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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Result of combined CABG and PCI treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined CABG and PCI | Procedure | Coronary artery bypass grafting Percutaneous coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE | After 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Skejby | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30903175 | Derived | Rimestad JM, Christiansen EH, Modrau IS. One-year cost-effectiveness and safety of simultaneous hybrid coronary revascularization versus conventional coronary artery bypass grafting. Interact Cardiovasc Thorac Surg. 2019 Aug 1;29(2):217-223. doi: 10.1093/icvts/ivz083. Epub 2019 Mar 21. | |
| 26432721 | Derived | Modrau IS, Holm NR, Maeng M, Botker HE, Christiansen EH, Kristensen SD, Lassen JF, Thuesen L, Nielsen PH; Hybrid Coronary Revascularization Study Group. One-year clinical and angiographic results of hybrid coronary revascularization. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1181-6. doi: 10.1016/j.jtcvs.2015.08.072. Epub 2015 Aug 28. |
| Label | URL |
|---|---|
| Feasibility and early safety of hybrid coronary revasculatisation combining off-pump coronary surgery through J-hemisternotomy with percutaneous coronary intervention | View source |
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| 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 |
| 24103704 | Derived | Modrau IS, Nielsen PH, Botker HE, Christiansen EH, Krusell LR, Kaltoft AK, Maeng M, Terkelsen CJ, Kristensen SD, Lassen JF, Thuesen L. Feasibility and early safety of hybrid coronary revascularisation combining off-pump coronary surgery through J-hemisternotomy with percutaneous coronary intervention. EuroIntervention. 2015 Feb;10(10):e1-6. doi: 10.4244/EIJV10I10A195. |
| One year clinical and angiographic results of hybrid coronary revascularisation | View source |
| Related Info | View source |