Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Sirolimus-eluting stent
Paclitaxel-eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring Coronary Revascularization, Sirolimus-eluting stents, Paclitaxel-eluting stents
Eligibility Criteria
Inclusion Criteria: Patients with either stable angina or an acute coronary syndrome were eligible to participate if they had at least one lesion with stenosis of at least 50 percent in a vessel with a reference diameter between 2.25 and 4.00 mm that was suitable for stent implantation. Exclusion Criteria: Allergy to antiplatelet drugs, heparin, stainless steel, contrast agents, sirolimus, or paclitaxel; participation in another coronary-device study; and terminal illness.
Sites / Locations
- University Hospital Bern
Outcomes
Primary Outcome Measures
Major adverse cardiac events at nine months (composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization)
Secondary Outcome Measures
Clinical: Ischemia-driven target lesion revascularization, target-vessel revascularization, and target-vessel failure (composite of cardiac death, myocardial infarction or ischemia-driven target-vessel revascularization)
Angiographic: In-segment late luminal loss
Full Information
NCT ID
NCT00297661
First Posted
February 22, 2006
Last Updated
October 19, 2006
Sponsor
University of Bern
Collaborators
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT00297661
Brief Title
Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization
Official Title
Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization: SIRTAX Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bern
Collaborators
University of Zurich
4. Oversight
5. Study Description
Brief Summary
Context: Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, reduce the risk of restenosis. It is unclear whether there are differences in safety and efficacy between the two types of drug-eluting stents.
Objective: To determine differences in safety and efficacy between sirolimus and paclitaxel eluting stents.
Detailed Description
Design: Randomized controlled, observer-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents
Patients: 1012 patients undergoing percutaneous coronary intervention. The two groups had similar baseline clinical and angiographic characteristics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Coronary Revascularization, Sirolimus-eluting stents, Paclitaxel-eluting stents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
1012 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Sirolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Paclitaxel-eluting stent
Primary Outcome Measure Information:
Title
Major adverse cardiac events at nine months (composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization)
Secondary Outcome Measure Information:
Title
Clinical: Ischemia-driven target lesion revascularization, target-vessel revascularization, and target-vessel failure (composite of cardiac death, myocardial infarction or ischemia-driven target-vessel revascularization)
Title
Angiographic: In-segment late luminal loss
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with either stable angina or an acute coronary syndrome were eligible to participate if they had at least one lesion with stenosis of at least 50 percent in a vessel with a reference diameter between 2.25 and 4.00 mm that was suitable for stent implantation.
Exclusion Criteria:
Allergy to antiplatelet drugs, heparin, stainless steel, contrast agents, sirolimus, or paclitaxel; participation in another coronary-device study; and terminal illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, MD
Organizational Affiliation
Department of Cardiology, University Hospital Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Juni, MD
Organizational Affiliation
Department of Social and Preventive Medicine, University of Bern
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bernhard Meier, MD
Organizational Affiliation
Department of Cardiology, University Hospital Bern
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
16105989
Citation
Windecker S, Remondino A, Eberli FR, Juni P, Raber L, Wenaweser P, Togni M, Billinger M, Tuller D, Seiler C, Roffi M, Corti R, Sutsch G, Maier W, Luscher T, Hess OM, Egger M, Meier B. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med. 2005 Aug 18;353(7):653-62. doi: 10.1056/NEJMoa051175. Epub 2005 Aug 16.
Results Reference
result
PubMed Identifier
27578808
Citation
Yamaji K, Raber L, Zanchin T, Spitzer E, Zanchin C, Pilgrim T, Stortecky S, Moschovitis A, Billinger M, Schonenberger C, Eberli F, Juni P, Luscher TF, Heg D, Windecker S. Ten-year clinical outcomes of first-generation drug-eluting stents: the Sirolimus-Eluting vs. Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) VERY LATE trial. Eur Heart J. 2016 Dec 1;37(45):3386-3395. doi: 10.1093/eurheartj/ehw343. Epub 2016 Aug 30.
Results Reference
derived
PubMed Identifier
26823484
Citation
Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Raber L, Heg D, Juni P, Windecker S. Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients. Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255.
Results Reference
derived
PubMed Identifier
24531331
Citation
Vranckx P, Kalesan B, Stefanini GG, Farooq V, Onuma Y, Silber S, de Vries T, Juni P, Serruys PW, Windecker S. Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention. EuroIntervention. 2015 Jun;11(2):171-9. doi: 10.4244/EIJV11I2A31.
Results Reference
derived
PubMed Identifier
22440496
Citation
Stefanini GG, Kalesan B, Pilgrim T, Raber L, Onuma Y, Silber S, Serruys PW, Meier B, Juni P, Windecker S. Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents. JACC Cardiovasc Interv. 2012 Mar;5(3):301-10. doi: 10.1016/j.jcin.2011.11.011.
Results Reference
derived
PubMed Identifier
21951630
Citation
Girasis C, Garg S, Raber L, Sarno G, Morel MA, Garcia-Garcia HM, Luscher TF, Serruys PW, Windecker S. SYNTAX score and Clinical SYNTAX score as predictors of very long-term clinical outcomes in patients undergoing percutaneous coronary interventions: a substudy of SIRolimus-eluting stent compared with pacliTAXel-eluting stent for coronary revascularization (SIRTAX) trial. Eur Heart J. 2011 Dec;32(24):3115-27. doi: 10.1093/eurheartj/ehr369. Epub 2011 Sep 27.
Results Reference
derived
PubMed Identifier
21646500
Citation
Raber L, Wohlwend L, Wigger M, Togni M, Wandel S, Wenaweser P, Cook S, Moschovitis A, Vogel R, Kalesan B, Seiler C, Eberli F, Luscher TF, Meier B, Juni P, Windecker S. Five-year clinical and angiographic outcomes of a randomized comparison of sirolimus-eluting and paclitaxel-eluting stents: results of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization LATE trial. Circulation. 2011 Jun 21;123(24):2819-28, 6 p following 2828. doi: 10.1161/CIRCULATIONAHA.110.004762. Epub 2011 Jun 6.
Results Reference
derived
PubMed Identifier
20298923
Citation
Raber L, Juni P, Loffel L, Wandel S, Cook S, Wenaweser P, Togni M, Vogel R, Seiler C, Eberli F, Luscher T, Meier B, Windecker S. Impact of stent overlap on angiographic and long-term clinical outcome in patients undergoing drug-eluting stent implantation. J Am Coll Cardiol. 2010 Mar 23;55(12):1178-1188. doi: 10.1016/j.jacc.2009.11.052.
Results Reference
derived
PubMed Identifier
18272504
Citation
Billinger M, Beutler J, Taghetchian KR, Remondino A, Wenaweser P, Cook S, Togni M, Seiler C, Stettler C, Eberli FR, Luscher TF, Wandel S, Juni P, Meier B, Windecker S. Two-year clinical outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents in diabetic patients. Eur Heart J. 2008 Mar;29(6):718-25. doi: 10.1093/eurheartj/ehn021. Epub 2008 Feb 12.
Results Reference
derived
PubMed Identifier
17868802
Citation
Togni M, Eber S, Widmer J, Billinger M, Wenaweser P, Cook S, Vogel R, Seiler C, Eberli FR, Maier W, Corti R, Roffi M, Luscher TF, Garachemani A, Hess OM, Wandel S, Meier B, Juni P, Windecker S. Impact of vessel size on outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents: a subgroup analysis of the SIRTAX trial. J Am Coll Cardiol. 2007 Sep 18;50(12):1123-31. doi: 10.1016/j.jacc.2007.06.015. Epub 2007 Sep 4.
Results Reference
derived
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Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization
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