Efficacies of the new paclitaxel-eluting Coroflex Please stent in percutaneous coronary intervention; comparison of efficacy between Coroflex Please and Taxus (ECO-PLEASANT) trial: study rationale and design.
BACKGROUND
Previous randomized trials have showed the superiority of Paclitaxel-eluting stent over bare metal stent in angiographic and clinical outcomes. Coroflex Please stent is a newly developed drug eluting stent using the Coroflex stent platform combined with the drug paclitaxel contained in a polymer coating. PECOPS I trial, one-arm observational study, showed that the clinical and angiographic outcomes of Coroflex Please stent were within the range of those of Taxus, the 1st generation paclitaxel-eluting stent (PES). However, there have been no studies directly comparing the Coroflex Please stent with the Taxus Liberte stent that is the newest version of Taxus. Therefore, prospective, randomized trial is required to demonstrate the non-inferiority of Coroflex Please stent compared with Taxus Liberte stent in a head-to-head manner.


METHODS
In the comparison of Efficacy between COroflex PLEASe ANd Taxus stent(ECO-PLEASANT) trial, approximately 900 patients are being prospectively and randomly assigned to the either type of Coroflex Please stent and Taxus Liberte stent via web-based randomization. The primary endpoint is clinically driven target vessel revascularization at 9 months. The secondary endpoints include major cardiac adverse events, target vessel failure, stent thrombosis and angiographic efficacy endpoints.


CONCLUSIONS
The ECO-PLEASANT trial is the study not yet performed to directly compare the efficacy and safety of the Coroflex Please versus Taxus Liberte stent. On the basis of this trial, we will be able to find out whether the Coroflex Please stent is non-inferior to Taxus Liberte stent or not.


BACKGROUND
ClinicalTrials.gov number, NCT00699543.
Seo
Jae-Bin
JB
Cardiovascular Center, Seoul National University Hospital, Seoul, Korea. cetuximab@empal.com
Jeon
Hui-Kyung
HK
Park
Kyung-Woo
KW
Park
Jong-Seon
JS
Bae
Jang-Ho
JH
Kim
Sang-Wook
SW
Moon
Keon-Woong
KW
Choi
Jae-Woong
JW
Lee
Sang-Gon
SG
Chung
Woo-Young
WY
Youn
Tae-Jin
TJ
Kim
Soo-Joong
SJ
Kim
Doo-Il
DI
Kim
Byung-Ok
BO
Hyon
Min-Su
MS
Park
Keum-Soo
KS
Cha
Tae-Joon
TJ
Hwang
Hweung-Kon
HK
Hur
Seung-Ho
SH
Kim
Hyo-Soo
HS
D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D005500:Follow-Up Studies; D006801:Humans; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D012107:Research Design; D018401:Sample Size
D017239:Paclitaxel