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NCT Number: NCT07269366

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, Netherlands

Location status: Recruiting

Location contact

Erik Lipsic, Dr.

CONTACT

[email protected]

+31503612355

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CABG

Procedure

CABG (coronary artery bypass grafting)

PCI

Procedure

PCI (percutaneous coronary intervention)

Primary outcomes

  1. Hierarchical composite of all-cause mortality, major adverse cardiovascular events, and heart failure hospitalizations

    Time frame: 4 years

    Outcomes will be analyzed using a hierarchical (win ratio / Finkelstein-Schoenfeld) approach to account for clinical severity

Secondary outcomes

  1. Individual components of the primary endpoint

    Time frame: 4 years

    Analysis of each component of the primary endpoint separately - all-cause mortality, non-procedural myocardial infarction, stroke, unplanned revascularization, and heart failure hospitalizations.

  2. Cardiovascular mortality

    Time frame: 4 years

    Death due to cardiovascular causes

  3. Periprocedural myocardial infarction

    Time frame: Within 30 days post-procedure

    Myocardial infarction occurring during or within 30 days after the index revascularization procedure.

  4. Target vessel and target lesion revascularization

    Time frame: 4 years

    Any repeat revascularization of the initially treated coronary vessel or lesion.

  5. Change in quality of life - Kansas City Cardiomyopathy Questionnaire

    Time frame: at 1 and 4 years (compared to baseline)

    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.

  6. Changes in quality of life - Seattle Angina Questionnaire

    Time frame: at 1 and 4 years (compared to baseline)

    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.

  7. Cost-effectiveness

    Time frame: 4 years

    Cost-effectiveness analysis comparing CABG and PCI, expressed as quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER).

Study contacts

Contact information is provided by the study sponsor or research team.

Erik Lipsic, Dr

CONTACT

[email protected]

+31 50 3612355

Ruben R. De With, Dr

CONTACT

[email protected]

+31 50 3612355

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Dutch Heart Foundation

Registry information

Official study title

Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function

Acronym: STICH 3*0-NL

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Dec 8, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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