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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 off-pump coronary artery bypass (OPCAB) in selected patients with multivessel coronary artery disease.
- 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-stop hybrid revasularization | Experimental |
| |
| Off-pump coronary artery bypass | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive direct coronary artery bypass | Procedure | MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization. | 1 year |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengshou Hu, M.D. | Contact | 0086-10-8839-8359 | shengshouhu@yahoo.com | |
| Zhe Zheng, M.D. | Contact | 0086-10-8839-8359 | zhengzhefuwai@tom.com |
| Name | Affiliation | Role |
|---|---|---|
| Shengshou Hu, M.D. | China National Center for Cardiovascular Diseases | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| PCI-Drug eluting stents | Procedure | 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). |
|
|
| Off-pump coronary artery bypass | Procedure | Procedure: coronary artery bypass without cardiopulmonary Coronary artery bypass surgery with no associated or concomitant surgical procedures, using full median sternotomy, without cardiopulmonary bypass (CPB) and cardioplegia. |
|
|
| 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 |
| Institute of cardiovascular diseases & Fuwai hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D047549 | Coronary Artery Bypass, Off-Pump |
| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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