A randomized comparison of sirolimus- versus Paclitaxel-eluting stent implantation in patients with diabetes mellitus.
OBJECTIVE
The aim of this study was to compare the effectiveness of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM).


BACKGROUND
Drug-eluting stent implantation significantly improved the angiographic and clinical outcomes compared with bare-metal stent implantation in diabetic patients. However, comparison of SES with PES in diabetic patients has not been sufficiently evaluated.


METHODS
This prospective, multicenter, randomized study compared SES (n = 200) and PES implantation (n = 200) for diabetic patients (n = 400). The primary end point was in-segment restenosis at 6 months according to intention-to-treat principle.


RESULTS
The 2 groups had similar baseline clinical and angiographic characteristics. Six-month in-stent (3.4% vs. 18.2%, p < 0.001) and in-segment restenosis (4.0% vs. 20.8%, p < 0.001) and 9-month target lesion revascularization (2.0% vs. 7.5%, p = 0.017) were significantly lower in the SES versus the PES group. The incidence of death (0% in SES vs. 0.5% in PES, p = 0.999) or myocardial infarction (0.5% in SES vs. 0.5% in PES, p = 0.999) at 9-month follow-up was not statistically different between the 2 groups. Major adverse cardiac events including death, myocardial infarction, and target lesion revascularization at 9 months (2.0% vs. 8.0%, p = 0.010) were lower in the SES versus the PES group.


CONCLUSIONS
Sirolimus-eluting stent implantation is superior in reducing angiographic restenosis and improving 9-month clinical outcomes in patients with DM and coronary artery disease compared with PES implantation.
Lee
Seung-Whan
SW
Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Park
Seong-Wook
SW
Kim
Young-Hak
YH
Yun
Sung-Cheol
SC
Park
Duk-Woo
DW
Lee
Cheol Whan
CW
Hong
Myeong-Ki
MK
Rhee
Kyoung-Suk
KS
Chae
Jei Keon
JK
Ko
Jae-Ki
JK
Park
Jae-Hyeong
JH
Lee
Jae-Hwan
JH
Choi
Si Wan
SW
Jeong
Jin-Ok
JO
Seong
In-Whan
IW
Cho
Yoon Haeng
YH
Lee
Nae-Hee
NH
Kim
June Hong
JH
Chun
Kook-Jin
KJ
Kim
Hyun-Sook
HS
Park
Seung-Jung
SJ
D000368:Aged; D019917:Blood Vessel Prosthesis Implantation; D015331:Cohort Studies; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D048909:Diabetes Complications / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006083:Graft Occlusion, Vascular / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011859:Radiography; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage*
D007166:Immunosuppressive Agents; D050257:Tubulin Modulators; D017239:Paclitaxel; D020123:Sirolimus