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
Conditions
Interventions
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
Sponsors
Catharina Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The study population will consist of adult patients aged 18-85 of either sex who 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
Exclusion criteria
Exclusion criteria: Exclusion criteriaA potential participant who meets any of the following criteria will be excluded from participation in this study:Age < 18 or > 85 yearsChronic total occlusion of the right coronary artery (RCA)In-stent RCA restenosisRCA restenosis with high-risk clinical features requiring urgent PCI or surgical revascularizationReverse hybrid coronary revascularization, defined as PCI-RCA followed by surgical revascularizationAcute cardiac ischemiaLeft ventricular ejection fraction < 30 %eGFR < 30 ml/minIndication for concomitant cardiac surgery (e.g. valve or arrhythmia surgery) or non-cardiac surgeryPrevious thoracic or cardiac surgery, mediastinal irradiation, significant trauma to the chestPreoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure) or cancer. Hemodynamically significant left subclavian stenosisSevere chest wall deformities History of pericarditisBody mass index > 40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Netherlands
Contacts
Public ContactF Akca
Catharina Ziekenhuis
Outcome results
None listed