Coronary Hybrid Revascularisation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Coronary Hybrid Revascularisation Study Registry on Treatment of Significant Coronary Artery Disease by Combined Bypass Operation (CABG) and Catheter Based Treatment (PCI)

Conditions
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Significant Coronary Artery Disease

Intervention / Treatment
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* Procedure: Combined CABG and PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable, unstable angina pectoris and ACS. Significant stenosis of LAD, segment 1 or 2 and of other coronary arteries. The patient can be treated with a mammary graft to LAD and by balloon or stent of other lesions. Signed informed consent must be available. Exclusion Criteria: Earlier cardiac surgery Treatment with coronary stent within one year. ST-elevation infarction within 24 hours. Coronary artery lesions located to LAD, segment 1 or 2, which cannot be treated by coronary bypass operation. Stenosis of diagonal branches, CX artery and the right coronary artery, which cannot be treated by PCI. Expected survival <1 year following successful treatment. Allergy to aspirin, clopidogrel, ticlopidine and/or prasugrel. Allergy to sirolimus, everolimus, zotarolimus og biolimus For the patients treated with coronary hybrid intervention in the same seance further exclusion criteria: Known disorder of the bloods ability to coagulate (such as renal failure (dialysis or renal creatinine clearance < 50ml/min), congenital coagulopathy, needs for anticoagulant treatment before surgery) Previous gastrointestinal bleeding or previous cerebral
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Result of combined CABG and PCI treatment<br>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. | Procedure: Combined CABG and PCI<br>* Coronary artery bypass grafting Percutaneous coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE |  | After 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined endpoint of death, stroke, MI and new revascularisation. |  | After 1 month and after 1, 3 and 5 years | 
| Individual endpoints of death, stroke, MI and new revascularisation. |  | After 1 month and after 1, 3 and 5 years | 
| Death |  | Baseline, 1 month, 1, 2, 3, 4 and 10 years | 
| Procedure related biomarker release |  | Baseline, 1, 3 and 5 year | 
| Reoperation for bleeding |  | Baseline, 1, 3 and 5 year | 
| Operation for suspected sternal infection |  | Baseline, 1, 3 and 5 year | 
| CT verified pulmonary embolism |  | Baseline, 1, 3 and 5 year | 
| CCS angina class |  | 1, 3 and 5 year | 
| NYHA function class |  | 1, 3 and 5 year | 
| Duration of hospitalisation related to the index treatment |  | Baseline | 
| Duration of admission for the index treatment |  | Baseline | 
| Angiographic endpoints | Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon. | 1 year |