Clinical trial NCT01496664: Coronary Hybrid Revascularisation Study
Official title: Coronary Hybrid Revascularisation Study Registry on Treatment of Significant Coronary Artery Disease by Combined Bypass Operation (CABG) and Catheter Based Treatment (PCI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Significant Coronary Artery Disease
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE
timeFrame: After 1 year
Secondary outcomes:
measure: Combined endpoint of death, stroke, MI and new revascularisation.
timeFrame: After 1 month and after 1, 3 and 5 years
measure: Individual endpoints of death, stroke, MI and new revascularisation.
timeFrame: After 1 month and after 1, 3 and 5 years
measure: Death
timeFrame: Baseline, 1 month, 1, 2, 3, 4 and 10 years
measure: Procedure related biomarker release
timeFrame: Baseline, 1, 3 and 5 year
measure: Reoperation for bleeding
timeFrame: Baseline, 1, 3 and 5 year
measure: Operation for suspected sternal infection
timeFrame: Baseline, 1, 3 and 5 year
measure: CT verified pulmonary embolism
timeFrame: Baseline, 1, 3 and 5 year
measure: CCS angina class
timeFrame: 1, 3 and 5 year
measure: NYHA function class
timeFrame: 1, 3 and 5 year
measure: Duration of hospitalisation related to the index treatment
timeFrame: Baseline
measure: Duration of admission for the index treatment
timeFrame: Baseline
measure: Angiographic endpoints
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Skejby
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.