MICRA-HYBRID trial

Authors
Category Primary study
Registry of TrialsOverview of Medical Research in the Netherlands
Year 2025
INTERVENTION: Multivessel‐HCR arm:Minimally invasive LIMA or RIMA harvesting (± Y‐T graft configuration radial or RIMA) is anastomosed to all left‐sided targets in an off‐pump fashion.PCI of the RCA during the same admission or within 6 weeks postoperatively at discretion of the interventional cardiologist and per hospital protocol with a drug‐eluting stent (current‐generation zotarolimus‐ or everolimus‐eluting platform).OPCAB arm:Complete arterial grafting of all significant targets in an off‐pump fashion.  CONDITION: ; Coronary Artery Bypass Grafting (CABG) Hybrid Coronary Revascularization (HCR) Minimally Invasive Coronary Surgery (MICS) Off‐pump Corobary Artery Bypass Grafting (CABG) Percutaneous Coronary Intervention (PCI) Bypass surgery Hybrid bypass ssurgery Off‐pump bypass surgery 10007593 10011082 PRIMARY OUTCOME: The primary endpoint is the composite endpoint of patient orientated “Textbook Outcome” at 30‐days after the procedure.Textbook Outcome defined as the absence of:30‐day mortalityRe‐exploration for bleedingPostoperative ischemia (requiring bypass graft revision of acute percutaneous interventionPostoperative myocardial infarction (type 5 MI according to the fourth universal definition of myocardial infarction)Cardiac tamponade (requiring surgical or percutaneous intervention)Cerebrovascular accident Wound infection requiring antibiotics or interventionNew‐onset atrial fibrillation requiring medical anti‐thrombotic therapyPneumonia requiring antibioticsPlacement of additional chest drainsProlonged hospital stay (> 7 days) after surgery SECONDARY OUTCOME: All individual components of the Textbook OutcomeConversion to sternotomy for MICS patientsHemodynamic support with cardiopulmonary bypassLength of intensive care unit (ICU) stayLength of postoperative hospital stayTotal ventilation timeTotal postoperative blood lossNeed for transfusion of blood productsPhrenic nerve injury leading to diaphragm paralysisPostoperative PEF at day 1 and 3  postoperatively and 4 weeks after dischargeQuality of life assessment using the European Quality of Life‐5 Dimensions (EQ‐5D) at baseline and 1 month and 12 months of follow‐up.Angina assessment using the CCS angina classification at baseline, discharge, and 1, 6, and 12 months of follow‐up/ Blood analysesHealth care cost of hospitalization at 30 days (including procedural costs), 6 months and 1 year.MACCE until 5 years follow‐up TVR until 5 years follow‐up INCLUSION CRITERIA: The study population will consist of adult patients aged 18‐85 of either se Xwho presents with angiographically confirmed three‐vessel coronary artery disease or left main coronary artery disease with significant right coronary artery involvement. The population is expected to reflect the usual clinical spectrum of patients undergoing surgical revascularization in Western Europe, including individuals with hypertension, diabetes mellitus, and other common cardiovascular risk factors.Inclusion criteriaPatients 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
Epistemonikos ID: 281b3d74c621d9ed7d1727cf4f854f3002575fd2
First added on: Apr 23, 2026