The purpose of the registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters. Based on existing literature we expect the results of coronary artery bypass grafting of the anterior descendent coronary artery (LAD), segment 1 and 2, using the so-called mammary artery graft, to be superior to stent treatment of the same artery. At the same time a catheter based intervention using balloon, bare metal stents (BMS) or drug eluting stents (DES) seems to be a better treatment that a saphenous vein graft for other coronary arteries than the LAD. I.e. the right coronary artery (RCA) and the left circumflex coronary artery (CX). Therefore, we expect a combination of the mentioned surgical and catheter based techniques to be a better treatment than bypass operation or catheter based intervention alone.
A total of 150 consecutive patients will be included in the study. The patients will have a coronary artery narrowing located to the LAD, which can be treated with a mammary graft, and a stenosis located to other coronary arteries (RCA and CX), which can be treated by balloon or stent. The patients included in the study will be recruited from patients who are referred to the Department of Cardiology/Department of Thoracic Surgery, Aarhus University Hospital, Skejby for treatment of significant coronary artery disease. We will not announce for patients, and the patients will not receive a honorarium for participation. The first 100 patients will be treated i two seances; operation and stent treatment with few days interval. The last 50 patients will be treated in a hybrid operation room with operation and stent treatment in the same seance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
Coronary artery bypass grafting Percutaneous coronary intervention
Aarhus University Hospital, Skejby
Aarhus N, Denmark
Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE
Time frame: After 1 year
Combined endpoint of death, stroke, MI and new revascularisation.
Time frame: After 1 month and after 1, 3 and 5 years
Individual endpoints of death, stroke, MI and new revascularisation.
Time frame: After 1 month and after 1, 3 and 5 years
Death
Time frame: Baseline, 1 month, 1, 2, 3, 4 and 10 years
Procedure related biomarker release
Time frame: Baseline, 1, 3 and 5 year
Reoperation for bleeding
Time frame: Baseline, 1, 3 and 5 year
Operation for suspected sternal infection
Time frame: Baseline, 1, 3 and 5 year
CT verified pulmonary embolism
Time frame: Baseline, 1, 3 and 5 year
CCS angina class
Time frame: 1, 3 and 5 year
NYHA function class
Time frame: 1, 3 and 5 year
Duration of hospitalisation related to the index treatment
Time frame: Baseline
Duration of admission for the index treatment
Time frame: Baseline
Angiographic endpoints
Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon.
Time frame: 1 year
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