Spot Drug-Eluting Stenting for Long Coronary Stenoses

NCT ID: NCT00738556

Last Updated: 2009-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2007-09-30

Brief Summary

Most doctors who use the new drug-eluting stents for the treatment of long coronary narrowings tend to cover the full length of the lesion with long or multiple stents. The investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very tight parts of the coronary narrowing, might result in better outcomes by means of avoiding multiple stents that have been associated with significant complications such as late stent thrombosis.

Detailed Description

Coronary artery lesion length is an independent predictor of restenosis following coronary intervention and the deployment of multiple or long bare metal stents has been associated with an increased risk of adverse clinical outcome. Spot stenting, ie discrete stenting of only the most severe stenoses of long, diffuse lesions has been proposed as an alternative in this clinical setting. The introduction of drug-eluting stents has resulted in longer lesions being stented and the use of multiple, overlapping DES in patients with diffusely diseased coronary arteries has been considered safe and effective. However, there has also been evidence of increased major adverse cardiac events (MACE) with the use of multiple, overlapping DES,10-12 while long DES have been associated with increased probability of intraprocedural stent thrombosis.13 We hypothesized that an approach based on spot-stenting with the use of DES might result in superior clinical outcomes compared to full cover of atheromatic lesions with long or multiple stents. We are therefore conducting a randomized comparison of spot versus multiple overlapping stenting on consecutive patients with long (>20 mm) lesions and indications for percutaneous coronary intervention.

Conditions

Angioplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Full cover stenting of coronary lesions

Group Type: ACTIVE_COMPARATOR

Drug-eluting stents (Cypher and Taxus)

Intervention Type: DEVICE

Spot or full length stenting of a coronary lesion

2

Spot-stenting of significantly stenotic parts of a coronary lesion

Group Type: ACTIVE_COMPARATOR

Drug-eluting stents (Cypher and Taxus)

Intervention Type: DEVICE

Spot or full length stenting of a coronary lesion

Interventions

Drug-eluting stents (Cypher and Taxus)

Spot or full length stenting of a coronary lesion

Intervention Type: DEVICE

Other Intervention Names

Sirolimus-eluting stents (Cypher, J&J); Paclitaxel-eluting stents (Taxus, Boston Scientific)

Eligibility Criteria

Inclusion Criteria

• Consenting, consecutive patients with a de novo, native coronary artery lesion longer than 20 mm.

Exclusion Criteria

• Unprotected left main coronary artery stenosis,
• Left ventricular ejection fraction <25%, OR
• Contraindication to aspirin or clopidogrel

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiovascular Research Society, Greece

OTHER

Sponsor Role: lead

Responsible Party

Athens Euroclinic

Principal Investigators

Demosthenes Katritsis, MD, PhD

Role: STUDY_CHAIR

Athens Euroclinic and Cardiovasdcular Research Society

Locations

Athens Euroclinic

Athens, Attica, Greece

Athens Euroclinic

Athens, , Greece

Countries

Greece

References

Katritsis DG, Korovesis S, Karabinos I, Giazitzoglou E, Theodorou S, Karvouni E, Voridis E. Sirolimus-versus paclitaxel-eluting stents: a comparison of two consecutive series in routine clinical practice. J Interv Cardiol. 2006 Feb;19(1):31-7. doi: 10.1111/j.1540-8183.2006.00101.x.

Reference Type: BACKGROUND

PMID: 16483337 (View on PubMed)

Katritsis DG, Korovesis S, Karvouni E, Giazitzoglou E, Theodorou S, Kourlaba G, Panagiotakos D, Voridis E. Direct versus predilatation drug-eluting stenting: a randomized clinical trial. J Invasive Cardiol. 2006 Oct;18(10):475-9.

Reference Type: BACKGROUND

PMID: 17235419 (View on PubMed)

Karvouni E, Korovesis S, Katritsis DG. Very late thrombosis after implantation of sirolimus eluting stent. Heart. 2005 Jun;91(6):e45. doi: 10.1136/hrt.2004.056341.

Reference Type: BACKGROUND

PMID: 15894746 (View on PubMed)

Katritsis DG, Karvouni E, Ioannidis JP. Meta-analysis comparing drug-eluting stents with bare metal stents. Am J Cardiol. 2005 Mar 1;95(5):640-3. doi: 10.1016/j.amjcard.2004.10.041.

Reference Type: BACKGROUND

PMID: 15721109 (View on PubMed)

Other Identifiers

2.15.8.08

Identifier Type: -

Identifier Source: org_study_id