The MICRA-HYBRID trial is a prospective, multicenter, randomized controlled study comparing multivessel hybrid coronary revascularization (HCR) as minimally invasive arterial bypass grafting to left-sided coronary targets (LAD and LCx) plus PCI of the RCA versus conventional off-pump coronary artery bypass grafting (OPCAB) via median sternotomy in patients with three-vessel coronary artery disease. The primary goal is to evaluate whether multivessel-HCR provides superior 30-day "textbook" clinical outcomes (mortality, MI, stroke, re-exploration for bleeding, and other complications) while improving perioperative recovery and long-term cardiovascular outcomes.
Patients with three-vessel disease (either angiographic stenoses >70% or a fractional flow reserve value ≤0.80)
Left main diameter stenosis ≥50% or a left main intravascular ultrasound minimal luminal area of ≤4.5 mm2 or fractional flow reserve value ≤0.80 combined with significant CAD of the right coronary artery
Age < 18 or > 85 years
Chronic total occlusion of the RCA
In-stent RCA restenosis
RCA stenosis with high-risk clinical features requiring urgent PCI or surgical revasculari-zation.
Parallel
Multivessel Hybrid Coronary Revascularization
Procedure/SurgeryMultivessel-HCR consists of MICS revascularization of the left sided coronary vessels (LAD , Cx) combined with PCI for the RCA during the same admission or within 4 weeks postoperatively. Surgical revascularization is performed through MICS which consists of either robotically or non-robotically assisted thoracoscopic IMA harvesting followed by total arterial off-pump anastomosis of the grafts through a left anterior 3-5 cm mini-thoracotomy. PCI will be performed via radial or femoral access according to local routine and is restricted to the RCA.
Off-pump coronary arterial bypass grafting (OPCAB)
Procedure/SurgeryOPCAB will be performed as per clinical routine at each center through a median sternotomy. IMA harvesting (pedicled or skeletonised) follows each center's routine. An anaortic, total arterial strategy with a LIMA-LAD graft and complete revascularisation is obliged.
Composite Absence of Adverse Events within 30 Days Postoperatively (Textbook Outcome)
The primary endpoint is defined as the "Textbook Outcome," which is the composite absence, within 30 days postoperatively, of the following events: * Mortality * Re-exploration for bleeding * Postoperative ischemia (requiring bypass grafting or acute PCI) * Postoperative myocardial infarction (type 5 MI according to the fourth universal definition of myocardial infarction) * Cardiac tamponade (requiring surgical or percutaneous intervention) * Cerebrovascular accident / transient ischemic attack * Wound infection requiring antibiotics or intervention * New-onset atrial fibrillation requiring medical anti-thrombotic therapy * Pneumonia requiring IV or oral antibiotics * Placement of additional chest drains * Prolonged hospital stay (\> 7 days) after surgery
Conversion to Sternotomy
Rate of conversion to sternotomy for minimally invasive coronary surgery (MICS) patients.
Conversion to Cardiopulmonary Bypass
Incidence of hemodynamic support with cardiopulmonary bypass during the surgical procedures.
Intensive Care Unit (ICU) Stay
Duration of ICU stay following the surgical procedure (in days).
Postoperative Hospital Stay
Total length of postoperative hospital stay (in days).
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Catharina Ziekenhuis Eindhoven
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
Eindhoven University of Technology
Collaborator
