Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronary Artery Bypass Grafting

NCT07314138 | Not Yet Recruiting DMC

• 1 other identifier: NL-010448
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 2

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.

Conditions

Bypass, Cardiopulmonary; Minimally Invasive Coronary Revascularization Surgery; Off-pump Coronary Artery Bypass; Coronary Artery Disease (CAD)

Keywords

minimally invasive coronary surgery; percutaneous coronary intervention; off-pump coronary artery bypass grafting; hybrid coronary revascularization; heart surgery

Outcome Measures

Primary Outcomes (1)

• 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

  30 days postoperatively

Secondary Outcomes (15)

• Conversion to Sternotomy

  Peri-operatively

• Conversion to Cardiopulmonary Bypass

  Peri-operatively

• Intensive Care Unit (ICU) Stay

  30 days postoperatively

• Postoperative Hospital Stay

  30 days postoperatively

• Mechanical Ventilation Time

  30 days postoperatively

Study Arms (2)

Multivessel hybrid coronary revascularization (HCR)

ACTIVE COMPARATOR

Minimally invasive coronary artery bypass surgery to the left sided coronary vessels combined with percutaneous coronary intervention to the right coronary artery.

Procedure: Multivessel Hybrid Coronary Revascularization

Off-pump coronary artery bypass grafting (OPCAB)

ACTIVE COMPARATOR

Total arterial, anaortic off-pump ccoronary artery bypass grafting through median sternotomy.

Procedure: Off-pump coronary arterial bypass grafting (OPCAB)

Interventions

Multivessel Hybrid Coronary Revascularization PROCEDURE

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.

Multivessel hybrid coronary revascularization (HCR)

Off-pump coronary arterial bypass grafting (OPCAB) PROCEDURE

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.

Off-pump coronary artery bypass grafting (OPCAB)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Eindhoven University of Technology: collaborator

Study Sites (2)

University Hospitals Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Catharina Hospital Eindhoven

Eindhoven, Eindhoven, 5623 EJ, Netherlands

Location

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MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ferdi Akca, MD, PhD

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

• Wouter Oosterlinck, Prof. Dr. MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  STUDY CHAIR

• Pim Tonino, Prof. Dr. MD, PhD

  Catharina Ziekenhuis Eindhoven

  STUDY CHAIR

Central Study Contacts

Ferdi Akca, MD, PhD

CONTACT

+31 40 239 9111; ferdi.akca@catharinaziekenhuis.nl

Ismail Cenik, MD

CONTACT

+31 40 239 9111; ismail.cenik@catharinaziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Dual center, superiority, randomized controlled trial.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2034
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

NL (1); BE (1)