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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one-step Hybrid Coronary Revascularization (HCR) | Experimental | 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. |
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| Percutaneous Coronary Intervention (PCI) | Active Comparator | PCI will be performed using standard technique at the discretion of interventional cardiologist with DES implantation in a routine catheter lab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coronary revascularization | Procedure | to improve the blood supply for coronary arteries by using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Zhang, MD, PhD | Contact | +86-21-38804518 | zhangqnh@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qi Zhang, MD, PhD | Shanghai East Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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 |
| D019060 | Minimally Invasive Surgical Procedures |