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

Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Artery Disease; Coronary Stenosis
• Intervention / Treatment: Other: percutaneous coronary intervention vs bypass graft surgery

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 Type: Observational
• Enrollment (Estimated): 201

Contacts and Locations

Study Locations

• Germany
  • Baden Würtemberg
    • Bad Krozingen, Baden Würtemberg, Germany, 79189
      • Universitäts-Herzzentrum Freiburg Bad Krozingen
  • Bayern
    • München, Bayern, Germany, 80336
      • Klinikum der Ludwig-Maximilians Universität München
    • München, Bayern, Germany, 81737
      • München Klinik Neuperlach
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Heart Center Leipzig at University of Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
percutaneous coronary intervention (PCI); percutaneous coronary intervention (PCI) with sirolimus-eluting stents	Other: percutaneous coronary intervention vs bypass graft surgery; retrieve long term follow up data on clinical outcome of study population, no intervention
coronary artery bypass grafting (CABG); coronary artery bypass graft surgery	Other: percutaneous coronary intervention vs bypass graft surgery; retrieve long term follow up data on clinical outcome of study population, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	further categorized into cardiovascular, noncardiovascular, and undetermined deaths	approximately 15 years after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite secondary endpoint	all-cause death, myocardial infarction or repeat target vessel revascularization	approximately 15 years after procedure

Collaborators and Investigators

• Sponsor: Heart Center Leipzig - University Hospital
• Investigators: Study Chair: Steffen Desch, MD, Heart Center Leipzig at University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; coronary artery bypass grafting; sirolimus-eluting stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: 2021-0444

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No