NCT07269366

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
358

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
94mo left

Started Feb 2026

Longer than P75 for not_applicable coronary-artery-disease

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Feb 2026Feb 2034

First Submitted

Initial submission to the registry

November 20, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2034

Last Updated

December 8, 2025

Status Verified

October 1, 2025

Enrollment Period

8 years

First QC Date

November 20, 2025

Last Update Submit

December 5, 2025

Conditions

Coronary Artery DiseaseCoronary Artery Disease (CAD)Multivessel Coronary Artery DiseaseCABGCABG in Low EFHeart FailurePCIRevascularization

Keywords

coronary arterycoronary artery diseaseheart failurelow ejection fractionhfrefcabgcoronary artery bypass graftpcirevascularization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Individual components of the primary endpoint

    4 years

  • Cardiovascular mortality

    4 years

  • Periprocedural myocardial infarction

    Within 30 days post-procedure

  • Target vessel and target lesion revascularization

    4 years

  • Change in quality of life - Kansas City Cardiomyopathy Questionnaire

    at 1 and 4 years (compared to baseline)

  • +2 more secondary outcomes

Study Arms (2)

CABG (surgery)

EXPERIMENTAL

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

Procedure: CABG

PCI (percutaneous)

OTHER

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

Procedure: PCI

Interventions

CABGPROCEDURE

CABG (coronary artery bypass grafting)

CABG (surgery)
PCIPROCEDURE

PCI (percutaneous coronary intervention)

PCI (percutaneous)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseHeart Failure

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Erik Lipsic, Dr

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik Lipsic, Dr

CONTACT

+31 50 3612355e.lipsic@umcg.nl

Ruben R. De With, Dr

CONTACT

+31 50 3612355r.r.de.with@umcg.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 8, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2034

Study Completion (Estimated)

February 1, 2034

Last Updated

December 8, 2025

Record last verified: 2025-10