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.
Study Type
OBSERVATIONAL
Enrollment
201
retrieve long term follow up data on clinical outcome of study population, no intervention
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Baden Würtemberg, Germany
Klinikum der Ludwig-Maximilians Universität München
München, Bavaria, Germany
München Klinik Neuperlach
München, Bavaria, Germany
Heart Center Leipzig at University of Leipzig
Leipzig, Saxony, Germany
All-cause death
further categorized into cardiovascular, noncardiovascular, and undetermined deaths
Time frame: approximately 15 years after procedure
composite secondary endpoint
all-cause death, myocardial infarction or repeat target vessel revascularization
Time frame: approximately 15 years after procedure
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