Comparison of One-stop Hybrid Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Disease

• Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  

• Overall MACCE rate. [ Time Frame: 30 days after procedure and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  
• Cardiac death. [ Time Frame: 30 days after procedure, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  
• Documented myocardial infarction. [ Time Frame: 30 days after procedure, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  
• Target lesion revascularization. [ Time Frame: 30 days after procedure, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  
• Recurrence of Angina. [ Time Frame: 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  
• Cost-effectiveness analysis. [ Time Frame: 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  
• Quality of life. [ Time Frame: 6 months, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  
• Rehospitalization. [ Time Frame: 6 months, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  

- With the development of specialized devices and experience, off-pump coronary artery bypass (OPCAB) has been a well-established less invasive technique for coronary revascularization. Compared with conventional on-pump coronary artery bypass grafting (CABG), OPCAB avoids the use of cardiopulmonary bypass and cardioplegic arrest, and is associated with decreased morbidity, shorter length of stay in ICU and hospital, and less perioperative complications, especially in elderly patients with severe comorbidities. "One-stop" (also named simultaneous) hybrid coronary revascularization is also a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). It allows surgical and interventional procedures to be performed consecutively in the "one-stop" hybrid operating suite, an enhanced operating room equipped with radiographic capability, wherein the left intramammary artery (LIMA) is placed on the left anterior descending artery (LAD) by minimally invasive procedure, immediately followed by percutaneous coronary intervention/stenting on the non-LAD lesions. However, few studies are now available on the outcomes of coronary revascularization between the new hybrid strategy with conventional OPCAB. This study is a single center randomized clinical trial to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with OPCAB in selected patients with multivessel CAD with suitable coronary anatomy.

Sample size:

- We examined the results of SYNTAX trial and of our institution published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 13% for OPCAB. The sample calculated for this trial is 400 patients.

Design/Methodology:

- Trial design: A single center randomized clinical trial comparing "one-stop" hybrid procedure versus conventional OPCAB in 400 patients with suitable anatomy who need revascularization.

Intervention: Patients will be randomized to undergo either "one-stop" hybrid procedure or conventional OPCAB.

- 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 OPCAB. 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 OPCAB.