The Ideal Sequence of Hybrid Coronary Revascularization with Endoscopic Coronary Revascularization

NCT ID: NCT05184075

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2024-11-09

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.

The overall aim of this study is to investigate the best sequence within hybrid coronary revascularization using endoscopic coronary bypass grafting (i.e., first CABG then PCI versus first PCI then CABG)

Detailed Description

Hybrid coronary revascularization (HCR) is an emerging approach for multivessel coronary artery disease (MVD) which combines the excellent long-term outcomes of surgery with the early recovery and reduced short-term complications of percutaneous coronary intervention (PCI). However, the best sequence within hybrid coronary revascularization remains unclear. When CABG is performed first (standard HCR), incomplete revascularization can cause acute coronary events in the interim period. On the other hand, when PCI is performed first (reverse HCR), bleeding risks may be higher since CABG should be performed on uninterrupted dual anti-platelet therapy (DAPT). The use of minimally invasive surgery techniques is associated with reduced bleeding because of the less surgical trauma and may offer the opportunity to perform reverse HCR due to the possibility to reduce the risk of bleeding.

The overall aim of this study is to investigate the best sequence within hybrid coronary revascularization using endoscopic coronary bypass grafting (i.e., first CABG then PCI versus first PCI then CABG, figure 1)

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reverse hybrid coronary revascularization (HCR)

Patients will undergo reverse hybrid coronary revascularization. Moreover, quality of life is assessed at baseline, 14 days, 30 days, 90 days, 6 months and 1 year.

Group Type: ACTIVE_COMPARATOR

Reverse hybrid coronary revascularization

Intervention Type: PROCEDURE

Patients will receive a percutaneous coronary intervention (PCI) within four weeks after the diagnostic coronarography. Furthermore, they will undergo the endoscopic coronary artery bypass grafting (endo-CABG) within four weeks after the PCI.

Standard hybrid coronary revascularization (HCR)

Patients will undergo standard hybrid coronary revascularization. Moreover, quality of life is assessed at baseline, 14 days, 30 days, 90 days, 6 months and 1 year.

Group Type: ACTIVE_COMPARATOR

Standard hybrid coronary revascularization

Intervention Type: PROCEDURE

Patients will undergo endoscopic coronary artery bypass grafting (endo-CABG) within four weeks after the diagnostic coronarography. Furthermore, they will receive a percutaneous coronary intervention (PCI) within four weeks after the endo-CABG.

Interventions

Standard hybrid coronary revascularization

Patients will undergo endoscopic coronary artery bypass grafting (endo-CABG) within four weeks after the diagnostic coronarography. Furthermore, they will receive a percutaneous coronary intervention (PCI) within four weeks after the endo-CABG.

Intervention Type: PROCEDURE

Reverse hybrid coronary revascularization

Patients will receive a percutaneous coronary intervention (PCI) within four weeks after the diagnostic coronarography. Furthermore, they will undergo the endoscopic coronary artery bypass grafting (endo-CABG) within four weeks after the PCI.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Multivessel coronary disease, defined as ≥ 50% diameter stenosis by visual estimation in 2 or more of the three major epicardial vessels or major side branches, with at least one or more one stenosis amenable to revascularization with PCI, if the patient cannot be full revascularized by surgery for a specific reason as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if the left anterior descending artery (LAD) and left circumflex have ≥50% stenosis.
• Age 18-85
• Willing and able to provide informed, written consent

Exclusion Criteria

• Requirement for other cardiac or non-cardiac surgical procedures (e.g., valve replacement, carotid revascularization)
• Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support at the time of randomisation
• Left main coronary artery disease
• Contraindication for dual antiplatelet therapy
• ST-Elevation Myocardial Infarction (STEMI)
• Previous cardiac surgery
• Participation in other interventional clinical trials
• Recent coronary intervention (PCI)
• Ongoing high risk non-ST-segment elevation acute coronary syndrome (ACS)
• Life expectancy < 1 year
• Active bleeding more or equal to BARC 2 at time of randomisation
• Requiring renal replacement therapy
• Undergoing evaluation for organ transplantation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoann Bataille, PhD

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

Jessa Hospital

Hasselt, Limburg, Belgium

Countries

Belgium

Other Identifiers

f/2021/085

Identifier Type: -

Identifier Source: org_study_id