Hybrid Revascularization Versus Coronary Artery Bypass Grafting

NCT05504031 | Not Yet Recruiting DMC

• 1 other identifier: Hybrid-CABG Trial CPH
• Study Type: interventional
• Target: 1,048
• Locations: 0 countries
• Sites: N/A

Brief Summary

Coronary artery disease often necessitates complex interventions like coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) with stents. Hybrid coronary revascularization, a minimally invasive approach, integrates both methods for complete revascularization. This multicenter randomized trial involves 1200 patients, comparing hybrid coronary revascularization to CABG in a 1:1 ratio. Eligible participants have multi-vessel coronary disease and are referred for elective or sub-acute CABG. Inclusion criteria include age 18 or older, significant multi-vessel disease, and potential complete revascularization with both methods. Exclusion criteria include chronic kidney disease, pregnancy, contradiction to dual antiplatelet therapy, recent myocardial infarction, and acute revascularization. The hybrid group undergoes staged revascularization, combining minimally invasive grafting of the left interior mammary artery to the left anterior descending artery with PCI-stenting of remaining lesions. The control group undergoes conventional CABG with sternotomy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, or unplanned hospitalization, while secondary outcomes include periprocedural complications, cardiovascular mortality, hospital-free days within 90 days, angina frequency, and quality of life. Evaluation occurs 12 months after randomization. The trial commences in 2024, with inclusion expected to conclude in 5 years.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Hybrid coronary revascularization; PCI; CABG

Outcome Measures

Primary Outcomes (1)

• A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization

  A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization

  12 months after randomization

Secondary Outcomes (4)

• Angina symptoms

  12 months after randomization

• Health related quality of life

  12 months after randomization

• Hospital free days

  90 days after randomization

• Procedural complications

  12 months after randomization

Study Arms (2)

Hybrid Group

EXPERIMENTAL

Revascularization in the form of a combined MIDCAB (LIMA-LAD graft trough a minimal invasive left anterior thoracotomy) and PCI (of all non-LAD stenoses)

Procedure: Hybrid coronary revascularization

CABG Group

ACTIVE COMPARATOR

Conventional CABG through a sternotomy

Procedure: Conventional revascularization

Interventions

Hybrid coronary revascularization PROCEDURE

Coronary revascularization is conducted as a combined MIDCAB (LIMA-LAD grafting through a minimally invasive anterior left thoracotomy) and PCI (of all non-LAD stenoses)

Hybrid Group

Conventional revascularization PROCEDURE

Conventional revascularization with CABG of all significant stenoses through a sternotomy

CABG Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• ≥ 18 years of age
• Functionally significant MVD, defined as ≥ 70% diameter stenosis by visual estimation or functionally significant stenosis (FFR \< 0.80, non-hyperaemic index (iFR) \< 0.89) in at least two of the major epicardial vessels or major side branches
• Patient history reviewed by both cardiac surgeon and cardiologist who in agreement find both CABG and hybrid revascularisation indicated and technically feasible with an expectation of complete revascularisation of all functionally significant stenoses in the LAD and at least one other coronary artery ≥ 2.5mm in diameter or left main bifurcation stenosis with functionally significant stenoses in both the LAD and left circumflex artery.

You may not qualify if:

• Chronic kidney disease with estimated glomerular filtration rate \< 20 mL/min/kg
• Pregnancy
• Left main stenosis without additional functionally significant stenoses in both the LAD and the LCX
• Contraindications to the use of dual antiplatelet therapy
• STEMI within 1 month
• Indication for acute revascularization

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• UMC Utrecht: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Christian Carranza, MD, E-MBA

  Department of Cardiothoracic Surgery, Copenhagen University Hospital, Denmark

  STUDY DIRECTOR

Central Study Contacts

Erika Nodin, MD

CONTACT

004535457477; enod0001@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We intend to blind all possible trial personal. Participants and care providers can not be blinded due to obvious scaring on the patient and the ward that is responsible for patient care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Model Details: 1:1 randomization to Hybrid coronary revascularization or CABG

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2040
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the end of the trial
• Access Criteria: In peer-review papers