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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| percutaneous coronary intervention (PCI) | percutaneous coronary intervention (PCI) with sirolimus-eluting stents |
| |
| coronary artery bypass grafting (CABG) | coronary artery bypass graft surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous coronary intervention vs bypass graft surgery | Other | retrieve long term follow up data on clinical outcome of study population, no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | further categorized into cardiovascular, noncardiovascular, and undetermined deaths | approximately 15 years after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| composite secondary endpoint | all-cause death, myocardial infarction or repeat target vessel revascularization | approximately 15 years after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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participants of the preceding study: Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis
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| Name | Affiliation | Role |
|---|---|---|
| Steffen Desch, MD | Heart Center Leipzig at University of Leipzig | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Herzzentrum Freiburg Bad Krozingen | Bad Krozingen | Baden Würtemberg | 79189 | Germany | ||
| Klinikum der Ludwig-Maximilians Universität München |
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| München |
| Bavaria |
| 80336 |
| Germany |
| München Klinik Neuperlach | München | Bavaria | 81737 | Germany |
| Heart Center Leipzig at University of Leipzig | Leipzig | Saxony | 04289 | Germany |
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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