Sirolimus- and Paclitaxel-Eluting Stents for Small Vessels (ISAR-SMART-3)

This study has been completed.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00146575
First received: September 6, 2005
Last updated: January 10, 2008
Last verified: January 2008
  Purpose

The purpose of this study is to compare the efficacy of paclitaxel- and sirolimus-eluting stents to prevent re-blockage of small coronary arteries


Condition Intervention Phase
Coronary Disease
Device: Sirolimus-eluting stent (Cypher)
Device: Paclitaxel-eluting stent (Taxus)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Paclitaxel-Eluting Stent and Sirolimus-Eluting Stent for Restenosis Reduction in Small Coronary Vessels (ISAR-SMART-3)

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Late luminal loss [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Binary angiographic restenosis [ Time Frame: 1 year ]
  • Target lesion revascularization [ Time Frame: 1 year ]

Enrollment: 360
Study Start Date: June 2003
Study Completion Date: February 2005
Arms Assigned Interventions
Experimental: 1
randomized patients get sirolimus stent
Device: Sirolimus-eluting stent (Cypher)
patients have been implanted a Cypher stent
Other Name: Cypher
Experimental: 2
randomized patients get paclitaxel stent
Device: Paclitaxel-eluting stent (Taxus)
patients have been implanted a Taxus stent
Other Name: Taxus

Detailed Description:

Although use of bare metal stents has reduced restenosis in coronary vessels with a diameter ≥3 mm when compared to plain balloon angioplasty, most of the dedicated randomized studies have failed to show a beneficial effect of stent over balloon angioplasty in vessels with a small reference diameter. In spite of refinements in stent design and periprocedural therapy, the risk of restenosis after bare metal stenting in this setting remains elevated. Nowadays, percutaneous coronary interventions in small vessels account for 35-67% of interventional procedures performed in patients with coronary artery disease and, when bare metal stents are used, restenosis will be detected in more than 35% of the treated patients and a repeat revascularization procedure will be needed in more than 20% them. Several randomized trials have shown that stents eluting antiproliferative drugs, with sirolimus- and paclitaxel-eluting stents the only devices approved for commercial use so far, are highly effective in reducing restenosis when compared with bare metal stents. Subgroup analysis from these trials have shown that the efficacy of either sirolimus stent or paclitaxel stent extends also to those patients who undergo coronary stenting in small sized vessels. In addition, three randomized studies of sirolimus-eluting stents and bare metal stents used in coronary arteries smaller than 3 mm have reported 82-96% reduction in the relative risk of restenosis with the sirolimus stents thus, providing convincing evidence on the role of drug-eluting stents as an effective treatment strategy for coronary arteries with a small reference diameter.

At present, there is no direct evidence on the relative efficacy in the prevention of restenosis of sirolimus stent and paclitaxel stent after implantation in small coronary vessels. Selecting the most effective device for this particularly high-risk category that accounts for a large proportion of percutaneous coronary interventions, may have important clinical and economic implications. Comparisons of data from subgroup analysis of different trials have suggested that there might be differences in the efficacy to prevent restenosis between sirolimus and paclitaxel stents. However, indirect comparisons are subject to many limitations and consequently, conclusions based on their results may be erroneous. Therefore, reliable guidance on the selection of the most effective drug-eluting stent for treatment of lesions in coronary vessels with a small reference diameter could be provided only from a head-to-head comparison between these devices.

Comparison:

Sirolimus-eluting stent and paclitaxel-eluting stent in patients undergoing stenting in small coronary vessels.

  Eligibility

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

Inclusion Criteria:

  • Stable or unstable angina pectoris and/or a positive stress test
  • "de novo" lesion in small coronary arteries (vessel size <2.8 mm by visual estimation)
  • Written informed consent

Exclusion Criteria:

  • Diabetes mellitus
  • Myocardial infarction within 48 h. before enrollment
  • Target lesion located in the left main trunk or bypass graft
  • Contraindication or known allergy to aspirin, thienopyridines, rapamycin, paclitaxel or stainless steel
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146575

Locations
Germany
Deutsches Herzzentrum
Munich, Germany, 80636
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Albert Schomig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00146575     History of Changes
Other Study ID Numbers: GE IDE No. S01703
Study First Received: September 6, 2005
Last Updated: January 10, 2008
Health Authority: Germany: German Institute of Medical Documentation and Information

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

ClinicalTrials.gov processed this record on October 20, 2014