Clinical trial NCT01848886: Neurological Complications Comparing Endoscopically vs. Open Harvest of the Radial Artery
Official title: Endoscopic Versus Open Radial Artery Harvest and Mammario-radial Versus Aorto-radial Grafting in Patients Undergoing Coronary Artery Bypass Surgery (The 2x2 Factorial Designed Randomised NEO Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications Due to Coronary Artery Bypass Graft
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Keywords: ERAH
Endoscopic Radial Artery Harvest
Y-graft
Radial Artery Harvest
Total Arterial Revascularisation
CABG
Radial Artery Conduit
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Coronary artery bypass grafting (CABG) using the radial artery (RA) has since the nineties gone through a revival. The initially reported worse outcome in RA graft patients compared to patients grafted with the saphenous vein (SV) has since been corrected. Studies have shown better patency when using RA, so the RA is going to be preferred more and more especially in younger patients where long time patency is critical. During the last 10 years endoscopic techniques to harvest the RA have evolved. Multiple different techniques have been used, but now the equipment and technique have been refined and are highly reliable. The investigators hypothesize that the endoscopic technique has less complications and a just as good patency as open harvest. There are also two possible ways to use the RA as a graft. One way is sewing it onto the aorta and another way is sewing it onto the mammarian artery. The investigators hypothesize that using it on the mammarian artery is superior as a revascularisation technique with just as good a patency as sewing it directly onto the aorta.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

* Elective/sub acute CABG as an isolated procedure.
* Age \> 18 years
* Multi-vessel disease
* Non-dominant arm is eligible for radial artery harvest
* Written informed consent

Exclusion Criteria

* Geographically not available for follow up
* Modified Allen's test indicating insufficient ulnary artery perfusion
* Valve surgery, ablation surgery or any kind of concomitant surgery during same admission.
* Acute operation (\<24 hours from admission)
* Dialysis
* Preoperative neurological deficit on the donor arm
* LVEF \< 20% preoperative
* Former sternotomy
* Contrast allergy
* Malignant disease
* No written informed consent

Primary outcomes:
measure: Sum score of hand function questionnaire
timeFrame: 3 months postoperatively
measure: Occurence of cardiac and cerebrovascular events in aortoradial versus mammarioradial grafting
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Complications in the donor arm in ERAH versus ORAH
timeFrame: 3 months postoperatively
measure: Clinical neurological examination in donor arm ERAH versus ORAH
timeFrame: 3 months postoperatively
measure: Neurological deficits in ERAH versus ORAH
timeFrame: 3 months postoperatively
Other outcomes:
measure: Vascular function in the donor arm of the ERAH and ORAH groups compared to non-donor arms.
timeFrame: 3 months postoperatively
measure: Graft patency in ERAH versus ORAH
timeFrame: 1 year postoperatively
measure: Graft patency in aortoradial versus mammarioradial grafting
timeFrame: 1 year postoperatively
measure: Change in handgrip strength
timeFrame: the day before surgery and 1 year postoperatively.
measure: Change in muscular function in ERAH versus ORAH
timeFrame: the day before surgery and 1 year postoperatively
measure: Serious adverse events in ERAH versus ORAH
timeFrame: 1 year postoperatively
measure: Scar evaluation in ERAH versus ORAH
timeFrame: 1 year postoperatively
measure: Neuropathic pain symptoms and signs in ERAH versus ORAH
timeFrame: 3 months postoperatively
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark
name: Christian L Carranza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark
name: Peter Skov Olsen, MD DMSc
role: STUDY_CHAIR
affiliation: Copenhagen Trial Unit, Rigshospitalet, Copenhagen, Denmark
name: Christian Gluud, MD DMSc
role: STUDY_CHAIR
affiliation: Department of Clinical Neurophysiology, Rigshospitalet, Copenhagen, Denmark
name: Martin Ballegaard, MD PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, Denmark
name: Philip Hasbak, MD PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, Denmark
name: Andreas Kjær, Prof MD DMSc
role: STUDY_CHAIR
affiliation: Department of Cardiology and Radiology, Rigshospitalet, Copenhagen, Denmark
name: Klaus F Kofoed, MD DMSc
role: STUDY_CHAIR
affiliation: Multidisciplinary Pain Centre, Rigshospitalet, Copenhagen, Denmark
name: Mads Werner, MD, DMSc
role: STUDY_CHAIR
References:
citation: Carranza CL, Ballegaard M, Werner MU, Hasbak P, Kjaer A, Kofoed KF, Lindschou J, Jakobsen JC, Gluud C, Olsen PS, Steinbruchel DA. Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery: protocol for the 2 x 2 factorial designed randomised NEO trial. Trials. 2014 Apr 23;15:135. doi: 10.1186/1745-6215-15-135.