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NOT YET RECRUITING
NCT05504031
NA

Hybrid Revascularization Versus Coronary Artery Bypass Grafting

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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.

Official title: Hybrid Revascularization Versus Coronary Artery Bypass Grafting in Patients With Multi-vessel Coronary Artery Disease. A Randomized Clinical Trial.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1048

Start Date

2025-01

Completion Date

2040-12

Last Updated

2024-04-17

Healthy Volunteers

No

Interventions

PROCEDURE

Hybrid coronary revascularization

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)

PROCEDURE

Conventional revascularization

Conventional revascularization with CABG of all significant stenoses through a sternotomy