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Randomized Controlled Trial Multicenter Study Comparative Study
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 Bang, Woo-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, and ESSENCE-DIABETES Study Investigators.
- Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
- Circulation. 2011 Aug 23; 124 (8): 886-92.
BackgroundDrug-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 ResultsThis 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.ConclusionEverolimus-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.
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