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.
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.
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
Parallel
Hybrid coronary revascularization
Procedure/SurgeryCoronary 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/SurgeryConventional revascularization with CABG of all significant stenoses through a sternotomy
A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization
A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization
Angina symptoms
Angina symptoms measured using Seattle Angina Questionnaire
Health related quality of life
Health related quality of life using EQ-5D
Hospital free days
Hospital free days
Procedural complications
Procedural complications defined as periprocedural myocardial infarction, unplanned re-intervention, stroke, BARC 3-5 bleeding complications or sternal wound infection
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Rigshospitalet, Denmark
Lead sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
UMC Utrecht
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
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