation for de novo coronary artery disease in patients with diabetes mellitus (ESSENCE-DIABETES): results from the ESSENCE-DIABETES trial.
abstract: BACKGROUND
  Drug-eluting stents significantly improved angiographic and clinical outcomes compared with bare metal stents in diabetic patients. However, a comparison of everolimus-eluting stents and sirolimus-eluting stents in diabetic patients has not been evaluated. Therefore we compared effectiveness of everolimus-eluting stents and sirolimus-eluting stents in patients with diabetes mellitus.
  
  
  RESULTS
  This prospective, multicenter, randomized study compared everolimus-eluting stent (n=149) and sirolimus-eluting stent (n=151) implantation in diabetic patients. The primary end point was noninferiority of angiographic in-segment late loss at 8 months. Clinical events were also monitored for at least 12 months. Everolimus-eluting stents were noninferior to sirolimus-eluting stents for 8-month in-segment late loss (0.23 ± 0.27 versus 0.37 ± 0.52 mm; difference, -0.13 mm; 95% confidence interval, -0.25 to -0.02; upper 1-sided 95% confidence interval, -0.04; P<0.001 for noninferiority), with reductions in in-stent restenosis (0% versus 4.7%; P=0.029) and in-segment restenosis (0.9% versus 6.5%; P=0.035). However, in-stent late loss (0.11 ± 0.26 versus 0.20 ± 0.49 mm; P=0.114) was not statistically different between the 2 groups. At 12 months, ischemia-driven target lesion revascularization (0.7% versus 2.6%; P=0.317), death (1.3% versus 3.3%; P=0.448), and myocardial infarction (0% versus 1.3%; P=0.498) were not statistically different between the 2 groups. Major adverse cardiac events, including death, myocardial infarction, and ischemia-driven target lesion revascularization (2.0% versus 5.3%; P=0.218), were also not statistically different between the 2 groups.
  
  
  CONCLUSIONS
  Everolimus-eluting stents were noninferior to sirolimus-eluting stents in reducing in-segment late loss and reduced angiographic restenosis at 8 months in patients with diabetes mellitus and coronary artery disease.
authors.affiliation: Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Won-Jang
authors.initials: WJ
authors.lastname: Kim
authors.forename: Seung-Whan
authors.initials: SW
authors.lastname: Lee
authors.forename: Seong-Wook
authors.initials: SW
authors.lastname: Park
authors.forename: Young-Hak
authors.initials: YH
authors.lastname: Kim
authors.forename: Sung-Cheol
authors.initials: SC
authors.lastname: Yun
authors.forename: Jong-Young
authors.initials: JY
authors.lastname: Lee
authors.forename: Duk-Woo
authors.initials: DW
authors.lastname: Park
authors.forename: Soo-Jin
authors.initials: SJ
authors.lastname: Kang
authors.forename: Cheol Whan
authors.initials: CW
authors.lastname: Lee
authors.forename: Jae-Hwan
authors.initials: JH
authors.lastname: Lee
authors.forename: Si Wan
authors.initials: SW
authors.lastname: Choi
authors.forename: In-Whan
authors.initials: IW
authors.lastname: Seong
authors.forename: Bong-Ki
authors.initials: BK
authors.lastname: Lee
authors.forename: Nae-Hee
authors.initials: NH
authors.lastname: Lee
authors.forename: Yoon Haeng
authors.initials: YH
authors.lastname: Cho
authors.forename: Won-Yong
authors.initials: WY
authors.lastname: Shin
authors.forename: Seung-Jin
authors.initials: SJ
authors.lastname: Lee
authors.forename: Se-Whan
authors.initials: SW
authors.lastname: Lee
authors.forename: Min-Su
authors.initials: MS
authors.lastname: Hyon
authors.forename: Duk-Won
authors.initials: DW
authors.lastname: Bang
authors.forename: Woo-Jung
authors.initials: WJ
authors.lastname: Park
authors.forename: Hyun-Sook
authors.initials: HS
authors.lastname: Kim
authors.forename: Jei Keon
authors.initials: JK
authors.lastname: Chae
authors.forename: Keun
authors.initials: K
authors.lastname: Lee
authors.forename: Hoon-Ki
authors.initials: HK
authors.lastname: Park
authors.forename: Chang-Bum
authors.initials: CB
authors.lastname: Park
authors.forename: Sang-Gon
authors.initials: SG
authors.lastname: Lee
authors.forename: Min-Kyu
authors.initials: MK
authors.lastname: Kim
authors.forename: Kyoung-Ha
authors.initials: KH
authors.lastname: Park
authors.forename: Young-Jin
authors.initials: YJ
authors.lastname: Choi
authors.forename: Sang-Sig
authors.initials: SS
authors.lastname: Cheong
authors.forename: Tae-Hyun
authors.initials: TH
authors.lastname: Yang
authors.forename: Jae-Sik
authors.initials: JS
authors.lastname: Jang
authors.forename: Sung Ho
authors.initials: SH
authors.lastname: Her
authors.forename: Seung-Jung
authors.initials: SJ
authors.lastname: Park
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control; D003925:Diabetic Angiopathies / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus