Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418067
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2007-01-03
Brief Title:
Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions
Sponsor:
Seung-Jung Park
Organization:
CardioVascular Research Foundation Korea
Study Overview
Official Title:
Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZEST
Brief Summary:
The purpose of this study is to establish the safety and long-term effectiveness of coronary stenting with the ABT 578-eluting balloon expandable stent Medtronic Minneapolis MN vs the sirolimus-eluting balloon expandable stent Cordis Johnson Johnson Warren New Jersey and the paclitaxel-eluting stent Taxus liberte Boston Scientific for the treatment of coronary stenosis in routine clinical practice
Detailed Description:
Previous studies have documented that a slow-release polymeric sirolimus-eluting stent Cypher Cordis and paclitaxel-eluting stent Taxus Boston Scientific reduce neointimal formation and result in decrease of angiographic restenosis and target lesion revascularization at 1-3 years in the multicenter randomized clinical trials RAVEL SIRIUS and TAXUS I-VIFrom these studies the two leading drug-eluting stents DESs of the Cypher and Taxus have been widely and rapidly accepted as a standard treatment of coronary lesions
Recently randomized studies were conducted to reveal different outcomes of the different two DESs These studies showed that the sirolimus-eluting stent was better than the paclitaxel-eluting stent in terms of lower angiographic restenosis rate or the two DESs were similar in angiographic outcomes A recent meta-analysis supported results of the former randomized studies Patients receiving sirolimus-eluting stent had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stent
With a recent approval of new DES ABT-578-eluting stent Endeavor Medtronic Minneapolis MN other comparison studies have been conducted to compare Endeavor ABT-578-eluting stent with the sirolimus-eluting stent and paclitaxel-eluting stent ABT-578 and sirolimus share some common structural and biological properties The ENDEAVOR clinical trials are currently in progress to evaluate a phosphoryl choline PC-coated ABT-578-eluting stent for the prevention of restenosis The Endeavor ABT-578-eluting stent utilizes a cobalt alloy balloon-expandable stent Driver Medtronic with a geometry similar to the stainless steel stent used in this preliminary study S7 Medtronic The Endeavor ABT-578-eluting stent also employees a PC strut surface coating as the drug delivery reservoir with a dose of 10 ugmm of ABT-578 The Endeavor ABT-578-eluting stent however differs from the stent used in this experimental study by the addition of a drug-free PC coating to serve as a diffusion barrier to retard drug release from the polymer reservoir Angiographic analysis at 4 months in the 100-patient focal de novo lesion ENDEAVOR I feasibility study demonstrated a mean in-stent percent diameter stenosis of approximately 14 and a late lumen loss of 03 mm with a low frequency of target lesion revascularization 1 The clinical outcomes from the ENDEAVOR II 1500 patients randomized to ABT-578 or bare metal stent and the ENDEAVOR III 436 patients randomized 31 to ABT-578 or Cypher trials as well as other ongoing studies showed efficacy of the PC-coated ABT-578-eluting stent In ENDEAVOR III study the Endeavor stent had larger late loss and higher binary restenosis in both the analysis segment and stented segment In contrast the TLR rates are not statistically different between the Endeavor 60 and the Cypher 53 p10 stents This result of this study raised several questions to warrant further randomized studies 1 is the angiographic superiority of Cypher stent applied to the more complex lesions 2 why is the TLR rate similar in spite of significantly different angiographic outcomes 3 which is better in the Endeavor and the Taxus stents etc The ENDEAVOR IV study is being conducted to compare the safety and efficacy of the Endeavor stent versus the Taxus stent However the inclusion of ENDEAVOR IV study was also limited that this study did not include all complex lesions Because of the limitations of current ENDEAVOR series a further large randomized study for the concurrent comparison of the three DESs in the treatment of real-world practice would be needed
Recently randomized studies were conducted to reveal different outcomes of the different two DESs These studies showed that the sirolimus-eluting stent was better than the paclitaxel-eluting stent in terms of lower angiographic restenosis rate or the two DESs were similar in angiographic outcomes A recent meta-analysis supported results of the former randomized studies Patients receiving sirolimus-eluting stent had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stent
With a recent approval of new DES ABT-578-eluting stent Endeavor Medtronic Minneapolis MN other comparison studies have been conducted to compare Endeavor ABT-578-eluting stent with the sirolimus-eluting stent and paclitaxel-eluting stent ABT-578 and sirolimus share some common structural and biological properties The ENDEAVOR clinical trials are currently in progress to evaluate a phosphoryl choline PC-coated ABT-578-eluting stent for the prevention of restenosis The Endeavor ABT-578-eluting stent utilizes a cobalt alloy balloon-expandable stent Driver Medtronic with a geometry similar to the stainless steel stent used in this preliminary study S7 Medtronic The Endeavor ABT-578-eluting stent also employees a PC strut surface coating as the drug delivery reservoir with a dose of 10 ugmm of ABT-578 The Endeavor ABT-578-eluting stent however differs from the stent used in this experimental study by the addition of a drug-free PC coating to serve as a diffusion barrier to retard drug release from the polymer reservoir Angiographic analysis at 4 months in the 100-patient focal de novo lesion ENDEAVOR I feasibility study demonstrated a mean in-stent percent diameter stenosis of approximately 14 and a late lumen loss of 03 mm with a low frequency of target lesion revascularization 1 The clinical outcomes from the ENDEAVOR II 1500 patients randomized to ABT-578 or bare metal stent and the ENDEAVOR III 436 patients randomized 31 to ABT-578 or Cypher trials as well as other ongoing studies showed efficacy of the PC-coated ABT-578-eluting stent In ENDEAVOR III study the Endeavor stent had larger late loss and higher binary restenosis in both the analysis segment and stented segment In contrast the TLR rates are not statistically different between the Endeavor 60 and the Cypher 53 p10 stents This result of this study raised several questions to warrant further randomized studies 1 is the angiographic superiority of Cypher stent applied to the more complex lesions 2 why is the TLR rate similar in spite of significantly different angiographic outcomes 3 which is better in the Endeavor and the Taxus stents etc The ENDEAVOR IV study is being conducted to compare the safety and efficacy of the Endeavor stent versus the Taxus stent However the inclusion of ENDEAVOR IV study was also limited that this study did not include all complex lesions Because of the limitations of current ENDEAVOR series a further large randomized study for the concurrent comparison of the three DESs in the treatment of real-world practice would be needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None