Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization

This study has been completed.
University of Zurich
Information provided by:
University of Bern Identifier:
First received: February 22, 2006
Last updated: October 19, 2006
Last verified: February 2006

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.

Condition Intervention Phase
Coronary Heart Disease
Device: Sirolimus-eluting stent
Device: Paclitaxel-eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization: SIRTAX Trial

Resource links provided by NLM:

Further study details as provided by University of Bern:

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

Estimated Enrollment: 1012
Study Start Date: April 2003
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Please refer to this study by its identifier: NCT00297661

University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
University of Zurich
Principal Investigator: Stephan Windecker, MD Department of Cardiology, University Hospital Bern
Study Director: Peter Juni, MD Department of Social and Preventive Medicine, University of Bern
Study Chair: Bernhard Meier, MD Department of Cardiology, University Hospital Bern
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00297661     History of Changes
Other Study ID Numbers: KEK-33/2003
Study First Received: February 22, 2006
Last Updated: October 19, 2006
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Bern:
Coronary Revascularization
Sirolimus-eluting stents
Paclitaxel-eluting stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic processed this record on April 17, 2014