The Ideal Sequence of Hybrid Coronary Revascularization With Endoscopic Coronary Revascularization - Clinical Trial for Coronary Artery Disease | NCT05184075

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Standard hybrid coronary revascularization

Reverse hybrid coronary revascularization

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Hybrid coronary revascularization, Coronary revascularization

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Jessa HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Reverse hybrid coronary revascularization (HCR)

Standard hybrid coronary revascularization (HCR)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Key secondary outcome: One-year 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

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

Key secondary outcome: One-year 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.

Mortality

Both all-cause mortality as the subdivision in cardiovascular death, noncardiovascular death and undetermined cause of death are examined.

Myocardial infarction

Mycardial infarction is subdivided into: Periprocedural Spontaneous

Stent thrombosis

Stent thrombosis is subdivided into: Definite stent thrombosis Probable stent thrombosis Possible stent thrombosis

Stroke

Stroke is subdivided into: Ischemic stroke Hemorrhagic stroke Non-specified stroke

Revascularization

Revascularization is subdivided into: Target lesion revascularization (TLR) Target vessel revascularization (TVR)

Graft failure

Graft failure describes total graft occlusion that prevents blood flow through the graft to the revascularized part of the heart.

Bleeding

Bleeding is assessed using the Bleeding Academic Research Consortium (BARC) classification, Thrombolysis In Myocardial Infarction (TIMI) bleeding classification and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO). classification BARC is subdivided into type zero (no bleeding) until five (probable/definite fatal bleeding), while the TIMI classification is divided into minimal, minor, and major. Gusto is subdivided into mild, moderate, and severe.

Quality of Life (QoL) using the Short-form 36 (SF-36) questionnaire

QoL will be questioned with the Short-form 36 (SF-36) questionnaire.SF-36 scores range from 0 (worst) to 100 (best).

Quality of Life (QoL) using the Euro Quality of Life 5 dimensions (EQ-5D) questionnaire

The Euro Quality of Life 5 dimensions (EQ-5D) questionnaire will be used to assess Quality of Life. Questions of the descriptive system are scored from one (no problem to perform activity) to five (severe problem/unable to perform activity). The scores are combined in order to calculate an index value (ranging from 0-1) that reflects the health state with one being the best health state. Moreover, the visual analogue scale ranges from 0 to 100 with 0 representing the worst health state and 100 the best health state.

Quality of Life (QoL) using the Seattle Angina Questionnaire short-form (SAQ-7)

QoL will be questioned with the Seattle Angina Questionnaire short-form (SAQ-7). The overall summary score ranges from 0 to 100 where higher ratings indicate a better health state.

Quality of Life (QoL) using the Rose Dyspnea Scale (RDS)

The Rose Dyspnea Scale (RDS) will be used to assess Quality of Life. RDS is scored between zero and four. Zero corresponds to no dyspnea with activity and four to dyspnea that severly limits activity.

Full Information

NCT ID

NCT05184075

First Posted

December 20, 2021

Last Updated

January 20, 2023

Sponsor

Jessa Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05184075

Brief Title

The Ideal Sequence of Hybrid Coronary Revascularization With Endoscopic Coronary Revascularization

Acronym

HYBRID

Official Title

A Randomized Controlled Trial to Investigate the Ideal Sequence of Hybrid Coronary Revascularization With Endoscopic Coronary Revascularization

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 9, 2023 (Actual)

Primary Completion Date

June 9, 2024 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Hybrid coronary revascularization, Coronary revascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Reverse hybrid coronary revascularization (HCR)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Standard hybrid coronary revascularization (HCR)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Standard hybrid coronary revascularization

Intervention Description

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

Intervention Name(s)

Reverse hybrid coronary revascularization

Intervention Description

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.

Primary Outcome Measure Information:

Title

30-day net adverse clinical event (NACE)

Description

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 Outcome Measure Information:

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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