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

• Conditions: Coronary Stenosis; Coronary Artery Disease
• Interventions: Other: percutaneous coronary intervention vs bypass graft surgery

• Registration Number: NCT05963620
• Lead Sponsor: Heart Center Leipzig - University Hospital

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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-19
• Last Update Submitted: 2023-07-19
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
percutaneous coronary intervention (PCI)	percutaneous coronary intervention vs bypass graft surgery	percutaneous coronary intervention (PCI) with sirolimus-eluting stents
coronary artery bypass grafting (CABG)	percutaneous coronary intervention vs bypass graft surgery	coronary artery bypass graft surgery

Primary Outcome Measures

Name	Time	Method
All-cause death	approximately 15 years after procedure	further categorized into cardiovascular, noncardiovascular, and undetermined deaths

Secondary Outcome Measures

Name	Time	Method
composite secondary endpoint	approximately 15 years after procedure	all-cause death, myocardial infarction or repeat target vessel revascularization

Trial Locations

Locations (4)

München Klinik Neuperlach; 🇩🇪 München, Bayern, Germany

Heart Center Leipzig at University of Leipzig; 🇩🇪 Leipzig, Saxony, Germany

Universitäts-Herzzentrum Freiburg Bad Krozingen; 🇩🇪 Bad Krozingen, Baden Würtemberg, Germany

Klinikum der Ludwig-Maximilians Universität München; 🇩🇪 München, Bayern, Germany