HYBRID: The Ideal Sequence of Hybrid Coronary Revascularization With Endoscopic Coronary Revascularization
Study Details
Study Description
Brief Summary
Hybrid coronary revascularization (HCR), a combination of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI), has emerged as an alternative treatment for multivessel coronary artery disease patients. However, the ideal sequence (PCI or CABG) is unclear.
Therefore, the aim of this non-inferiority randomized controlled trial is to investigate the ideal sequence of hybrid coronary revascularization with endoscopic coronary revascularization.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
When two or more vessels are occluded in coronary artery disease, the optimal revascularization strategy remains uncertain. Hybrid coronary revascularization (HCR), a combination of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), has emerged as an alternative treatment for multivessel coronary artery disease patients. The standard procedures, CABG or PCI alone, could have some limitations. A heavily calcified proximal aorta or a poor target vessel could be a problem for CABG. Simultaneously, the left anterior descending (LAD) coronary artery could be unfavorable for PCI due to excessive vessel tortuosity or chronic total occlusion. In HCR, the advantages of both PCI and totally endoscopic CABG (endo-CABG) are combined. The use of the left internal mammary artery (LIMA) and right internal mammary artery (RIMA) for bypassing the LAD and PCI for non-LAD coronary lesions could be a feasible alternative. A meta-analysis of more than 1100 patients states that hybrid revascularisation outcomes are similar to CABG alone.However, all these studies used a mini-sternotomy or thoracotomy during the surgery. The use of totally endoscopic procedures could improve the outcomes after hybrid revascularization. Secondly, the ideal sequence (PCI or CABG) is unclear.
Therefore, the aim of this non-inferiority randomized controlled trial is to investigate the ideal sequence of hybrid coronary revascularization with endoscopic coronary revascularization.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: PCI - endo-CABG Patients will receive a PCI within two weeks after the diagnostic coronarography. Furthermore, they will undergo the endo-CABG within two weeks after the PCI. |
Procedure: Hybrid coronary revascularization
Patients will receive a PCI and undergo an endo-CABG.
|
| Other: endo-CABG - PCI Patients will undergo the endo-CABG within two weeks after the diagnostic coronarography. Furthermore, they will receive a PCI within two weeks after the endo-CABG. |
Procedure: Hybrid coronary revascularization
Patients will receive a PCI and undergo an endo-CABG.
|
Outcome Measures
Primary Outcome Measures
- Major or clinically relevant non-major bleeding [Until 30 days postoperative]
The Bleeding Academic Research Consortium (BARC) is used to assess bleeding. Type 2, 3, 4 or 5 correspond to major or clinically relevant non-major bleeding. Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional Type 3 Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision Type 4: CABG-related bleeding within 48 hours Type 5 Probable fatal bleeding Definite fatal bleeding (overt or autopsy or imaging confirmation)
- Net adverse clinical event (NACE) [Until 30 days postoperative]
Net adverse clinical event consists of major adverse cardiac and cerebrovascular events (MACCE) + major bleeding unrelated to CABG MACCE consists of: death from any cause myocardial infarction stroke The Bleeding Academic Research Consortium (BARC) is used to assess bleeding. Type 3, and 5 correspond to major bleeding unrelated to CABG. Type 3 Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision Type 5 Probable fatal bleeding Definite fatal bleeding (overt or autopsy or imaging confirmation)
Secondary Outcome Measures
- Major adverse cardiac and cerebrovascular events (MACCE) [Until one year postoperative]
MACCE consists of: Death from any cause Myocardial infarction Stroke
- Death [Until one year postoperative]
All-cause mortality Cardiovascular death Noncardiovascular death Undetermined cause of death
- Myocardial infarction [Until one year postoperative]
The occurence of myocardial infarction
- Stent thrombosis [Until one year postoperative]
Definite stent thrombosis Probable stent thrombosis
- Stroke [Until one year postoperative]
Ischemic stroke Hemorrhagic stroke Non-specified stroke
- Graft failure [Until one year postoperative]
Graft failure registered until one year postoperative
- Revascularization [Until one year postoperative]
Target lesion revascularization (TLR) Target vessel revascularization (TVR)
- Bleeding [Until one year postoperative]
Bleeding is assessed using three classification scales: Bleeding Academic Research Consortium (BARC) classification Thrombolysis In Myocardial Infarction (TIMI) bleeding classification Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification
- Quality of Life (QoL) using the Short-form 36 (SF-36) questionnaire [14, 30, 90, 180 and 365 days postoperative]
QoL will be questioned with the Short-form 36 (SF-36) questionnaire.
- Quality of Life (QoL) using the Euro Quality of Life 5 dimensions (EQ-5D) questionnaire [14, 30, 90, 180 and 365 days postoperative]
The Euro Quality of Life 5 dimensions (EQ-5D) questionnaire will be used to assess Quality of Life.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Multivessel coronary disease
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Age > 18
Exclusion Criteria:
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Haemodynamic Unstable patients (Cardiogenic Shock)
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Contra indication for dual anti platelet therapy
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ST-Elevation Myocardial Infarction (STEMI)
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Previous cardiac surgery
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Participation in other interventional clinical trials
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jessa Hospital
Investigators
- Principal Investigator: Yoann Bataille, PhD, Jessa Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- f/2021/085