Trial Outcomes & Findings for Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery (NCT NCT00054847)

Last Updated: 2014-05-05

Results Overview

The primary end point was angiographic graft patency at 1 year after coronary artery bypass surgery, defined as any opacification of distal target by injection of the graft. The window for the 1-year angiogram was 2 to 24 months. This window was chosen to capture early clinically indicated angiograms and late selective angiograms in patients who did not have symptoms. Study grafts that were occluded at 1 week after coronary artery bypass graft surgery were considered occluded at 1 year. One-year graft patency data were missing if patients whose study grafts were patent at 1 week did not undergo an angiogram within the time window or if the central angiography laboratory was not able to determine graft patency.

Recruitment status

COMPLETED

Study phase

Target enrollment

733 participants

Primary outcome timeframe

1 year

Results posted on

2014-05-05

Participant Flow

Multicenter, randomized controlled trial conducted from February 2003 to February 2009 at 11 Veterans Affairs medical centers among 757 participants (99% men) undergoing first-time elective coronary artery bypass graft surgery.

The left internal mammary artery was used to preferentially graft the left anterior descending coronary artery whenever possible; the best remaining recipient vessel was randomized to radial artery vs saphenous vein graft.

Participant milestones

Participant milestones
Measure	Saphenous Vein Graft Saphenous Vein Graft saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery Graft Radial Artery Graft radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG.
Overall Study STARTED	367	366
Overall Study COMPLETED	269	266
Overall Study NOT COMPLETED	98	100

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saphenous Vein Graft n=367 Participants Saphenous Vein Graft saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery Graft n=366 Participants Radial Artery radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG.	Total n=733 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 8 • n=99 Participants	61 years STANDARD_DEVIATION 8 • n=107 Participants	61.6 years STANDARD_DEVIATION 8.1 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	1 Participants n=107 Participants	6 Participants n=206 Participants
Sex: Female, Male Male	362 Participants n=99 Participants	365 Participants n=107 Participants	727 Participants n=206 Participants
Race/Ethnicity, Customized White	329 participants n=99 Participants	331 participants n=107 Participants	660 participants n=206 Participants
Race/Ethnicity, Customized Black or African American	30 participants n=99 Participants	31 participants n=107 Participants	61 participants n=206 Participants
Race/Ethnicity, Customized Other	7 participants n=99 Participants	4 participants n=107 Participants	11 participants n=206 Participants
Race/Ethnicity, Customized Did not specify	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Canadian Functional Class I	75 participants n=99 Participants	79 participants n=107 Participants	154 participants n=206 Participants
Canadian Functional Class II	115 participants n=99 Participants	115 participants n=107 Participants	230 participants n=206 Participants
Canadian Functional Class III	132 participants n=99 Participants	127 participants n=107 Participants	259 participants n=206 Participants
Canadian Functional Class IV	44 participants n=99 Participants	44 participants n=107 Participants	88 participants n=206 Participants
Canadian Functional Class Missing	1 participants n=99 Participants	1 participants n=107 Participants	2 participants n=206 Participants
Target Vessel Left Anterior Descending	53 participants n=99 Participants	51 participants n=107 Participants	104 participants n=206 Participants
Target Vessel Circumflex	215 participants n=99 Participants	203 participants n=107 Participants	418 participants n=206 Participants
Target Vessel Right Coronary Artery	99 participants n=99 Participants	112 participants n=107 Participants	211 participants n=206 Participants
Comorbidities Diabetes mellitus	153 participants n=99 Participants	154 participants n=107 Participants	307 participants n=206 Participants
Comorbidities Hypertension	287 participants n=99 Participants	289 participants n=107 Participants	576 participants n=206 Participants
Comorbidities Heart Failure	15 participants n=99 Participants	28 participants n=107 Participants	43 participants n=206 Participants
Previous Myocardial Infarction Previous Myocardial Infarction	143 participants n=99 Participants	146 participants n=107 Participants	289 participants n=206 Participants
Previous Myocardial Infarction No Previous Myocardial Infarction	224 participants n=99 Participants	220 participants n=107 Participants	444 participants n=206 Participants
Smoking History Never smoked	49 participants n=99 Participants	59 participants n=107 Participants	108 participants n=206 Participants
Smoking History Ex-smoker	217 participants n=99 Participants	220 participants n=107 Participants	437 participants n=206 Participants
Smoking History Current smoker	99 participants n=99 Participants	86 participants n=107 Participants	185 participants n=206 Participants
Smoking History Missing data	2 participants n=99 Participants	1 participants n=107 Participants	3 participants n=206 Participants
Total Cholesterol	177.2 mg/dL STANDARD_DEVIATION 41.4 • n=99 Participants	178.8 mg/dL STANDARD_DEVIATION 46.8 • n=107 Participants	177.7 mg/dL STANDARD_DEVIATION 44.2 • n=206 Participants
HDL	39.3 mg/dL STANDARD_DEVIATION 12.2 • n=99 Participants	38.5 mg/dL STANDARD_DEVIATION 10.2 • n=107 Participants	38.9 mg/dL STANDARD_DEVIATION 11.2 • n=206 Participants
LDL	105.6 mg/dL STANDARD_DEVIATION 39.6 • n=99 Participants	104.2 mg/dL STANDARD_DEVIATION 38.4 • n=107 Participants	104.9 mg/dL STANDARD_DEVIATION 39.0 • n=206 Participants
Triglycerides	186.4 mg/dL STANDARD_DEVIATION 118.4 • n=99 Participants	193.0 mg/dL STANDARD_DEVIATION 143.6 • n=107 Participants	189.7 mg/dL STANDARD_DEVIATION 131.8 • n=206 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All analyses were performed according to intention to treat. The study was designed to have 90%power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5% and an expected 1-year catheterization completion rate of 65%. .

Outcome measures

Outcome measures
Measure	Saphenous Vein Graft n=269 Coronary Artery Bypass Grafts Saphenous Vein Graft saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery Graft n=266 Coronary Artery Bypass Grafts Radial Artery radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG.
To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.	269 grafts	266 grafts

SECONDARY outcome

Timeframe: Within 1 year of surgery.

Outcome measures

Outcome measures
Measure	Saphenous Vein Graft n=367 Participants Saphenous Vein Graft saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery Graft n=366 Participants Radial Artery radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG.
Death	7 participants	9 participants

SECONDARY outcome

Timeframe: Within 1 year of bypass surgery

Outcome measures

Outcome measures
Measure	Saphenous Vein Graft n=367 Participants Saphenous Vein Graft saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery Graft n=366 Participants Radial Artery radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG.
Myocardial Infarction	5 participants	4 participants

SECONDARY outcome

Timeframe: Within 1 year of bypass surgery

Outcome measures

Outcome measures
Measure	Saphenous Vein Graft n=367 Participants Saphenous Vein Graft saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery Graft n=366 Participants Radial Artery radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG.
Stroke	6 participants	7 participants

Adverse Events

Arm 1

Serious events: 172 serious events

Other events: 152 other events

Deaths: 0 deaths

Arm 2

Serious events: 158 serious events

Other events: 161 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Steven Goldman, MD

Southern Arizona VA Health Care System

Phone: (520) 792-1450

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Arm 1 n=367 participants at risk Saphenous Vein Graft saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG.	Arm 2 n=366 participants at risk Radial Artery radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG.
Surgical and medical procedures Percutaneous coronary intervention	1.4% 5/367 • Number of events 5 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	1.1% 4/366 • Number of events 4 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Pericarditis	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Surgical and medical procedures Peripheral artery angioplasty	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Abdominal hernia	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Abscess	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Acute myocardial infarction	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Adverse drug reaction	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Blood and lymphatic system disorders Anaemia	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Angina pectoris	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Angina unstable	0.54% 2/367 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Investigations Angiogram	0.54% 2/367 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Surgical and medical procedures Angioplasty	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Psychiatric disorders Anxiety	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Aortic aneurysm	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Surgical and medical procedures Aortic bypass	0.82% 3/367 • Number of events 4 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Aortic stenosis	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Arrhythmia	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Surgical and medical procedures Arterial repair	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Arteriosclerosis	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Arteriospasm coronary	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Arthropod bite	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Investigations Aspiration pleural cavity	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Atrial fibrillation	3.0% 11/367 • Number of events 11 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	3.8% 14/366 • Number of events 20 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Atrial flutter	0.54% 2/367 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	1.1% 4/366 • Number of events 4 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Hepatobiliary disorders Bile duct obstruction	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Investigations Blood culture positive	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Investigations Blood glucose decreased	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Investigations Blood glucose increased	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Bradycardia	1.9% 7/367 • Number of events 7 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Bronchitis	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac arrest	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac disorder	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac failure	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac failure congestive	1.6% 6/367 • Number of events 10 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	2.5% 9/366 • Number of events 14 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).

Other adverse events
Measure	Arm 1 n=367 participants at risk Saphenous Vein Graft saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG.	Arm 2 n=366 participants at risk Radial Artery radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Cardiac procedure complication	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Burns first degree	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Candidiasis	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Investigations Cardiac enzymes increased	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac failure	0.54% 2/367 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac failure congestive	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Investigations Cardiac stress test	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Abdominal distension	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Abdominal hernia	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Abdominal pain	0.54% 2/367 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.82% 3/366 • Number of events 3 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac flutter	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Abdominal pain lower	0.54% 2/367 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Abdominal wall mass	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Abscess limb	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Acute myocardial infarction	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Acute sinusitis	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Adverse drug reaction	1.1% 4/367 • Number of events 4 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Amnesia	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Blood and lymphatic system disorders Anaemia	1.4% 5/367 • Number of events 5 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	1.6% 6/366 • Number of events 6 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Blood and lymphatic system disorders Anaemia macrocytic	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Angina pectoris	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.82% 3/366 • Number of events 5 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Angina unstable	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Angiopathy	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Animal bite	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Ankle fracture	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Psychiatric disorders Anxiety	0.54% 2/367 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Anxiety postoperative	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Aphonia	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Arrhythmia	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Arrhythmia supraventricular	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Arthralgia	0.82% 3/367 • Number of events 3 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Surgical and medical procedures Arthrectomy	0.27% 1/367 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/366 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 1/366 • Number of events 1 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Asthenia	0.00% 0/367 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 2/366 • Number of events 2 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Atelectasis	1.1% 4/367 • Number of events 4 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.82% 3/366 • Number of events 3 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Atrial fibrillation	4.4% 16/367 • Number of events 16 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	4.1% 15/366 • Number of events 16 • From time of consent through follow-up. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).