Bypass, Cardiopulmonary, Coronary Artery Disease (CAD), Minimally Invasive Coronary Revascularization Surgery, Off-pump Coronary Artery Bypass
Conditions
Keywords
minimally invasive coronary surgery, percutaneous coronary intervention, off-pump coronary artery bypass grafting, hybrid coronary revascularization, heart surgery
Brief summary
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.
Detailed description
Coronary artery disease remains the leading cause of cardiovascular mortality worldwide. For complex, multivessel disease, surgical revascularization via CABG or OPCAB remains the guideline-recommended standard due to superior long-term outcomes compared with PCI alone. However, traditional sternotomy CABG/OPCAB is associated with significant surgical trauma, prolonged recovery, and elevated perioperative morbidity. Minimally invasive coronary surgery (MICS) with off-pump arterial grafting through a small thoracotomy has shown favorable short-term recovery and lower morbidity in both single and multivessel disease cases. Traditionally, MICS has been limited to grafting the left anterior descending artery (LAD), with other coronary lesions treated by PCI, known as hybrid coronary revascularization (HCR). While most studies have focused on single-vessel HCR (typically LAD), the potential long-term benefits of including the circumflex (Cx) artery in a multivessel-HCR strategy remain unexplored. Given that three-vessel CAD is the most common indication for CABG, evaluating a multivessel-HCR approach (LAD + Cx via MICS, RCA via PCI) is essential. The MICRA-HYBRID trial will randomize 250 patients with three-vessel coronary disease eligible for complete revascularization to either multivessel-HCR or conventional total-arterial OPCAB (median sternotomy, anaortic, off-pump). The primary efficacy endpoint is a composite "Textbook Outcome" at 30 days, defined by absence of death, MI, stroke, re-exploration for bleeding, and other major complications. Secondary endpoints include individual components of the Textbook Outcome, perioperative recovery parameters (ICU/hospital length of stay, ventilator time, transfusion requirement), health-related quality of life (EQ-5D), pulmonary recovery metrics, angina class (CCS), and long-term outcomes including MACCE and target-vessel revascularization up to five years.
Interventions
PROCEDUREMultivessel Hybrid Coronary Revascularization
Multivessel-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.
PROCEDUREOff-pump coronary arterial bypass grafting (OPCAB)
OPCAB 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.
Sponsors
Catharina Ziekenhuis Eindhoven
Universitaire Ziekenhuizen KU Leuven
Eindhoven University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dual center, superiority, randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
A potential participant who meets any of the following criteria will be excluded from participation in this study: * 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. * Reverse hybrid coronary revascularization, defined as PCI-RCA followed by surgical re-vascularization. * Acute cardiac ischemia necessitating immediate intervention. * EF \< 30 % * eGFR \< 30 ml/min * Indication for concomitant cardiac surgery (e.g. valve or arrhythmia surgery) or non-cardiac surgery * Previous thoracic or cardiac surgery, mediastinal irradiation, significant trauma to the chest * Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure) or cancer. * Hemodynamically significant left subclavian stenosis * Severe chest wall deformities * History of pericarditis * Body mass index \> 40 Kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Absence of Adverse Events within 30 Days Postoperatively (Textbook Outcome) | 30 days postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to Sternotomy | Peri-operatively | Rate of conversion to sternotomy for minimally invasive coronary surgery (MICS) patients. |
| Conversion to Cardiopulmonary Bypass | Peri-operatively | Incidence of hemodynamic support with cardiopulmonary bypass during the surgical procedures. |
| Intensive Care Unit (ICU) Stay | 30 days postoperatively | Duration of ICU stay following the surgical procedure (in days). |
| Postoperative Hospital Stay | 30 days postoperatively | Total length of postoperative hospital stay (in days). |
| Mechanical Ventilation Time | 30 days postoperatively | Total ventilation time during the postoperative period (in hours). |
| Postoperative Blood Loss | 30 days postoperatively | Total volume of postoperative blood loss (in milliliters) postoperatively. |
| Transfusion Requirement | 30 days postoperatively | Need for transfusion of blood products (packed units of thrombocyt, red blood cells and plasma) during the postoperative period |
| Phrenic Nerve Injury | 30 days postoperatively | Incidence of phrenic nerve injury leading to diaphragm paralysis. |
| Postoperative Peak Expiratory Flow (PEF) | 30 days postoperatively | PEF measurement at Day 1 and Day 3 postoperatively, and at 4 weeks post-discharge. |
| Quality of Life Assessment (EQ-5D) | 1 year | Quality of life assessment using the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at baseline (screening), 2 weeks and 4 weeks postoperatively and at 12 months follow-up |
| Angina Assessment (CCS Classification) | 1 year | Assessment of angina using the Canadian Cardiovascular Society (CCS) classification at baseline, discharge and every 3 months for up to 1 year |
| Short-term Healthcare Costs | 30 days | Healthcare costs associated with hospitalization within 30 days postoperatively (in euros), including expenses for surgical and percutaneous procedures, diagnostic tests, ICU care, nursing days, reinterventions, complications, and post-discharge admissions (e.g., emergency visits, re-admissions, primary care consultations). |
| Long-term Healthcare Costs | 1 year | Healthcare costs within 1 year postoperatively (in euros), including expenses for diagnostic tests, reinterventions, emergency visits, re-admissions, primary care consultations, repeat visits, telephone, video, and written consultations, as well as after-hours urgent care (e.g., on-call GP visits). |
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 5 years | Incidence of MACCE including mortality, stroke and myocardial infarction up to 5 years post-procedure. |
| Target Vessel Revascularization (TVR) | 5 year | Incidence TVR up to 5 years post-procedure. |
Countries
Belgium, Netherlands
Contacts
CONTACTFerdi Akca, MD, PhD
CONTACTIsmail Cenik, MD
PRINCIPAL_INVESTIGATORFerdi Akca, MD, PhD
Catharina Ziekenhuis Eindhoven
STUDY_CHAIRWouter Oosterlinck, Prof. Dr. MD, PhD
Universitaire Ziekenhuizen KU Leuven
STUDY_CHAIRPim Tonino, Prof. Dr. MD, PhD
Catharina Ziekenhuis Eindhoven
Outcome results
None listed