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Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization

NCT ID: NCT00297661

Last Updated: 2006-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1012 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Keywords

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Coronary Revascularization Sirolimus-eluting stents Paclitaxel-eluting stents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Sirolimus-eluting stent

Intervention Type DEVICE

Paclitaxel-eluting stent

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Principal Investigators

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Stephan Windecker, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, University Hospital Bern

Peter Juni, MD

Role: STUDY_DIRECTOR

Department of Social and Preventive Medicine, University of Bern

Bernhard Meier, MD

Role: STUDY_CHAIR

Department of Cardiology, University Hospital Bern

Locations

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University Hospital Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 16105989 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27578808 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26823484 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24531331 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22440496 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21951630 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21646500 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20298923 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18272504 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17868802 (View on PubMed)

Other Identifiers

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KEK-33/2003

Identifier Type: -

Identifier Source: org_study_id