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

Coronary Disease Clinical Trial

Official title:

Randomized Trial of Paclitaxel-Eluting Stent and Sirolimus-Eluting Stent for Restenosis Reduction in Small Coronary Vessels (ISAR-SMART-3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146575
• Other study ID #: GE IDE No. S01703
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: January 10, 2008
• Start date: June 2003
• Est. completion date: February 2005

Study information

• Verified date: January 2008
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Sirolimus-eluting stent (Cypher)
patients have been implanted a Cypher stent
• Paclitaxel-eluting stent (Taxus)
patients have been implanted a Taxus stent

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum	Munich
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Kastrati A, Dibra A, Eberle S, Mehilli J, Suárez de Lezo J, Goy JJ, Ulm K, Schömig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA. 2005 Aug 17;294(7):819-25. — View Citation

Mehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schömig A; Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries (ISAR-SMART 3) Study Investigators. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coron — View Citation

Morice MC. Stenting for small coronary vessels. J Invasive Cardiol. 2003 Jul;15(7):377-9. Review. — View Citation

Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. — View Citation

Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late luminal loss		6 months
Secondary	Binary angiographic restenosis		1 year
Secondary	Target lesion revascularization		1 year