Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial: study design and rationale of a Korean multicenter prospective randomized trial.
BACKGROUND
The everolimus-eluting stent (EES) is a newly developed drug-eluting stent using the MULTILINK VISION stent platform combined with the drug everolimus contained in a polymer coating. Recently reported randomized trials have shown the noninferiority and subsequent superiority of the EES compared with the paclitaxel-eluting stent regarding in-stent late loss (LL) at 180 days. However, there have been no studies comparing head to head the EES with the sirolimus-eluting stent (SES), which has shown the least amount of LL among the previously released drug-eluting stent (DES). In addition, adjunctive antiplatelet therapy is a critical factor in optimizing long-term DES safety. Despite the recommendation of the American Heart Association/American College of Cardiology to maintain 12 months of dual antiplatelet therapy, there have been no prospective randomized trials comparing the efficacy and safety of different durations.


METHODS
In the Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial, approximately 1,400 patients are being prospectively and randomly assigned in a 2 x 2 factorial design according to the type of stent (EES vs SES) and the duration of dual antiplatelet therapy (6 vs 12 months). The primary end point is in-segment LL at 9 months for comparison of type of stent, and the coprimary end point is target vessel failure at 12 months for comparison of dual antiplatelet therapy duration.


CONCLUSIONS
The EXCELLENT trial is the largest study yet performed to directly compare the efficacy and safety of the EES versus the SES. In addition, this study will also address the issue of a 6- versus 12-month duration of dual antiplatelet therapy for post-percutaneous coronary intervention management.
Park
Kyung Woo
KW
Cardiovascular Center, Seoul National University Main Hospital, Seoul, South Korea.
Yoon
Jung-Han
JH
Kim
Jung-Sun
JS
Hahn
Joo-Yong
JY
Cho
Young-Seok
YS
Chae
In-Ho
IH
Gwon
Hyeon-Cheol
HC
Ahn
Taehoon
T
Oh
Byung-Hee
BH
Park
Jeong-Euy
JE
Shim
Won-Heum
WH
Shin
Eak-Kyun
EK
Jang
Yang-Soo
YS
Kim
Hyo-Soo
HS
D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D054855:Drug-Eluting Stents / Q000592:standards*; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000150:complications / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology*; D015994:Incidence; D007723:Korea / Q000453:epidemiology; D008297:Male; D009204:Myocardial Revascularization / Q000295:instrumentation*; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology*; D013997:Time Factors; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus