The HYCORE1 Trial: Hybrid Revascularization Versus Coronary Artery Bypass Grafting

Sponsor
Rigshospitalet, Denmark
Study ID
NCT05504031
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Hybrid coronary revascularization — PROCEDURE
    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 — PROCEDURE
    Conventional revascularization with CABG of all significant stenoses through a sternotomy

Study Details

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.

Key Dates

First listed
Aug 17, 2022
Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2044

Study Design

Enrollment
1,048 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hybrid Group
    Complete revascularisation through a combined MIDCAB (LIMA-LAD graft trough a minimal invasive left anterior thoracotomy) and PCI (of all non-LAD stenoses)
  • Active Comparator: CABG Group
    Conventional CABG through a sternotomy

Primary Outcome Measure

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

Central Contacts

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