Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions
NCT ID: NCT00418067
Last Updated: 2012-08-21
Study Results
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Basic Information
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COMPLETED
PHASE4
2645 participants
INTERVENTIONAL
2006-10-31
2009-01-31
Brief Summary
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Detailed Description
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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 ug/mm 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 0.3 mm with a low frequency of target lesion revascularization (1%). The clinical outcomes from the ENDEAVOR II (1,500 patients randomized to ABT-578 or bare metal stent) and the ENDEAVOR III (436 patients randomized 3:1 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 (6.0%) and the Cypher (5.3%, p=1.0) 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cypher
Sirolimus-eluting stent
Cypher
Sirolimus-eluting stent
Taxus Liberte
Paclitaxel-eluting stent
Taxus Liberte
Paclitaxel-eluting stent
Endeavor
Zotarolimus-eluting stent
Endeavor
Zotarolimus-eluting stent
Interventions
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Endeavor
Zotarolimus-eluting stent
Cypher
Sirolimus-eluting stent
Taxus Liberte
Paclitaxel-eluting stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Significant coronary artery stenosis (\>50% by visual estimate)
* Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria
• Heparin, Aspirin, Both Clopidogrel and Ticlopidine, Sirolimus, paclitaxel, ABT 578, Stainless steel and/or Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
* Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
* An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 12 months post enrollment.
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
* Patients who have target lesion of in-stent restenosis at the stented segment of drug-eluting stent (in-stent restenosis of bare metal stent can be included).
* Patients with EF\<30%.
* Patients with cardiogenic shock
* Acute STEMI patients within symptom onset \< 12 hours needing primary angioplasty
* Creatinine level \> 3.0mg/dL or dependence on dialysis.
* Severe hepatic dysfunction (AST and ALT \> 3 times upper normal reference values).
* Patients with left main stem stenosis (\>50% by visual estimate)
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Seung-Jung Park
OTHER
Responsible Party
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Seung-Jung Park
Comparison of the Efficacy of Zotarolimus(ABT 578)-Eluting Stent versus Sirolimus-Eluting Stent versus Paclitaxel-Eluting Stent for Coronary Lesions: The Prospective, Randomized, and Multi-center Trial
Principal Investigators
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Seung-Jung Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Locations
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Soonchunhyang University Bucheon Hospital
Bucheon-si, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Asan Medical Center
Gangneung, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
NHIC Ilsan Hospital
Ilsan, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Pusan Natioanal University Hospital
Pusan, , South Korea
Hallym University Sacred Heart Hospital
Pyeongchon, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
St.Mary's Catholic Medical Center
Seoul, , South Korea
Yonsei University Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Yonsei University Wonju Christian Hospital
Wŏnju, , South Korea
Countries
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References
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Kang SJ, Mintz GS, Park DW, Lee SW, Kim YH, Lee CW, Han KH, Kim JJ, Park SW, Park SJ. Comparison of zotarolimus-eluting stents with sirolimus-eluting and paclitaxel-eluting stents: intimal hyperplasia and vascular changes assessed by volumetric intravascular ultrasound analysis. Circ Cardiovasc Interv. 2011 Apr 1;4(2):139-45. doi: 10.1161/CIRCINTERVENTIONS.110.957936. Epub 2011 Mar 1.
Park DW, Kim YH, Yun SC, Kang SJ, Lee SW, Lee CW, Park SW, Seong IW, Lee JH, Tahk SJ, Jeong MH, Jang Y, Cheong SS, Yang JY, Lim DS, Seung KB, Chae JK, Hur SH, Lee SG, Yoon J, Lee NH, Choi YJ, Kim HS, Kim KS, Kim HS, Hong TJ, Park HS, Park SJ. Comparison of zotarolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for coronary revascularization: the ZEST (comparison of the efficacy and safety of zotarolimus-eluting stent with sirolimus-eluting and paclitaxel-eluting stent for coronary lesions) randomized trial. J Am Coll Cardiol. 2010 Oct 5;56(15):1187-95. doi: 10.1016/j.jacc.2010.03.086.
Other Identifiers
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2006-0136
Identifier Type: -
Identifier Source: org_study_id