Objectives
The present trial will in patients undergoing CABG (1) evaluate the complications in
endoscopic versus traditionally harvested radial arteries, (2) evaluate graft patency in
endoscopic harvested radial arteries versus open technique, and (3) evaluate the use of
mammario-radial grafting versus aorto-radial grafting.
Design and trial size
The NEO Trial is a randomised clinical trial with a 2x2 factorial design. We plan to
randomise 300 participants into four intervention groups: (1) mammario-radial endovascular
group; (2) aorto-radial endovascular group; (3) mammario-radial open group and (4)
aorto-radial open group. A subgroup of 100 participants will be selected to undergo a special
scanning of the vascular perfusion of donor and control hands (MIBI scan). The evaluation of
graft patency and ischaemia in the arm will be blinded but the assessment of the primary
outcome of handfunction at three months is non-blinded evaluated by questionnaire.
Trial interventions
Trial 1: The experimental procedure in this trial will be endoscopic radial artery harvest
(ERAH). The control intervention will be open radial artery harvest (ORAH).
Trial 2: The experimental procedure in this trial will be the technique where the radial
artery is sewn onto the mammarian artery as a mammario-radial anastomosis
(composite/Y-graft). The control intervention will be the technique of sewing the radial
artery directly onto the aorta as an aorto-radial anastomosis (free radial artery).
Inclusion and exclusion criteria
All patients referred to our department for sub acute or elective coronary bypass operation
will be eligible for trial inclusion. Inclusion criteria are: 18 years or older; able and
willing to give informed consent; multi-vessel disease. Exclusion criteria are: off-pump
procedure; multi-procedure (i.e. concomitant valve surgery); contrast allergy; geographically
not available for follow-up; Allen's test with insufficient ulnary artery perfusion; no
informed consent; acute operation; dialysis; preoperative neurological deficit on the donor
arm; left ventricle ejection fraction (LVEF) less than 20%; former sternotomy and malignant
disease.
Primary and secondary outcomes
Trial 1: The primary outcome will be evaluation of hand function at three months.
The secondary outcomes will be: occurrence of neurophysiological defects in the donor arm
assessed by examination of cutaneous sensibility and measurements of the sensory and motoric
nervous conduction velocity preoperatively and after three months; change in subjective
cutaneous sensibility assessed by a clinical examination after three months; complications
assessed as a composite of haematoma formation, wound dehiscence or infection registered
before discharge and after three months.
We will also assess a number of exploratory outcomes (serious adverse events, reoperation for
bleeding, revascularisation, myocardial infarction, stroke or death, handgrip strength,
muscular function in the hand, scar evaluation, vascular supply to the hand, graft patency
and participants subjective evaluation of hand function after 1 year).
Trial 2: The primary outcome will be the occurrence of cardio- or cerebrovascular events
during the first year after surgery comparing mammario-radial versus aorto-radial grafts. As
an exploratory outcome we will also assess graft patency by multi-slice computer tomography
(MSCT) comparing mammarioradial versus aortoradial grafts one year after surgery.
Time schedule
Randomisation will commence after 15th of May 2013. The inclusion period of altogether 300
participants is expected to last three years.
