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

被引:88
作者
Kim, Won-Jang
Lee, Seung-Whan
Park, Seong-Wook
Kim, Young-Hak
Yun, Sung-Cheol
Lee, Jong-Young
Park, Duk-Woo
Kang, Soo-Jin
Lee, Cheol Whan
Lee, Jae-Hwan [2 ]
Choi, Si Wan [2 ]
Seong, In-Whan [2 ]
Lee, Bong-Ki [3 ]
Lee, Nae-Hee [4 ]
Cho, Yoon Haeng [4 ]
Shin, Won-Yong [5 ]
Lee, Seung-Jin [5 ]
Lee, Se-Whan [5 ]
Hyon, Min-Su [6 ]
Bang, Duk-Won [6 ]
Park, Woo-Jung [7 ]
Kim, Hyun-Sook [7 ]
Chae, Jei Keon [8 ]
Lee, Keun [9 ]
Park, Hoon-Ki [9 ]
Park, Chang-Bum [9 ]
Lee, Sang-Gon [10 ]
Kim, Min-Kyu [11 ]
Park, Kyoung-Ha [11 ]
Choi, Young-Jin [11 ]
Cheong, Sang-Sig [12 ]
Yang, Tae-Hyun [13 ]
Jang, Jae-Sik [13 ]
Her, Sung Ho [14 ]
Park, Seung-Jung [1 ]
机构
[1] Univ Ulsan, Coll Med, Dept Cardiol, Cardiac Ctr,Asan Med Ctr, Seoul 138736, South Korea
[2] Chungnam Natl Univ Hosp, Taejon, South Korea
[3] Kangwon Natl Univ Hosp, Chunchon, South Korea
[4] Soonchunhyang Univ, Bucheon Hosp, Puchon, South Korea
[5] Soonchunhyang Univ, Cheonan Hosp, Cheonan, South Korea
[6] Soon Chun Hyang Univ Hosp, Seoul, South Korea
[7] Hallym Univ, Sacred Heart Hosp, Pyongchon, South Korea
[8] ChonBuk Natl Univ Hosp, Jeonju, South Korea
[9] Seoul Vet Hosp, Seoul, South Korea
[10] Ulsan Univ Hosp, Ulsan, South Korea
[11] Hangang Sacred Heart Hosp, Seoul, South Korea
[12] Univ Ulsan, Coll Med, Gangneung Asan Hosp, Kangnung, South Korea
[13] Inje Univ, Pusan Paik Hosp, Pusan, South Korea
[14] Catholic Univ Korea, Daejeon St Marys Hosp, Taejon, South Korea
关键词
coronary artery disease; drug-eluting stent; diabetes mellitus; INTRAVASCULAR ULTRASOUND ANALYSIS; NONDIABETIC PATIENTS; CLINICAL-OUTCOMES; RESTENOSIS; REVASCULARIZATION; MULTICENTER; REGISTRY; SYSTEM;
D O I
10.1161/CIRCULATIONAHA.110.015453
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:886 / U84
页数:11
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