Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: the EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) randomized trial.
OBJECTIVE
The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner.


BACKGROUND
EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined.


METHODS
This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee.


RESULTS
Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38).


CONCLUSIONS
EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607).
Cardiovascular Center, Seoul National University Main Hospital, Chongno-gu, Seoul, Korea.
Kyung Woo
KW
Park
In-Ho
IH
Chae
Do-Sun
DS
Lim
Kyoo-Rok
KR
Han
Han-Mo
HM
Yang
Hae-Young
HY
Lee
Hyun-Jae
HJ
Kang
Bon-Kwon
BK
Koo
Taehoon
T
Ahn
Jung-Han
JH
Yoon
Myung-Ho
MH
Jeong
Taek-Jong
TJ
Hong
Woo-Young
WY
Chung
Sang-Ho
SH
Jo
Young-Jin
YJ
Choi
Seung-Ho
SH
Hur
Hyuck-Moon
HM
Kwon
Dong-Woon
DW
Jeon
Byung-Ok
BO
Kim
Si-Hoon
SH
Park
Nam-Ho
NH
Lee
Hui-Kyung
HK
Jeon
Hyeon-Cheol
HC
Gwon
Yang-Soo
YS
Jang
Hyo-Soo
HS
Kim
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003327:Coronary Disease / Q000628:therapy; D023903:Coronary Restenosis / Q000453:epidemiology; D054855:Drug-Eluting Stents; D000068338:Everolimus; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011475:Prosthesis Failure; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*
D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus