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

Heart Center Leipzig - University Hospital

Status: Invitation-only

Conditions: Coronary Artery Disease; Coronary Stenosis

Treatments: Other: percutaneous coronary intervention vs bypass graft surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05963620

2021-0444

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

201 participants in 2 patient groups

percutaneous coronary intervention (PCI)

Description:

percutaneous coronary intervention (PCI) with sirolimus-eluting stents

Treatment:

Other: percutaneous coronary intervention vs bypass graft surgery

coronary artery bypass grafting (CABG)

Description:

coronary artery bypass graft surgery

Treatment:

Other: percutaneous coronary intervention vs bypass graft surgery