Coronary Hybrid Revascularisation Study
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.
|Significant Coronary Artery Disease||Procedure: Combined CABG and PCI||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Coronary Hybrid Revascularisation Study Registry on Treatment of Significant Coronary Artery Disease by Combined Bypass Operation (CABG) and Catheter Based Treatment (PCI)|
- 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 [ Time Frame: 1 year ]Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||October 2019|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: Result of combined CABG and PCI treatment
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
Coronary artery bypass grafting Percutaneous coronary intervention
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496664
|Aarhus University Hospital, Skejby|
|Aarhus N, Denmark, 8200|