Efficacy and Safety of One-Stage Hybrid Coronary Revascularization

Study Overview
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Brief Summary
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Coronary revascularization could be accomplished either by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). PCI with drug-eluting stent (DES) implantation is featured by minimal invasive, low complication and rapid rehabilitation. CABG is characterized by improved long-term, event-free survival attributable to the use of left internal mammary artery (LIMA) graft. Hybrid coronary revascularization (HCR) consists of LIMA bypass to left anterior coronary descending artery (LAD) by minimal invasive direct coronary artery bypass (MIDCAB) and PCI of other stenosed coronary arteries with DES implantation. One-step HCR entails LIMA-LAD anastomosis performed through MIDCAB, immediately followed by PCI for non-LAD lesions, sometimes for diagonal branch, in the hybrid operating room. Limited data are available in comparing one-step HCR to PCI alone for the treatment of multivessel coronary artery disease(MVD). The current EAST-HCR study will investigate the efficacy and safety of one-step HCR for patients with MVD, as comparing to PCI alone.

Official Title
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Efficacy and Safety of One-Step Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for Patients With Multivessel Disease

Conditions
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Multivessel Coronary Artery Disease

Intervention / Treatment
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* Procedure: coronary revascularization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years and older signed the informed consent indicated for revascularization, with possible bypass segment in LAD and amendable lesions by PCI in other vessels anatomy requiring as following: (1) Multivessel CAD involving the LAD (proximal or mid) and/or LM (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment in LCX or RCA, including: (2) LAD disease, and a major diagonal lesion, either bifurcation or independent in location, with both requiring revascularization (determined by QFR or FFR) (3) LM distal bifurcation lesion (Medina 1,1,1), intended for 2-stent approach if randomized to PCI Heart team discussion after angiogram, with conclusion of suitable candidate for either PCI or HCR Able to tolerate and no plans to interrupt dual anti-platelet therapy for 3 12 months Willing to comply with 2-year clinical follow-up Exclusion Criteria: Previous cardiac or thoracic surgery Previous PCI of the LM and/or LAD within 12 months Totally occluded left main vessel Cardiogenic shock or LVEF <30% Previous STEMI within 30-day prior to randomization Concomitant vascular or other cardiac disease with plan of surgical treatment Indication for chronic oral anticoagulation therapy Previous stroke history within 6-month prior to randomization Survival expectation less than 3 years due to non-cardiac illness Allergy or hypersensitivity to any of the study drugs or devices used in the trial Enrolled in additional clinical study Informed consent not available or noncompliance with follow-up Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one-step Hybrid Coronary Revascularization (HCR)<br>One-step HCR is defined as off-pump MIDCAB LIMA-LAD revascularization immediately followed by PCI for at-least one non-LAD lesion(or LAD-diagonal lesion) with DES implantation in a hybrid operating room. | Procedure: coronary revascularization<br>* to improve the blood supply for coronary arteries by using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)<br>|
| Active Comparator: Percutaneous Coronary Intervention (PCI)<br>PCI will be performed using standard technique at the discretion of interventional cardiologist with DES implantation in a routine catheter lab. | Procedure: coronary revascularization<br>* to improve the blood supply for coronary arteries by using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) | the occurrence of MACCE at 2 years' clinical follow-up, including all-cause death, myocardial infarction, stroke, and repeated revascularization | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding events | individual component of MACCE | 2 years | 
| Hospital duration (day) |  | up yo 2 years | 
| Rate of complete revascularization at index hospitalization | rate of complete revascularization at index hospitalization (defined by Quantitative flow ration[QFR] or Fraction flow reserve[FFR]) | 2 years | 
| Stent thrombosis event | stent thrombosis defined by Academic Research Consortium (ARC) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hybrid coronary revascularization (HCR), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), multivessel coronary artery disease