The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.
Diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (BMS) implantation as compared with nondiabetics (2). Although drug-eluting stent (DES) implantation significantly reduced the neointimal hyperplasia and angiographic restenosis compared to BMS in diabetic patients (3), presence of diabetes mellitus (DM) have been still associated with an increased risk of restenosis and unfavorable clinical outcomes in the era of DES (4,5). Recently, the relative efficacies of sirolimua-eluting stent (SES) and paclitaxel-eluting stent (PES) in patients with DM have been evaluated in randomized and registry studies (6-10). The present study, ESSENCE-DIABETES Study, compare 8-month angiographic and 1-year clinical outcomes in patients with diabetes mellitus treated with sirolimus-eluting stent (CYPHER) or everolimus-eluting stent (XIENCE V)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Busan Saint Mary's Hospital
Busan, South Korea
Angiographic in-segment late loss at angiography
Time frame: 8-month
All-cause Death
Time frame: 12 month
All-cause Death
Time frame: 5 year
Cardiac death
Time frame: 12 months
Cardiac death
Time frame: 5 year
Myocardial infarction
Time frame: 12 months
Myocardial infarction
Time frame: 5 year
Target vessel revascularization (all and ischemia-driven)
Time frame: 12 months
Target lesion revascularization (all and ischemia-driven)
Time frame: 5 year
Stent thrombosis by definition of Academic Research Consortium (ARC)
Time frame: 12 months
Stent thrombosis by definition of Academic Research Consortium (ARC)
Time frame: 5 year
Binary restenosis in both in-stent and in-segment
Time frame: 8 months
Angiographic pattern of restenosis
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
Cheongju Saint Mary's Hospital
Cheongju-si, South Korea
Kangwon University Hospital
Chuncheon, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Daejeon St Mary's Hospital Catholic University
Daejeon, South Korea
Asan Medical Center
Gangneung, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Kyungsang University Hospital
Jinju, South Korea
...and 8 more locations
Time frame: 8 months