Spot Drug-Eluting Stenting for Long Coronary Stenoses

Not Applicable

Completed

• Conditions: Angioplasty
• Interventions: Device: Drug-eluting stents (Cypher and Taxus)

• Registration Number: NCT00738556
• Lead Sponsor: Cardiovascular Research Society, Greece

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-28
• Last Update Posted: 2009-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Drug-eluting stents (Cypher and Taxus)	Full cover stenting of coronary lesions
2	Drug-eluting stents (Cypher and Taxus)	Spot-stenting of significantly stenotic parts of a coronary lesion

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	3 years

Trial Locations

Locations (1)

Athens Euroclinic; 🇬🇷 Athens, Greece