Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| percutaneous coronary intervention (PCI) percutaneous coronary intervention (PCI) with sirolimus-eluting stents |
Other: percutaneous coronary intervention vs bypass graft surgery
retrieve long term follow up data on clinical outcome of study population, no intervention
|
| coronary artery bypass grafting (CABG) coronary artery bypass graft surgery |
Other: percutaneous coronary intervention vs bypass graft surgery
retrieve long term follow up data on clinical outcome of study population, no intervention
|
Outcome Measures
Primary Outcome Measures
- All-cause death [approximately 15 years after procedure]
further categorized into cardiovascular, noncardiovascular, and undetermined deaths
Secondary Outcome Measures
- composite secondary endpoint [approximately 15 years after procedure]
all-cause death, myocardial infarction or repeat target vessel revascularization
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitäts-Herzzentrum Freiburg Bad Krozingen | Bad Krozingen | Baden Würtemberg | Germany | 79189 |
| 2 | Klinikum der Ludwig-Maximilians Universität München | München | Bayern | Germany | 80336 |
| 3 | München Klinik Neuperlach | München | Bayern | Germany | 81737 |
| 4 | Heart Center Leipzig at University of Leipzig | Leipzig | Saxony | Germany | 04289 |
Sponsors and Collaborators
- Heart Center Leipzig - University Hospital
Investigators
- Study Chair: Steffen Desch, MD, Heart Center Leipzig at University of Leipzig
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-0444