Clinical trial NCT05184075: The Ideal Sequence of Hybrid Coronary Revascularization with Endoscopic Coronary Revascularization
Official title: A Randomized Controlled Trial to Investigate the Ideal Sequence of Hybrid Coronary Revascularization with Endoscopic Coronary Revascularization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Hybrid coronary revascularization
Coronary revascularization
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: 30-day net adverse clinical event (NACE)
timeFrame: From the first procedure until 30 days after the second procedure.
Secondary outcomes:
measure: Key secondary outcome: 30-day major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: From the first procedure until 30 days after the second procedure
measure: Key secondary outcome: 30-day major or clinically relevant non-major bleeding (BARC type 2, 3, 4, 5)
timeFrame: From the first procedure until 30 days after the second procedure
measure: Key secondary outcome: One-year net adverse clinical event (NACE)
timeFrame: From the first procedure until one year after the second procedure
measure: Key secondary outcome: one-year major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: From the first procedure until one year after the second procedure
measure: Key secondary outcome: One-year major or clinically relevant non-major bleeding (BARC type 2, 3, 4, 5)
timeFrame: From the first procedure until one year after the second procedure
measure: Mortality
timeFrame: From the first procedure until one year after the second procedure
measure: Myocardial infarction
timeFrame: From the first procedure until one year after the second procedure
measure: Stent thrombosis
timeFrame: From the first procedure until one year after the second procedure
measure: Stroke
timeFrame: From the first procedure until one year after the second procedure
measure: Revascularization
timeFrame: From the first procedure until one year after the second procedure
measure: Graft failure
timeFrame: From the first procedure until one year after the second procedure
measure: Bleeding
timeFrame: From the first procedure until one year after the second procedure
measure: Quality of Life (QoL) using the Short-form 36 (SF-36) questionnaire
timeFrame: 14, 30, 90, 180 and 365 days after the second procedure
measure: Quality of Life (QoL) using the Euro Quality of Life 5 dimensions (EQ-5D) questionnaire
timeFrame: 14, 30, 90, 180 and 365 days after the second procedure
measure: Quality of Life (QoL) using the Seattle Angina Questionnaire short-form (SAQ-7)
timeFrame: 14, 30, 90, 180 and 365 days after the second procedure
measure: Quality of Life (QoL) using the Rose Dyspnea Scale (RDS)
timeFrame: 14, 30, 90, 180 and 365 days after the second procedure
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Yoann Bataille, PhD
role: PRINCIPAL_INVESTIGATOR
References: