The HYCORE1 Trial: Hybrid Revascularization Versus Coronary Artery Bypass Grafting

NCT05504031 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Copenhagen University Hospital, Rigshospitalet

Phase

Not applicable

Started

2026-07-15

Last updated

2026-06-03

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Hybrid coronary revascularizationConventional revascularization

Hybrid coronary revascularization: Coronary revascularization is conducted as a combined MIDCAB (LIMA-LAD grafting through a minimally invasive anterior left thoracotomy) and PCI (of all non-LAD stenoses)

Conventional revascularization: Conventional revascularization with CABG of all significant stenoses through a sternotomy

Study summary

Coronary artery disease often necessitates complex interventions like coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) with stents. Hybrid coronary revascularization, a minimally invasive approach, integrates both methods for complete revascularization. This multicenter randomized trial involves 1200 patients, comparing hybrid coronary revascularization to CABG in a 1:1 ratio. Eligible participants have multi-vessel coronary disease and are referred for elective or sub-acute CABG. Inclusion criteria include age 18 or older, significant multi-vessel disease, and potential complete revascularization with both methods. Exclusion criteria include chronic kidney disease, pregnancy, contradiction to dual antiplatelet therapy, recent myocardial infarction, and acute revascularization. The hybrid group undergoes staged revascularization, combining minimally invasive grafting of the left interior mammary artery to the left anterior descending artery with PCI-stenting of remaining lesions. The control group undergoes conventional CABG with sternotomy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, or unplanned hospitalization, while secondary outcomes include periprocedural complications, cardiovascular mortality, hospital-free days within 90 days, angina frequency, and quality of life. Evaluation occurs 12 months after randomization. The trial commences in 2024, with inclusion expected to conclude in 5 years.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Written informed consent * ≥ 18 years of age * Functionally significant MVD, defined as ≥ 70% diameter stenosis by visual estimation or functionally significant stenosis (FFR \< 0.80, non-hyperaemic index (iFR) \< 0.89) in at least two of the major epicardial vessels or major side branches * Patient history reviewed by both cardiac surgeon and cardiologist who in agreement find both CABG and hybrid revascularisation indicated and technically feasible with an expectation of complete revascularisation of all functionally significant stenoses in the LAD and at least one other coronary artery ≥ 2.5mm in diameter or left main bifurcation stenosis with functionally significant stenoses in both the LAD and left circumflex artery. Exclusion Criteria: * Chronic kidney disease with estimated glomerular filtration rate \< 20 mL/min/kg * Pregnancy * Left main stenosis without additional functionally significant stenoses in both the LAD and the LCX * Contraindications to the use of dual antiplatelet therapy * STEMI within 1 month * Indication for acute revascularization

Primary outcome measure(s)

A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization — 12 months after randomization
A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization

Trial sites (3)

Facility	City	Region
UZ Leuven	Leuven	Belgium
Rigshospitalet	Copenhagen	Capital Region
UMC Utrecht	Utrecht	Netherlands

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05504031 on ClinicalTrials.gov ↗ ← All trials in the Netherlands