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

Won Jang Kim, Seung Whan Lee, Seong Wook Park, Young Hak Kim, Sung Cheol Yun, Jong Young Lee, Duk Woo Park, Soo Jin Kang, Cheol Whan Lee, Jae Hwan Lee, Si Wan Choi, In Whan Seong, Bong Ki Lee, Nae Hee Lee, Yoon Haeng Cho, Won Yong Shin, Seung Jin Lee, Se Whan Lee, Min Su Hyon, Duk Won BangWoo Jung Park, Hyun Sook Kim, Jei Keon Chae, Keun Lee, Hoon Ki Park, Chang Bum Park, Sang Gon Lee, Min Kyu Kim, Kyoung Ha Park, Young Jin Choi, Sang Sig Cheong, Tae Hyun Yang, Jae Sik Jang, Sung Ho Her, Seung Jung Park

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106 Scopus citations

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. Methods and 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.

Original languageEnglish
Pages (from-to)886-892
Number of pages7
JournalCirculation
Volume124
Issue number8
DOIs
StatePublished - 23 Aug 2011

Keywords

  • coronary artery disease
  • diabetes mellitus
  • drug-eluting stent

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