Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis

Phase 2

• Conditions: Coronary Stenosis; Coronary Artery Disease

• Registration Number: NCT00176397
• Lead Sponsor: University of Leipzig

Brief Summary

Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES).

The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis.

Detailed Description

Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES).

The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis.

The study was planned as a "non-inferiority" trial based on the hypothesis that PCI may be able to reach similar long-term results as compared to CABG.

Study Timeline

• Study Start: 2003-08
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Last Update Submitted: 2007-09-06
• Last Update Posted: 2007-09-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Significant left main coronary stenosis >= 50%

Exclusion Criteria

• Acute myocardial infarction (STEMI < 48h)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Major adverse coronary events (cardiac death, myocardial infarction, need for repeat revascularisation)

Secondary Outcome Measures

Name	Time	Method
Functional status (CCS-class)

Trial Locations

Locations (1)

University of Leipzig, Heart Center; 🇩🇪 Leipzig, Saxony, Germany