Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL)

NCT ID: NCT07269366

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2034-02-28

Brief Summary

This randomized multicenter trial compares coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in 358 patients with ischemic left ventricular dysfunction and multivessel coronary disease. The study evaluates differences in survival, major cardiovascular events, and quality of life over 4 years, and contributes to the international STICH 3.0 collaboration assessing long-term outcomes.

Detailed Description

Patients with ischemic left ventricular systolic dysfunction (iLVSD) and multivessel coronary artery disease (CAD) have a poor prognosis. Coronary artery bypass grafting (CABG) has been shown to improve long-term survival in this population compared to medical therapy alone. However, CABG carries higher short-term risks, leading to underutilization in older and comorbid patients. In contrast, percutaneous coronary intervention (PCI) is frequently performed due to perceived lower procedural risk, despite limited evidence supporting its benefit in patients with LV dysfunction. Previous studies comparing PCI with medical therapy excluded patients with clear indications for revascularization, such as those with significant angina or recent acute coronary syndrome, leaving uncertainty about the optimal treatment strategy.

The STICH 3.0-NL trial is a prospective, randomized, controlled, open-label, multicenter study designed to compare CABG and PCI in patients with iLVSD (LVEF <40%) and multivessel CAD who are candidates for coronary revascularization. A total of 358 patients will be enrolled and randomized in a 1:1 ratio to undergo CABG or PCI, aiming for full revascularization.

The primary endpoint is a hierarchical composite of all-cause mortality, recurrent major adverse cardiovascular events (MACE: non-procedural myocardial infarction, stroke, or unplanned revascularization), and recurrent hospitalizations for heart failure at 4 years. Secondary endpoints include the individual components of the primary endpoint, cardiovascular mortality, periprocedural myocardial infarction, target vessel and lesion revascularization, changes in quality of life (Seattle Angina Questionnaire and KCCQ), and cost-effectiveness expressed as QALY and ICER.

The STICH 3.0-NL trial will contribute approximately 10% of the total cohort to the international STICH 3.0 collaboration, enabling long-term analyses of all-cause mortality at 5 and 10 years and providing critical evidence to guide revascularization strategies in patients with ischemic cardiomyopathy.

Conditions

Coronary Artery Disease; Coronary Artery Disease (CAD); Multivessel Coronary Artery Disease; CABG; CABG in Low EF; Heart Failure; PCI; Revascularization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CABG (surgery)

Patients randomized to CABG will receive CABG - aiming for full revascularization

Group Type: EXPERIMENTAL

CABG

Intervention Type: PROCEDURE

CABG (coronary artery bypass grafting)

PCI (percutaneous)

Patients randomized to PCI will receive PCI - aiming for full revascularization

Group Type: OTHER

PCI

Intervention Type: PROCEDURE

PCI (percutaneous coronary intervention)

Interventions

CABG

CABG (coronary artery bypass grafting)

Intervention Type: PROCEDURE

PCI

PCI (percutaneous coronary intervention)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• LVEF≤ 40%
• Angina pectoris, CCS≥2 and/or hospitalization for ACS or heart failure within 1 year prior to randomization
• Multivessel CAD (2-3 vessel-disease with coronary lesions >70% and involvement of proximal LAD, and/or LM stenosis of >50%). Target vessels are determined by the local Heart Time
• Clinical and angiographical characteristics suitable for isolated coronary revascularization both by CABG or PCI according to the judgment of the local Heart Team
• Written informed consent

Exclusion Criteria

• ACS < 48 hours before randomization
• Valvular/structural heart disease requiring intervention
• Contra-indications to DAPT
• Non-cardiac condition with life expectancy < 1 year
• Previous CABG
• Decompensated HF at the time of inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Heart Foundation

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Lipsic, Dr

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Central Contacts

Erik Lipsic, Dr

Role: CONTACT

e.lipsic@umcg.nl

+31 50 3612355

Ruben R. De With, Dr

Role: CONTACT

r.r.de.with@umcg.nl

+31 50 3612355

Other Identifiers

01-001-2024-0545

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL-009839

Identifier Type: -

Identifier Source: org_study_id