Bypass surgery versus stents for people with weak heart pumping and blockages in multiple coronary arteries
Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function
This trial tests whether bypass surgery (CABG) or stents (PCI) lead to better survival, fewer major heart problems, and improved quality of life for adults with reduced left ventricular function (LVEF ≤40%) and multivessel coronary disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 358 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT07269366 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, open-label, multicenter trial enrolling 358 adults with ischemic left ventricular systolic dysfunction (LVEF ≤40%) and multivessel coronary artery disease. Participants are randomized 1:1 to undergo coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) with the aim of full revascularization. The primary endpoint is a hierarchical composite of all-cause mortality, recurrent major adverse cardiovascular events (non-procedural MI, stroke, unplanned revascularization), and recurrent heart failure hospitalizations over 4 years. Secondary outcomes include the individual components of the composite and quality-of-life measures, and the results will contribute to the international STICH 3.0 collaboration.
Who should consider this trial
Good fit: Adults (≥18 years) with ischemic LV systolic dysfunction (LVEF ≤40%), multivessel CAD, and recent angina or hospitalization for ACS or heart failure who are judged suitable for either CABG or PCI by the local Heart Team are ideal candidates.
Not a fit: Patients with ACS within 48 hours, prior CABG, valvular disease requiring intervention, contraindications to dual antiplatelet therapy, decompensated heart failure at enrollment, or noncardiac conditions with life expectancy under one year are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the trial could show which revascularization approach gives better long-term survival, fewer major cardiac events, and improved quality of life for patients with low ejection fraction.
How similar studies have performed: Previous STICH trials showed CABG improves long-term survival compared with medical therapy in this population, but randomized comparisons between modern CABG and PCI for patients with low LVEF are limited, so this trial addresses a key evidence gap.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Erik Lipsic, Dr — University Medical Center Groningen
- Study coordinator: Erik Lipsic, Dr
- Email: e.lipsic@umcg.nl
- Phone: +31 50 3612355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.