Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease

Conditions
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Coronary Stenosis, Coronary Artery Disease

Intervention / Treatment
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* Other: percutaneous coronary intervention vs bypass graft surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| percutaneous coronary intervention (PCI)<br>percutaneous coronary intervention (PCI) with sirolimus-eluting stents | Other: percutaneous coronary intervention vs bypass graft surgery<br>* retrieve long term follow up data on clinical outcome of study population, no intervention<br>|
| coronary artery bypass grafting (CABG)<br>coronary artery bypass graft surgery | Other: percutaneous coronary intervention vs bypass graft surgery<br>* retrieve long term follow up data on clinical outcome of study population, no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | further categorized into cardiovascular, noncardiovascular, and undetermined deaths | approximately 15 years after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite secondary endpoint | all-cause death, myocardial infarction or repeat target vessel revascularization | approximately 15 years after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, sirolimus-eluting stent, coronary artery bypass grafting