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. 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.
- All Author(s)
- W. J. Kim
; S. W. Lee
; S. W. Park
; Y. H. Kim
; S. C. Yun
; J. Y. Lee
; D. W. Park
; S. J. Kang
; C. W. Lee
; J. H. Lee
; S. W. Choi
; I. W. Seong
; B. K. Lee
; N. H. Lee
; Y. H. Cho
; W. Y. Shin
; S. J. Lee
; M. S. Hyon
; D. W. Bang
; W. J. Park
; H. S. Kim
; J. K. Chae
; K. Lee
; H. K. Park
; C. B. Park
; S. G. Lee
; M. K. Kim
; K. H. Park
; Y. J. Choi
; S. S. Cheong
; T. H. Yang
; J. S. Jang
; S. H. Her
; S. J. Park
; E.-D. S. Investigato
- Issued Date
- 2011
- Type
- Article
- Keyword
- coronary artery disease; drug-eluting stent; diabetes mellitus
- Publisher
- American Heart Association
- ISSN
- 0009-7322
; 1524-4539
- Citation Title
- Circulation
- Citation Volume
- 124
- Citation Number
- 8
- Citation Start Page
- 886
- Citation End Page
- 892
- Language(ISO)
- eng
- DOI
- 10.1161/CIRCULATIONAHA.110.015453
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/1756
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