Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Stenosis
- Sponsor
- Heart Center Leipzig - University Hospital
- Enrollment
- 201
- Locations
- 4
- Primary Endpoint
- All-cause death
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a long-term follow-up of a completed clinical trial which compared percutaneous coronary intervention (PCI) using sirolimus-eluting stents and coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease.
The purpose of the study is to obtain retrospective long-term data on clinical outcome of the study population.
Detailed Description
The randomized multicenter, open-label trial "Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis" was conducted at 4 tertiary care centers in Germany. 201 patients with unprotected left main stem stenosis (≥50%) with or without additional multivessel coronary artery disease were enrolled in a 1:1 ratio from July 2003 through February 2009. Results were published: https://pubmed.ncbi.nlm.nih.gov/21272743/ Long-term follow-up will be performed by a structured telephone interview using a standardized questionnaire by an interviewer blinded to treatment allocation. Wherever possible, data will be completed and verified by health care records. Retrospective data of the underlying randomized study will be included in data analysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •alive participants of underlying study who give their consent to participate
- •deceased participants of underlying study
Exclusion Criteria
- •alive participants of underlying study who do not consent
Outcomes
Primary Outcomes
All-cause death
Time Frame: approximately 15 years after procedure
further categorized into cardiovascular, noncardiovascular, and undetermined deaths
Secondary Outcomes
- composite secondary endpoint(approximately 15 years after procedure)