Clinical trial NCT05963620: Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery
Official title: Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Coronary Stenosis
Coronary Artery Disease
Keywords: Percutaneous coronary intervention
sirolimus-eluting stent
coronary artery bypass grafting
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause death
timeFrame: approximately 15 years after procedure
Secondary outcomes:
measure: composite secondary endpoint
timeFrame: approximately 15 years after procedure
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen
state: Baden Würtemberg
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians Universität München
state: Bayern
city: München
country: Germany
facility: München Klinik Neuperlach
state: Bayern
city: Leipzig
country: Germany
facility: Heart Center Leipzig at University of Leipzig
state: Saxony
Study officials:
affiliation: Heart Center Leipzig at University of Leipzig
name: Steffen Desch, MD
role: STUDY_CHAIR
References: