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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

ACS < 48 hours before randomization

Valvular/structural heart disease requiring intervention

Contra-indications to DAPT

Non-cardiac condition with life expectancy < 1 year

Trial design

Design model

Parallel

Treatments tested in this trial

  • CABG

    Procedure/Surgery

    CABG (coronary artery bypass grafting)

  • PCI

    Procedure/Surgery

    PCI (percutaneous coronary intervention)

Treatment groups

358 Participants
are divided into 2 treatment groups
Group A: CABG (surgery)Experimental treatment 1 intervention
Group B: PCI (percutaneous)Other 1 intervention

Trial outcomes

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

Time frame
4 years

Secondary outcomes

1

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.

Time frame
4 years
2

Cardiovascular mortality

Death due to cardiovascular causes

Time frame
4 years
3

Periprocedural myocardial infarction

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

Time frame
Within 30 days post-procedure
4

Target vessel and target lesion revascularization

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

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

Dutch Heart Foundation

Collaborator