The Ideal Sequence of Hybrid Coronary Revascularization with Endoscopic Coronary Revascularization

Jessa Hospital4 enrolled

Overview

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)

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Standard hybrid coronary revascularizationPROCEDURE

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.

Reverse hybrid coronary revascularizationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Jessa Hospital

Hasselt, Limburg, Belgium

Outcomes

Primary Outcomes

30-day net adverse clinical event (NACE)

NACE consists of major adverse cardiac and cerebrovascular events (MACCE) and major bleeding unrelated to CABG (Bleeding Academic Research Consortium (BARC) type 3 and 5) MACCE consists of: * Death from any cause * Myocardial infarction * Stroke * Target lesion revascularisation

Time frame: From the first procedure until 30 days after the second procedure.

Secondary Outcomes

Key secondary outcome: 30-day major adverse cardiac and cerebrovascular events (MACCE)

MACCE consists of: * Death from any cause * Myocardial infarction * Stroke * Target lesion revascularisation

Time frame: From the first procedure until 30 days after the second procedure

Key secondary outcome: 30-day major or clinically relevant non-major bleeding (BARC type 2, 3, 4, 5)

Major or clinically relevant non-major bleeding is assessed using BARC type 2, 3, 4, and 5.

Time frame: From the first procedure until 30 days after the second procedure

Key secondary outcome: One-year net adverse clinical event (NACE)

Time frame: From the first procedure until one year after the second procedure

Key secondary outcome: one-year major adverse cardiac and cerebrovascular events (MACCE)

MACCE consists of: * Death from any cause * Myocardial infarction * Stroke * Target lesion revascularisation

Time frame: From the first procedure until one year after the second procedure

Data from ClinicalTrials.gov

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