Safety and efficacy of the CYPHER Select Sirolimus-eluting stent in the "Real World"--clinical and angiographic results from the China CYPHER Select registry.
OBJECTIVE
This post-marketing surveillance registry is aimed at determining the safety and reliability of the CYPHER Select Sirolimus-eluting stent (SES) in routine clinical practice.


BACKGROUND
Little information and angiographic follow-up data in large-scale "real world" registry is available for the CYPHER Select SES, an advanced-generation SES.


METHODS
This was a prospective multicenter (20 centers) registry. 1189 consecutive patients who received at least 1 CYPHER Select SES during daily clinical practice were enrolled. Patients who underwent emergency stenting for acute myocardial infarction were excluded.


RESULTS
The procedure's success rate was 98.3% for CYPHER Select SES implantation, and follow-up rates were 98% with 100% data auditing. Target lesion revascularization (TLR) at 12 months occurred in 60 (5.14%) cases, cardiac death in 13 cases (1.11%), Q wave myocardial infarction (MI) in 5 cases (0.43%), non-Q-MI in 9 cases (0.77%), target vessel revascularization (TVR) in 67 cases (5.74%), and MACE defined as cardiac death, nonfatal MI and TLR in 76 cases (6.51%). MACE-free survival rate at 12 months was 93.7%. Angiographic follow-up at 9 months was performed in 418 (68.3%) lesions treated by CYPHER Select SES. The binary restenosis rate was 4.8% in-stent and 9.6% in-segment. Subgroup analysis showed diabetes, bifurcation lesion and combined use of different stents were independent risk factors of cumulative MACE. In-segment MLD </=2.25 mm at post-procedure and ostial lesion was independent predictors of in-segment restenosis.


CONCLUSIONS
In this registry, the MACE, TLR, angiographic late loss and binary restenosis rates of CYPHER Select SES were similar to those reported in SES randomized trials and "real world" registries. The safety and efficacy of CYPHER Select SES shown in this registry are consistent with those seen in SES studies.
Gao
Run-Lin
RL
Chinese Society of Cardiology, China.
Xu
Bo
B
Lu
Shu-Zheng
SZ
Chen
Ji-Lin
JL
Han
Ya-Ling
YL
Chen
Jun-Zhu
JZ
Gai
Lu-Yue
LY
Ge
Jun-Bo
JB
Wang
Wei-Min
WM
Du
Zhi-Min
ZM
Huo
Yong
Y
Wang
Le-Feng
LF
Gao
Wei
W
Chen
Ji-Yan
JY
He
Ben
B
Jia
Guo-Liang
GL
Yang
Zhi-Jian
ZJ
Cao
Ke-Jiang
KJ
Li
Wei-Min
WM
Shen
Wei-Feng
WF
Wan
Zheng
Z
Huang
De-Jia
DJ
Zhu
Guo-Ying
GY
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002681:China / Q000453:epidemiology; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000453:epidemiology; D023921:Coronary Stenosis / Q000453:epidemiology / Q000628:therapy*; D003328:Coronary Thrombosis / Q000453:epidemiology; D003331:Coronary Vessels / Q000473:pathology; D003920:Diabetes Mellitus / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage
D007166:Immunosuppressive Agents; D020123:Sirolimus