Comparison of Zotarolimus-Eluting stent versus Sirolimus-Eluting stent for de novo coronary artery disease in patients with diabetes mellitus from the ESSENCE-DIABETES II trial.
Angiographic and clinical outcomes remain relatively unfavorable for diabetic patients even after the use of drug-eluting stent. This prospective, multicenter, randomized study compared the relative efficacy and safety of resolute zotarolimus-eluting stent (R-ZES) and sirolimus-eluting stent (SES) implantation in diabetic patients with coronary artery disease. The primary end point was noninferiority of angiographic in-segment late loss at 9 months. Clinical events were also monitored for at least 12 months. Patient recruitment was prematurely stopped after enrollment of 256 patients (127 in R-ZES group and 129 in SES) because of discontinuing production of SES. The R-ZES was noninferior to the SES for 9-month in-segment late loss (0.34 ± 0.30 vs 0.39 ± 0.43 mm; difference -0.048; 95% confidence interval -0.157 to 0.061; upper 1-sided 95% confidence interval 0.044; p <0.001 for noninferiority). In addition, in-stent late loss (0.22 ± 0.29 vs 0.21 ± 0.40 mm, p = 0.849) and the rates of in-segment (1.2% vs 6.7%, p = 0.119) and in-stent (1.2% vs 3.3%, p = 0.621) binary restenoses were similar between the 2 groups. At 12 months, there were no statistical differences between the 2 groups in the incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, ischemia-driven target lesion revascularization, ischemia-driven target vessel revascularization, and composite outcomes). In conclusion, despite having reduced power because of early study termination, our study suggests that the R-ZES has noninferior angiographic outcomes at 9 months to the SES in diabetic patients with coronary artery disease.
Department of Cardiology, Daejeon St. Mary's Hospital, The Catholic University of Korea, Daejeon, Korea.
Gyung-Min
GM
Park
Seung-Whan
SW
Lee
Seong-Wook
SW
Park
Young-Hak
YH
Kim
Sung-Cheol
SC
Yun
Young-Rak
YR
Cho
Jung-Min
JM
Ahn
Jong-Young
JY
Lee
Won-Jang
WJ
Kim
Duk-Woo
DW
Park
Soo-Jin
SJ
Kang
Cheol Whan
CW
Lee
Bong-Ki
BK
Lee
Nae-Hee
NH
Lee
Yoon Haeng
YH
Cho
Jon
J
Suh
Won-Yong
WY
Shin
Seung-Jin
SJ
Lee
Se-Whan
SW
Lee
Woo-Jung
WJ
Park
Hyun-Sook
HS
Kim
Sang-Gon
SG
Lee
Sang-Sig
SS
Cheong
Sung Ho
SH
Her
Mahn-Won
MW
Park
Chan Joon
CJ
Kim
Seung-Jung
SJ
Park
D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D003920:Diabetes Mellitus; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; C489443:zotarolimus; D020123:Sirolimus