NCT05329285

CABG or PCI in Patients With Ischemic Cardiomyopathy

CABG or PCI in Patients With Ischemic Cardiomyopathy - A Randomized Registry Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 470 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) \<40%) and multi-vessel coronary artery disease.

Detailed description

Short background/ Rationale/Aim: CABG has been shown to prolong survival in patients with reduced left ventricular (LV) function and multi-vessel coronary artery disease and "CABG is recommended as the first revascularization strategy choice in patients with multi-vessel disease and acceptable surgical risk". However, a major concern with CABG is the early risk of complications, including death and stroke. Although PCI has lower rates of peri-procedural complications than CABG in patients without heart failure (HF), this has not been confirmed in patients with HF. The lack of contemporary data comparing CABG and PCI in HF leaves clinicians with no guidance as to which option to choose, and a robust trial is therefore necessary. The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) \< 40%) and multi-vessel coronary artery disease. Study objective: To test whether PCI is non-inferior to CABG for revascularization of patients with ischemic heart failure. Study design: Multicentre, open-label, randomized controlled trial Study population: Patients with ischemic cardiomyopathy and reduced ejection fraction. Number of subjects: 470 subjects Investigational treatment: PCI Treatment in control group: CABG Study endpoints: Primary endpoint (variable): The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization at 3 years. Key secondary endpoint The hierarchical occurrence (in descending order of importance) at 3-year follow-up of time to death, time to stroke, time to non-procedural myocardial infarction, number of heart failure hospitalizations and 1-year Kansas City Cardiomyopathy Questionnaire (KCCQ) score; evaluated using the win ratio approach. Secondary safety endpoints In-hospital occurrence of the following: 1. Death 2. Stroke 3. Non-procedural myocardial infarction 4. The occurrence of in-hospital BARC ≥3 bleeding Time to the occurrence of the following: 5. Mediastinitis 6. Pericardial tamponade Other secondary endpoints 1\. Time to the occurrence of the following: A. Death, stroke or non-procedural myocardial infarction B. Death or heart failure hospitalization C. Heart failure hospitalization D. Coronary revascularization E. Death or myocardial infarction F. Death or stroke 2. Total number of days in-hospital during index hospitalization 3. Total number of days in intensive care unit during index hospitalization 4. Quality of life at 30 days and 365 days.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Coronary Intervention (PCI)	Alternative treatment

Timeline

• Start date: 2022-09-14
• Primary completion: 2028-12-31
• Completion: 2052-12-31
• First posted: 2022-04-15
• Last updated: 2024-06-24

Locations

1 site across 1 country: Sweden