Spot Drug-Eluting Stenting for Long Coronary Stenoses

Angioplasty Clinical Trial

Official title:

Spot Drug-Eluting vs Full Cover Stenting for Long Coronary Stenoses: a Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738556
• Other study ID #: 2.15.8.08
• Status: Completed
• Phase: N/A
• First received: August 18, 2008
• Last updated: January 28, 2009
• Start date: January 2003
• Est. completion date: September 2007

Study information

• Verified date: January 2009
• Source: Cardiovascular Research Society, Greece
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty
• Coronary Stenosis

Intervention

Device:
• Drug-eluting stents (Cypher and Taxus)
Spot or full length stenting of a coronary lesion

Locations

Country	Name	City	State
Greece	Athens Euroclinic	Athens	Attica
Greece	Athens Euroclinic	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovascular Research Society, Greece

Country where clinical trial is conducted

Greece, 

References & Publications (4)

Karvouni E, Korovesis S, Katritsis DG. Very late thrombosis after implantation of sirolimus eluting stent. Heart. 2005 Jun;91(6):e45. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events		3 years	Yes