Comparison of One-stop Hybrid Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Disease

Study Overview
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Brief Summary
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The one-stop hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced operating room equipped with radiographic capability. This study is to compare 1-year clinical outcomes of one-stop hybrid coronary revascularization with percutaneous coronary intervention (PCI) in selected patients with multivessel coronary artery disease.

Detailed Description
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Rationale and purpose of this study: One-stop (also named simultaneous) hybrid coronary revascularization has emerged as a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). The benefits of one-stop hybrid procedure compared with conventional PCI are unclear, however. This study is a single center randomized clinical trial to compare the safety and efficacy of one-stop hybrid procedure with conventional PCI in the treatment of selected patients with multivessel CAD requiring revascularization with suitable coronary anatomy. Sample size: We examined the results of SYNTAX trial and of the hybrid procedures published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 18% for PCI/stenting and 8% for the hybrid group. The sample calculated for this trial is 480 patients. Design/Methodology: Trial design: A single center randomized clinical trial comparing one-stop hybrid procedure versus conventional PCI with SES in 480 patients with suitable anatomy who need revascularization. Intervention: Patients will be randomized to undergo either one-stop hybrid procedure or conventional PCI with SES. Randomization: Patients will be evaluated by both a cardiac surgeon and an interventional cardiologist. After obtaining informed written consent, patients will be randomized to receive one-stop hybrid procedure or conventional PCI with SES. An expertise-based randomization will be used. The data adjudicators will be blinded to the study. Due to the nature of this study, the operating surgeons, cardiologists, anesthetists, other operative room staff, and ICU staff will not be blind in this study. Study intervention: Candidates will be randomized to receive one-stop hybrid procedure or conventional PCI.

Official Title
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Comparison of One-stop Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Hybrid MIDCAB/PCI
* Procedure: PCI with DES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Two- or three-vessel disease, left main disease, or LM equivalent with 2 or 3-vessel disease (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory) Denovo lesions of LAD , with obstruction >=70%, especially chronic totally occlusion (CTO), severe calcification or bifurcation lesion of the LM; Angiographic characteristics of non-LAD lesion(s) amiable to PCI/stenting; Chronic stable or unstable angina pectoris of CCS 2 or greater (symptoms of angina and/or objective evidence of myocardial ischemia); Evaluated by both cardiac surgeon and cardiologist together. Exclusion Criteria: Need for emergent CABG; Prior CABG; Prior PCI with stenting within 6 months of study entry; Stroke with 6 months of study entry; Overt congestive heart failure; Need for a concomitant operation (i.e. valve repair or replacement, Maze surgery); Hemodynamic instability; Situations in which complete revascularization is not possible served; Allergy to radiographic contrast, aspirin or clopidogrel. Contradictions to PCI: Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels <1.5mm; Intolerance to aspirin or both clopidogrel and ticlopidine; Cannot undergo either CABG or PCI/DES because of a coexisting medical condition History of significant bleeding; Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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-stop hybrid coronary revasularization<br>Percutaneous Coronary Intervention; Coronary Artery Bypass | Procedure: Hybrid MIDCAB/PCI<br>* MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia. PCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB. Device: Polymer-based Sirolimus-Eluting Stents (SES).<br>|
| Active Comparator: PCI with stenting<br>Percutaneous Coronary Intervention | Procedure: PCI with DES<br>* Polymer-based Sirolimus-Eluting Stents (SES)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall MACCE rate. |  | 30 days after procedure and 2 years after enrollment | 
| Cardiac death. |  | 30 days after procedure, 1 and 2 years after enrollment | 
| Documented myocardial infarction. |  | 30 days after procedure, 1 and 2 years after enrollment | 
| Target lesion revascularization. |  | 30 days after procedure, 1 and 2 years after enrollment | 
| Recurrence of Angina. |  | 1 and 2 years after enrollment | 
| Cost-effectiveness analysis. |  | 1 and 2 years after enrollment | 
| Quality of life. |  | 6 months, 1 and 2 years after enrollment | 
| Rehospitalization. |  | 6 months, 1 and 2 years after enrollment | 
| Stent thrombosis. |  | 30 days after procedure, 6 months, 1 and 2 years after enrollment |