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.

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; Choi, Si Wan; Seong, In-Whan; Lee, Bong-Ki; Lee, Nae-Hee; Cho, Yoon Haeng; Shin, Won-Yong; Lee, Seung-Jin; Lee, Se-Whan; Hyon, Min-Su; Bang, Duk-Won; Park, Woo-Jung; Kim, Hyun-Sook; Chae, Jei Keon; Lee, Keun; Park, Hoon-Ki; Park, Chang-Bum; Lee, Sang-Gon; Kim, Min-Kyu; Park, Kyoung-Ha; Choi, Young-Jin; Cheong, Sang-Sig; Yang, Tae-Hyun; Jang, Jae-Sik; Her, Sung Ho; Park, Seung-Jung
Circulation
2011Aug ; 124 ( 8 ) :886-92.
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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 -
Choi, Si Wan -
Seong, In-Whan -
Lee, Bong-Ki -
Lee, Nae-Hee -
Cho, Yoon Haeng -
Shin, Won-Yong -
Lee, Seung-Jin -
Lee, Se-Whan -
Hyon, Min-Su -
Bang, Duk-Won -
Park, Woo-Jung -
Kim, Hyun-Sook -
Chae, Jei Keon -
Lee, Keun -
Park, Hoon-Ki -
Park, Chang-Bum -
Lee, Sang-Gon -
Kim, Min-Kyu -
Park, Kyoung-Ha -
Choi, Young-Jin -
Cheong, Sang-Sig -
Yang, Tae-Hyun -
Jang, Jae-Sik -
Her, Sung Ho -
Park, Seung-Jung -
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. CONCLUSION: 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.
coronary artery disease; drug-eluting stent; diabetes mellitus
MESH
Adolescent, Adult, Aged, Angioplasty, Balloon, Coronary/adverse effects/*methods, Coronary Artery Disease/*therapy, Coronary Restenosis/prevention & control, Diabetic Angiopathies/*therapy, *Drug-Eluting Stents, Everolimus, Female, Follow-Up Studies, Humans, Immunosuppressive Agents/therapeutic use, Male, Middle Aged, Prospective Studies, Sirolimus/*analogs & derivatives/*therapeutic use, Treatment Outcome, Young Adult
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It is unclear whether there are differences in efficacy and safety between EES and SES in diabetic patients.
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DOI
10.1161/CIRCULATIONAHA.110.015453
KCDÄÚµå
ICD 03
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