Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL) (STICH 3*0-NL)

Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Heart Failure; CABG; PCI; Coronary Artery Disease (CAD); Multivessel Coronary Artery Disease; Revascularization; CABG in Low EF
• Intervention / Treatment: Procedure: CABG; Procedure: PCI

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.

• Study Type: Interventional
• Enrollment (Estimated): 358
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erik Lipsic, Dr; Phone Number: +31 50 3612355; Email: e.lipsic@umcg.nl
• Study Contact Backup: Name: Ruben R. De With, Dr; Phone Number: +31 50 3612355; Email: r.r.de.with@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Recruiting
    • University Medical Center Groningen
    • Contact: Erik Lipsic, Dr.; Phone Number: +31503612355; Email: e.lipsic@umcg.nl

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CABG (surgery); Patients randomized to CABG will receive CABG - aiming for full revascularization	Procedure: CABG; CABG (coronary artery bypass grafting)
Other: PCI (percutaneous); Patients randomized to PCI will receive PCI - aiming for full revascularization	Procedure: PCI; PCI (percutaneous coronary intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hierarchical composite of all-cause mortality, major adverse cardiovascular events, and heart failure hospitalizations	Outcomes will be analyzed using a hierarchical (win ratio / Finkelstein-Schoenfeld) approach to account for clinical severity	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual components of the primary endpoint	Analysis of each component of the primary endpoint separately - all-cause mortality, non-procedural myocardial infarction, stroke, unplanned revascularization, and heart failure hospitalizations.	4 years
Cardiovascular mortality	Death due to cardiovascular causes	4 years
Periprocedural myocardial infarction	Myocardial infarction occurring during or within 30 days after the index revascularization procedure.	Within 30 days post-procedure
Target vessel and target lesion revascularization	Any repeat revascularization of the initially treated coronary vessel or lesion.	4 years
Change in quality of life - Kansas City Cardiomyopathy Questionnaire	Change in patient-reported quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is scored 0-100 per domain, with higher scores indicating better health status. A positive change from baseline reflects improvement. A ≥5-point change is considered clinically meaningful.	at 1 and 4 years (compared to baseline)
Changes in quality of life - Seattle Angina Questionnaire	Change in patient-reported quality of life assessed using the Seattle Angina Questionnaire (SAQ). The SAQ is scored in 5 domains from 0-100 per domain, with higher scores indicating fewer symptoms and better health status. A change of ≥5 points is generally considered clinically meaningful.	at 1 and 4 years (compared to baseline)
Cost-effectiveness	Cost-effectiveness analysis comparing CABG and PCI, expressed as quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER).	4 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Dutch Heart Foundation
• Investigators: Principal Investigator: Erik Lipsic, Dr, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2034
• Study Completion (Estimated): May 1, 2034

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: coronary artery disease; heart failure; coronary artery bypass graft; coronary artery; revascularization; pci; cabg; hfref; low ejection fraction
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Heart Failure; Coronary Artery Disease
• Other Study ID Numbers: NL-009839; 01-001-2024-0545 (Other Grant/Funding Number: Dutch Heart Foundation (Hartstichting))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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