Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00054847
• Collaborator: (none)
• Enrollment: 733
• Locations: 11
• Arms: 2
• Duration (Months): 84
• Patients Per Site: 66.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

VA patients with coronary artery disease and who have agreed to undergo coronary artery bypass graft surgery would be randomized to receive either radial artery or saphenous vein to the study vessel. The primary outcome variable is graft patency at one year.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease; Coronary Artery Disease	Procedure: saphenous vein graft; Procedure: radial artery graft	N/A

Detailed Description

Primary Hypothesis:

Radial artery grafts will have a higher graft patency rate at one year after coronary artery bypass graft surgery (CABG) compared to saphenous vein grafts.

Secondary Hypotheses:

Determine if there are any differences in clinical outcomes, cost and quality of life in patients receiving radial artery versus saphenous vein grafts.

Intervention: 1) Saphenous vein graft. This is the standard conduit for coronary artery bypass grafting to all areas of the heart except the left anterior descending (LAD) artery. 2) Radial artery. This is the experimental conduit. Preference should be given to harvesting from the non-dominant arm.

Primary Outcomes: 1-year post CABG surgery patency rates

Study Abstract:

Although the radial artery was introduced as a potential conduit for coronary artery bypass grafting in the 1970s, enthusiasm for its use was limited by the technical difficulty of harvesting the vessel and problems with perioperative vascular spasm. In spite of this, some surgeons persisted based on their belief that arterial conduits would be better than vein grafts, in terms of long-term patency. With the development of new harvesting techniques and the introduction of calcium channel blockers to prevent vasospasm, the use of the radial artery graft has increased in recent years. This use of the radial artery as a conduit is not based on any long-term prospective data regarding its patency. However, because the VA has been a leader in defining the long-term efficacy/patency of saphenous vein and internal mammary grafts, it is appropriate for the VA to investigate radial artery grafts. In fact, the VA under its Cooperative Studies Program, is probably the only health care delivery system that has the ability to undertake this study.

Study Design:

The study is a prospective, randomized, unblinded clinical trial. The population consists of VA patients with coronary artery disease documented by coronary arteriography and who have agreed to undergo coronary artery bypass surgery. Medical conditions which could affect blood flow through the patient's arm are the main exclusion criteria. These include Raynaud's symptoms, positive Allen test, neurologic or musculoskeletal disease affecting the arm and patients with one arm.

Patients who are eligible and agree to participate in the study will be randomly assigned to receive one radial artery graft or one saphenous vein graft to the following vessels: left anterior descending if internal mammary not used, circumflex, diagonal, and right coronary artery. The surgeon will determine the subject vessel preoperatively by selecting the vessel that is suitable for grafting.

The stratification factors will be the participating hospital and which vessel is to be bypassed, left anterior descending versus all other vessels.

History, physical examination, laboratory tests, and cardiac catheterization will be performed at baseline and at one year. Follow-up clinic visits will be at two weeks, three, six, and nine months post CABG. Coronary angiography will be performed one week and one year post surgery. Quality of life and hand/leg functional status will be assessed at baseline, three months, and one year. Cost measures will be captured.

Biostatistical Considerations:

For this trial, a sample size of 874 randomized patients will be required. This will provide 90% power to detect a difference in one-year patency rates of 92% for the radial artery versus 83% for the saphenous vein and an expected one-year catheter completion rate of 65%.

This is a five year study. There will be four years of patient accrual and one year of follow-up. Nine participating VA medical centers will be expected to randomize two patients per month.

Study Design

• Study Type: Interventional
• Actual Enrollment: 733 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: CSP #474 - Radial Artery vs. Saphenous Vein Grafts in Coronary Artery Bypass Surgery (Radial Artery)
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Saphenous Vein Graft Saphenous Vein Graft	Procedure: saphenous vein graft; Saphenous vein harvested from the arm is used as a conduit for CABG.
Active Comparator: Radial Artery Graft Radial Artery Graft	Procedure: radial artery graft; Radial artery harvested from the arm is used as a conduit for CABG.

Outcome Measures

Primary Outcome Measures

1. To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery. [1 year]

   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.

Secondary Outcome Measures

1. Death [Within 1 year of surgery.]

2. Myocardial Infarction [Within 1 year of bypass surgery]

3. Stroke [Within 1 year of bypass surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients needing coronary artery bypass grafts.

Exclusion Criteria:

• Patients who require only a single vessel bypass and in whom the internal mammary artery will be used for that graft

• Patients with previous stripping and ligation of saphenous veins and in whom no venous conduit is available for bypass

• Patients with Raynaud's symptoms

• Patients who have a creatinine above 2.0 mg/dL or require hemodialysis

• Patients with a positive Allen test

• Patients with cardiogenic shock

• Patients who are unable to give consent

• Patients allergic to contrast material

• Patients undergoing repeat CABG or any form of robotic surgery

• Patients who do not have full use of both arms

• Patients who are pregnant

• Patients with neurologic or musculoskeletal disease affecting the arm

• Patients who refuse to participate

• Patient requires any concomitant valve operation in the mitral, aortic, or pulmonary position. Isolated tricuspid annuloplasty is acceptable, but tricuspid valve replacement excludes the patient from consideration.

• Patient requires concomitant Dor or Maze procedure

• Patient is in another research study

• No suitable radial target (there is no non-LAD vessel with a >70% stenosis)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Birmingham	Birmingham	Alabama	United States	35233
2	Southern Arizona VA Health Care System	Tucson	Arizona	United States	85723
3	Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	No. Little Rock	Arkansas	United States	72114-1706
4	Edward Hines, Jr. VA Hospital	Hines	Illinois	United States	60141-5000
5	Southeast Veterans Healthcare System, New Orleans	New Orleans	Louisiana	United States	70112
6	VA Boston Healthcare System, Brockton Campus	Brockton	Massachusetts	United States	02301
7	VA Ann Arbor Healthcare System	Ann Arbor	Michigan	United States	48113
8	VA Medical Center, Minneapolis	Minneapolis	Minnesota	United States	55417
9	New Mexico VA Health Care System, Albuquerque	Albuquerque	New Mexico	United States	87108-5153
10	Michael E. DeBakey VA Medical Center (152)	Houston	Texas	United States	77030
11	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia	United States	23249

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Study Chair: Steven Goldman, MD, Southern Arizona VA Health Care System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00054847
• Other Study ID Numbers: 474
• First Posted: Feb 13, 2003
• Last Update Posted: May 5, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by US Department of Veterans Affairs: CABG; cardiovascular; chronic diseases; clinical trial; heart; multi-site trial; prospective
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Saphenous Vein Graft	Radial Artery Graft
Arm/Group Description	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 harvested from the arm is used as a conduit for CABG.
Period Title: Overall Study
STARTED	367	366
COMPLETED	269	266
NOT COMPLETED	98	100

Baseline Characteristics

Arm/Group Title	Saphenous Vein Graft	Radial Artery Graft	Total
Arm/Group Description	Saphenous Vein Graft saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG.	Total of all reporting groups
Overall Participants	367	366	733
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (8)	61 (8)	61.6 (8.1)
Sex: Female, Male (Count of Participants)
Female	5 1.4%	1 0.3%	6 0.8%
Male	362 98.6%	365 99.7%	727 99.2%
Race/Ethnicity, Customized (participants) [Number]
White	329 89.6%	331 90.4%	660 90%
Black or African American	30 8.2%	31 8.5%	61 8.3%
Other	7 1.9%	4 1.1%	11 1.5%
Did not specify	1 0.3%	0 0%	1 0.1%
Canadian Functional Class (participants) [Number]
I	75 20.4%	79 21.6%	154 21%
II	115 31.3%	115 31.4%	230 31.4%
III	132 36%	127 34.7%	259 35.3%
IV	44 12%	44 12%	88 12%
Missing	1 0.3%	1 0.3%	2 0.3%
Target Vessel (participants) [Number]
Left Anterior Descending	53 14.4%	51 13.9%	104 14.2%
Circumflex	215 58.6%	203 55.5%	418 57%
Right Coronary Artery	99 27%	112 30.6%	211 28.8%
Comorbidities (participants) [Number]
Diabetes mellitus	153 41.7%	154 42.1%	307 41.9%
Hypertension	287 78.2%	289 79%	576 78.6%
Heart Failure	15 4.1%	28 7.7%	43 5.9%
Previous Myocardial Infarction (participants) [Number]
Previous Myocardial Infarction	143 39%	146 39.9%	289 39.4%
No Previous Myocardial Infarction	224 61%	220 60.1%	444 60.6%
Smoking History (participants) [Number]
Never smoked	49 13.4%	59 16.1%	108 14.7%
Ex-smoker	217 59.1%	220 60.1%	437 59.6%
Current smoker	99 27%	86 23.5%	185 25.2%
Missing data	2 0.5%	1 0.3%	3 0.4%
Total Cholesterol (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	177.2 (41.4)	178.8 (46.8)	177.7 (44.2)
HDL (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	39.3 (12.2)	38.5 (10.2)	38.9 (11.2)
LDL (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	105.6 (39.6)	104.2 (38.4)	104.9 (39.0)
Triglycerides (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	186.4 (118.4)	193.0 (143.6)	189.7 (131.8)

Outcome Measures

1. Primary Outcome

Title	To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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%. .

Arm/Group Title	Saphenous Vein Graft	Radial Artery Graft
Arm/Group Description	Saphenous Vein Graft saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG.
Measure Participants	269	266
Measure Coronary Artery Bypass Grafts	269	266
Number [grafts]	269	266

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Saphenous Vein Graft, Radial Artery Graft
	Comments	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%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.82
	Comments	Multiple logistic regression analysis was used to adjust for stratification factors and characteristics that were potentially predictive of graft patency. We also performed prespecified subgroup analyses and assessed treatment subgroup interaction.
	Method	Chi-squared
	Comments	We performed as-treated and per-protocol analyses & multiple imputations as sensitivity analyses to the intent-to-treat analysis on primary end point.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; .62 to 1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Death
Time Frame	Within 1 year of surgery.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saphenous Vein Graft	Radial Artery Grafts
Arm/Group Description	Saphenous Vein Graft saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery Grafts radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG.
Measure Participants	367	366
Number [participants]	7 1.9%	9 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Saphenous Vein Graft, Radial Artery Graft
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.61
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Myocardial Infarction
Time Frame	Within 1 year of bypass surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	Saphenous Vein Graft saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG.
Measure Participants	367	366
Number [participants]	5 1.4%	4 1.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Saphenous Vein Graft, Radial Artery Graft
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>.99
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Stroke
Time Frame	Within 1 year of bypass surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	Saphenous Vein Graft saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG.	Radial Artery radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG.
Measure Participants	367	366
Number [participants]	6 1.6%	7 1.9%

Adverse Events

Time Frame	From time of consent through follow-up.
Adverse Event Reporting Description	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).
Arm/Group Title	Arm 1		Arm 2
Arm/Group Description	Saphenous Vein Graft saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG.		Radial Artery radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG.
All Cause Mortality
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	172/367 (46.9%)		158/366 (43.2%)
Blood and lymphatic system disorders
Anaemia	0/367 (0%)	0	1/366 (0.3%)	1
Heparin-induced thrombocytopenia	1/367 (0.3%)	1	1/366 (0.3%)	1
Cardiac disorders
Acute myocardial infarction	1/367 (0.3%)	1	1/366 (0.3%)	1
Angina pectoris	1/367 (0.3%)	1	1/366 (0.3%)	1
Angina unstable	2/367 (0.5%)	2	2/366 (0.5%)	2
Arrhythmia	1/367 (0.3%)	1	1/366 (0.3%)	1
Arteriospasm coronary	0/367 (0%)	0	1/366 (0.3%)	1
Atrial fibrillation	11/367 (3%)	11	14/366 (3.8%)	20
Atrial flutter	2/367 (0.5%)	2	4/366 (1.1%)	4
Bradycardia	7/367 (1.9%)	7	0/366 (0%)	0
Cardiac arrest	1/367 (0.3%)	1	2/366 (0.5%)	2
Cardiac disorder	0/367 (0%)	0	1/366 (0.3%)	1
Cardiac failure	0/367 (0%)	0	1/366 (0.3%)	1
Cardiac failure congestive	6/367 (1.6%)	10	9/366 (2.5%)	14
Cardiac tamponade	1/367 (0.3%)	1	0/366 (0%)	0
Coronary artery disease	2/367 (0.5%)	2	2/366 (0.5%)	3
Coronary artery occlusion	3/367 (0.8%)	3	3/366 (0.8%)	3
Coronary artery stenosis	1/367 (0.3%)	1	2/366 (0.5%)	2
Ischaemic cardiomyopathy	1/367 (0.3%)	1	0/366 (0%)	0
Mitral valve incompetence	0/367 (0%)	0	1/366 (0.3%)	1
Myocardial infarction	3/367 (0.8%)	3	5/366 (1.4%)	6
Palpitations	1/367 (0.3%)	1	1/366 (0.3%)	1
Pericarditis	1/367 (0.3%)	1	1/366 (0.3%)	1
Tachycardia	1/367 (0.3%)	1	0/366 (0%)	0
Ventricular fibrillation	2/367 (0.5%)	2	0/366 (0%)	0
Ventricular tachycardia	2/367 (0.5%)	2	0/366 (0%)	0
Ear and labyrinth disorders
Vertigo	0/367 (0%)	0	1/366 (0.3%)	1
Gastrointestinal disorders
Abdominal hernia	0/367 (0%)	0	1/366 (0.3%)	1
Constipation	1/367 (0.3%)	1	0/366 (0%)	0
Gastric dilatation	1/367 (0.3%)	1	0/366 (0%)	0
Gastrointestinal haemorrhage	1/367 (0.3%)	1	1/366 (0.3%)	1
Haemorrhoidal haemorrhage	2/367 (0.5%)	3	0/366 (0%)	0
Oesophageal stenosis	1/367 (0.3%)	1	0/366 (0%)	0
Pancreatitis	0/367 (0%)	0	1/366 (0.3%)	1
Parotid gland inflammation	1/367 (0.3%)	1	0/366 (0%)	0
Peptic ulcer	1/367 (0.3%)	1	0/366 (0%)	0
Retroperitoneal haematoma	0/367 (0%)	0	1/366 (0.3%)	1
General disorders
Adverse drug reaction	0/367 (0%)	0	2/366 (0.5%)	2
Catheter site haematoma	1/367 (0.3%)	1	0/366 (0%)	0
Catheter site haemorrhage	1/367 (0.3%)	2	1/366 (0.3%)	1
Chest discomfort	0/367 (0%)	0	1/366 (0.3%)	1
Chest pain	19/367 (5.2%)	20	17/366 (4.6%)	18
Cyst	1/367 (0.3%)	1	0/366 (0%)	0
Death	1/367 (0.3%)	1	2/366 (0.5%)	2
Device damage	1/367 (0.3%)	1	0/366 (0%)	0
Device occlusion	0/367 (0%)	0	2/366 (0.5%)	2
General physical health deterioration	0/367 (0%)	0	1/366 (0.3%)	1
Hernia	1/367 (0.3%)	1	0/366 (0%)	0
Impaired healing	0/367 (0%)	0	1/366 (0.3%)	1
Implant site pain	0/367 (0%)	0	1/366 (0.3%)	1
Influenza like illness	1/367 (0.3%)	1	0/366 (0%)	0
Medical device complication	1/367 (0.3%)	1	0/366 (0%)	0
Multi-organ failure	0/367 (0%)	0	1/366 (0.3%)	1
Non-cardiac chest pain	1/367 (0.3%)	1	2/366 (0.5%)	2
Thrombosis in device	1/367 (0.3%)	1	0/366 (0%)	0
Unevaluable event	2/367 (0.5%)	2	0/366 (0%)	0
Hepatobiliary disorders
Bile duct obstruction	0/367 (0%)	0	1/366 (0.3%)	1
Cholecystitis	0/367 (0%)	0	2/366 (0.5%)	2
Cholelithiasis	1/367 (0.3%)	1	0/366 (0%)	0
Cholestasis	0/367 (0%)	0	1/366 (0.3%)	1
Infections and infestations
Abscess	1/367 (0.3%)	1	0/366 (0%)	0
Bronchitis	0/367 (0%)	0	1/366 (0.3%)	1
Catheter site infection	0/367 (0%)	0	1/366 (0.3%)	1
Cellulitis	3/367 (0.8%)	3	4/366 (1.1%)	4
Cellulitis streptococcal	1/367 (0.3%)	1	0/366 (0%)	0
Cholecystitis infective	1/367 (0.3%)	1	0/366 (0%)	0
Clostridium difficile colitis	0/367 (0%)	0	2/366 (0.5%)	2
Dermatitis infected	0/367 (0%)	0	1/366 (0.3%)	1
Escherichia bacteraemia	0/367 (0%)	0	1/366 (0.3%)	1
Gastroenteritis	1/367 (0.3%)	1	0/366 (0%)	0
Groin abscess	1/367 (0.3%)	1	0/366 (0%)	0
Incision site cellulitis	5/367 (1.4%)	5	2/366 (0.5%)	2
Infected dermal cyst	1/367 (0.3%)	1	0/366 (0%)	0
Infected skin ulcer	0/367 (0%)	0	1/366 (0.3%)	1
Lobar pneumonia	1/367 (0.3%)	1	0/366 (0%)	0
Localised infection	1/367 (0.3%)	1	0/366 (0%)	0
Lung infection	1/367 (0.3%)	1	0/366 (0%)	0
Mediastinitis	1/367 (0.3%)	1	0/366 (0%)	0
Pneumonia	4/367 (1.1%)	4	4/366 (1.1%)	4
Post procedural cellulitis	0/367 (0%)	0	2/366 (0.5%)	2
Post procedural infection	0/367 (0%)	0	1/366 (0.3%)	1
Post procedural pneumonia	2/367 (0.5%)	2	0/366 (0%)	0
Postoperative wound infection	14/367 (3.8%)	16	12/366 (3.3%)	14
Pyelonephritis	0/367 (0%)	0	1/366 (0.3%)	1
Sepsis	1/367 (0.3%)	1	1/366 (0.3%)	1
Upper respiratory tract infection	1/367 (0.3%)	1	0/366 (0%)	0
Urinary tract infection	1/367 (0.3%)	1	1/366 (0.3%)	1
Wound infection	1/367 (0.3%)	2	1/366 (0.3%)	1
Wound infection staphylococcal	1/367 (0.3%)	1	2/366 (0.5%)	2
Injury, poisoning and procedural complications
Arthropod bite	1/367 (0.3%)	1	1/366 (0.3%)	1
Cardiac procedure complication	4/367 (1.1%)	5	4/366 (1.1%)	4
Endotracheal intubation complication	1/367 (0.3%)	1	0/366 (0%)	0
Fall	1/367 (0.3%)	1	1/366 (0.3%)	1
Incision site haemorrhage	0/367 (0%)	0	2/366 (0.5%)	3
Incision site pain	1/367 (0.3%)	1	1/366 (0.3%)	1
Injury	0/367 (0%)	0	2/366 (0.5%)	2
Joint dislocation	1/367 (0.3%)	1	0/366 (0%)	0
Lower limb fracture	1/367 (0.3%)	1	0/366 (0%)	0
Post procedural complication	4/367 (1.1%)	4	1/366 (0.3%)	1
Post procedural haemorrhage	4/367 (1.1%)	5	3/366 (0.8%)	3
Post procedural myocardial infarction	1/367 (0.3%)	1	1/366 (0.3%)	1
Post procedural stroke	1/367 (0.3%)	1	4/366 (1.1%)	4
Postoperative respiratory failure	0/367 (0%)	0	1/366 (0.3%)	1
Postoperative thoracic procedure compli	0/367 (0%)	0	2/366 (0.5%)	2
Postoperative wound complication	1/367 (0.3%)	1	0/366 (0%)	0
Postpericardiotomy syndrome	2/367 (0.5%)	2	1/366 (0.3%)	1
Procedural pain	1/367 (0.3%)	1	0/366 (0%)	0
Road traffic accident	0/367 (0%)	0	1/366 (0.3%)	1
Seroma	0/367 (0%)	0	2/366 (0.5%)	2
Sternal fracture	0/367 (0%)	0	1/366 (0.3%)	1
Vascular graft complication	0/367 (0%)	0	1/366 (0.3%)	1
Vascular graft occlusion	4/367 (1.1%)	4	3/366 (0.8%)	4
Wound	0/367 (0%)	0	1/366 (0.3%)	1
Wound dehiscence	1/367 (0.3%)	1	0/366 (0%)	0
Investigations
Angiogram	2/367 (0.5%)	2	0/366 (0%)	0
Aspiration pleural cavity	0/367 (0%)	0	2/366 (0.5%)	2
Blood culture positive	1/367 (0.3%)	1	1/366 (0.3%)	1
Blood glucose decreased	1/367 (0.3%)	1	0/366 (0%)	0
Blood glucose increased	0/367 (0%)	0	1/366 (0.3%)	1
Catheterisation cardiac	1/367 (0.3%)	1	1/366 (0.3%)	1
Coagulation time prolonged	1/367 (0.3%)	1	0/366 (0%)	0
Colonoscopy	1/367 (0.3%)	1	0/366 (0%)	0
Device function test	2/367 (0.5%)	2	1/366 (0.3%)	1
Drug screen positive	1/367 (0.3%)	1	0/366 (0%)	0
Haemoglobin decreased	1/367 (0.3%)	1	0/366 (0%)	0
Medical observation	1/367 (0.3%)	1	0/366 (0%)	0
Platelet count decreased	1/367 (0.3%)	1	0/366 (0%)	0
Psychiatric evaluation	1/367 (0.3%)	1	0/366 (0%)	0
Transplant evaluation	1/367 (0.3%)	1	0/366 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/367 (0.3%)	1	2/366 (0.5%)	2
Diabetes mellitus inadequate control	1/367 (0.3%)	1	0/366 (0%)	0
Diabetic ketoacidosis	0/367 (0%)	0	1/366 (0.3%)	1
Fluid overload	1/367 (0.3%)	1	1/366 (0.3%)	1
Hyperglycaemia	1/367 (0.3%)	1	1/366 (0.3%)	1
Hypoglycaemia	0/367 (0%)	0	1/366 (0.3%)	1
Hypovolaemia	0/367 (0%)	0	1/366 (0.3%)	1
Musculoskeletal and connective tissue disorders
Back pain	0/367 (0%)	0	1/366 (0.3%)	1
Costochondritis	0/367 (0%)	0	1/366 (0.3%)	1
Fistula	0/367 (0%)	0	1/366 (0.3%)	1
Intervertebral disc protrusion	1/367 (0.3%)	1	0/366 (0%)	0
Muscle spasms	1/367 (0.3%)	1	0/366 (0%)	0
Musculoskeletal chest pain	1/367 (0.3%)	1	0/366 (0%)	0
Musculoskeletal pain	2/367 (0.5%)	2	0/366 (0%)	0
Rhabdomyolysis	1/367 (0.3%)	1	0/366 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma	1/367 (0.3%)	1	0/366 (0%)	0
Basal cell carcinoma	0/367 (0%)	0	2/366 (0.5%)	2
Colon cancer	0/367 (0%)	0	1/366 (0.3%)	1
Laryngeal cancer recurrent	1/367 (0.3%)	1	0/366 (0%)	0
Nervous system disorders
Carotid artery stenosis	2/367 (0.5%)	2	1/366 (0.3%)	1
Cerebral infarction	1/367 (0.3%)	1	0/366 (0%)	0
Cerebrovascular accident	6/367 (1.6%)	7	3/366 (0.8%)	3
Dizziness	0/367 (0%)	0	3/366 (0.8%)	3
Embolic stroke	0/367 (0%)	0	1/366 (0.3%)	1
Encephalopathy	0/367 (0%)	0	1/366 (0.3%)	1
Hemiparesis	1/367 (0.3%)	1	0/366 (0%)	0
Hypoaesthesia	3/367 (0.8%)	3	0/366 (0%)	0
Loss of consciousness	0/367 (0%)	0	1/366 (0.3%)	1
Neurological decompensation	0/367 (0%)	0	1/366 (0.3%)	1
Neurological symptom	0/367 (0%)	0	1/366 (0.3%)	1
Syncope	0/367 (0%)	0	1/366 (0.3%)	1
Transient ischaemic attack	1/367 (0.3%)	1	1/366 (0.3%)	1
Typical aura without headache	1/367 (0.3%)	1	0/366 (0%)	0
Psychiatric disorders
Anxiety	1/367 (0.3%)	1	0/366 (0%)	0
Claustrophobia	0/367 (0%)	0	1/366 (0.3%)	1
Delirium	0/367 (0%)	0	1/366 (0.3%)	1
Self-injurious ideation	1/367 (0.3%)	1	0/366 (0%)	0
Suicide attempt	1/367 (0.3%)	1	0/366 (0%)	0
Renal and urinary disorders
Nephrolithiasis	1/367 (0.3%)	1	1/366 (0.3%)	1
Nephropathy toxic	0/367 (0%)	0	2/366 (0.5%)	2
Renal failure acute	1/367 (0.3%)	1	3/366 (0.8%)	3
Urethral stenosis	1/367 (0.3%)	1	0/366 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	0/367 (0%)	0	1/366 (0.3%)	1
Atelectasis	1/367 (0.3%)	1	1/366 (0.3%)	1
Bronchial secretion retention	0/367 (0%)	0	1/366 (0.3%)	1
Diaphragmatic paralysis	0/367 (0%)	0	1/366 (0.3%)	1
Dyspnoea	4/367 (1.1%)	4	6/366 (1.6%)	6
Dyspnoea at rest	0/367 (0%)	0	1/366 (0.3%)	1
Mediastinal haemorrhage	2/367 (0.5%)	2	0/366 (0%)	0
Pleural effusion	11/367 (3%)	11	16/366 (4.4%)	16
Pleuritic pain	0/367 (0%)	0	1/366 (0.3%)	1
Pulmonary congestion	0/367 (0%)	0	1/366 (0.3%)	1
Pulmonary embolism	2/367 (0.5%)	2	0/366 (0%)	0
Pulmonary haemorrhage	1/367 (0.3%)	1	0/366 (0%)	0
Pulmonary mass	1/367 (0.3%)	1	0/366 (0%)	0
Respiratory disorder	0/367 (0%)	0	1/366 (0.3%)	1
Respiratory distress	0/367 (0%)	0	1/366 (0.3%)	1
Skin and subcutaneous tissue disorders
Diabetic foot	1/367 (0.3%)	1	0/366 (0%)	0
Social circumstances
Living in residential institution	0/367 (0%)	0	1/366 (0.3%)	1
Surgical and medical procedures
Angioplasty	0/367 (0%)	0	1/366 (0.3%)	1
Aortic bypass	3/367 (0.8%)	4	0/366 (0%)	0
Arterial repair	1/367 (0.3%)	1	0/366 (0%)	0
Cardiac pacemaker insertion	0/367 (0%)	0	1/366 (0.3%)	1
Carotid endarterectomy	1/367 (0.3%)	1	0/366 (0%)	0
Cholecystectomy	0/367 (0%)	0	1/366 (0.3%)	1
Colectomy	1/367 (0.3%)	1	0/366 (0%)	0
Coronary arterial stent insertion	3/367 (0.8%)	3	1/366 (0.3%)	1
Debridement	1/367 (0.3%)	1	0/366 (0%)	0
Detoxification	1/367 (0.3%)	1	0/366 (0%)	0
Drug rehabilitation	0/367 (0%)	0	1/366 (0.3%)	1
Drug therapy changed	1/367 (0.3%)	1	0/366 (0%)	0
Endarterectomy	1/367 (0.3%)	1	0/366 (0%)	0
Hospitalisation	1/367 (0.3%)	1	0/366 (0%)	0
Implantable defibrillator insertion	2/367 (0.5%)	2	4/366 (1.1%)	5
Incisional drainage	1/367 (0.3%)	1	0/366 (0%)	0
Knee arthroplasty	0/367 (0%)	0	1/366 (0.3%)	1
Leg amputation	1/367 (0.3%)	1	0/366 (0%)	0
Mechanical ventilation	2/367 (0.5%)	2	3/366 (0.8%)	3
Penile prosthesis insertion	0/367 (0%)	0	1/366 (0.3%)	1
Percutaneous coronary intervention	5/367 (1.4%)	5	4/366 (1.1%)	4
Peripheral artery angioplasty	1/367 (0.3%)	1	0/366 (0%)	0
Peripheral artery bypass	3/367 (0.8%)	3	3/366 (0.8%)	3
Peripheral revascularisation	1/367 (0.3%)	1	0/366 (0%)	0
Plastic surgery	0/367 (0%)	0	1/366 (0.3%)	1
Post procedural drainage	1/367 (0.3%)	2	0/366 (0%)	0
Splenectomy	1/367 (0.3%)	1	0/366 (0%)	0
Stent placement	1/367 (0.3%)	1	1/366 (0.3%)	1
Toe amputation	1/367 (0.3%)	1	0/366 (0%)	0
Transurethral prostatectomy	1/367 (0.3%)	1	0/366 (0%)	0
Wound drainage	3/367 (0.8%)	3	0/366 (0%)	0
Vascular disorders
Aortic aneurysm	0/367 (0%)	0	1/366 (0.3%)	1
Aortic stenosis	1/367 (0.3%)	1	0/366 (0%)	0
Arteriosclerosis	0/367 (0%)	0	1/366 (0.3%)	1
Deep vein thrombosis	3/367 (0.8%)	3	0/366 (0%)	0
Haematoma	0/367 (0%)	0	1/366 (0.3%)	1
Haemodynamic instability	0/367 (0%)	0	1/366 (0.3%)	1
Hypertensive crisis	1/367 (0.3%)	1	0/366 (0%)	0
Hypotension	2/367 (0.5%)	2	1/366 (0.3%)	1
Intermittent claudication	0/367 (0%)	0	1/366 (0.3%)	1
Peripheral artery dissection	1/367 (0.3%)	1	0/366 (0%)	0
Peripheral artery stenosis	0/367 (0%)	0	2/366 (0.5%)	2
Peripheral vascular disorder	2/367 (0.5%)	2	3/366 (0.8%)	3
Thrombophlebitis	0/367 (0%)	0	1/366 (0.3%)	1
Thrombosis	0/367 (0%)	0	1/366 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	152/367 (41.4%)		161/366 (44%)
Blood and lymphatic system disorders
Anaemia	5/367 (1.4%)	5	6/366 (1.6%)	6
Anaemia macrocytic	1/367 (0.3%)	1	0/366 (0%)	0
Leukocytosis	1/367 (0.3%)	1	2/366 (0.5%)	2
Microcytic anaemia	0/367 (0%)	0	1/366 (0.3%)	1
Pancytopenia	0/367 (0%)	0	1/366 (0.3%)	1
Thrombocytopenia	0/367 (0%)	0	2/366 (0.5%)	2
Cardiac disorders
Acute myocardial infarction	0/367 (0%)	0	1/366 (0.3%)	1
Angina pectoris	1/367 (0.3%)	1	3/366 (0.8%)	5
Angina unstable	0/367 (0%)	0	1/366 (0.3%)	1
Arrhythmia	0/367 (0%)	0	2/366 (0.5%)	2
Arrhythmia supraventricular	1/367 (0.3%)	1	1/366 (0.3%)	1
Atrial fibrillation	16/367 (4.4%)	16	15/366 (4.1%)	16
Atrial flutter	3/367 (0.8%)	3	1/366 (0.3%)	1
Bradycardia	2/367 (0.5%)	2	4/366 (1.1%)	4
Bundle branch block right	1/367 (0.3%)	1	0/366 (0%)	0
Cardiac failure	2/367 (0.5%)	2	1/366 (0.3%)	2
Cardiac failure congestive	1/367 (0.3%)	1	2/366 (0.5%)	2
Cardiac flutter	1/367 (0.3%)	1	0/366 (0%)	0
Extrasystoles	0/367 (0%)	0	2/366 (0.5%)	2
Mitral valve incompetence	0/367 (0%)	0	1/366 (0.3%)	1
Myocardial infarction	0/367 (0%)	0	1/366 (0.3%)	1
Sinus tachycardia	0/367 (0%)	0	1/366 (0.3%)	1
Supraventricular tachycardia	3/367 (0.8%)	3	0/366 (0%)	0
Tachyarrhythmia	1/367 (0.3%)	1	0/366 (0%)	0
Tachycardia	0/367 (0%)	0	1/366 (0.3%)	1
Ventricular tachycardia	1/367 (0.3%)	1	1/366 (0.3%)	1
Ear and labyrinth disorders
Ear pain	1/367 (0.3%)	1	0/366 (0%)	0
Sudden hearing loss	1/367 (0.3%)	1	0/366 (0%)	0
Vertigo	1/367 (0.3%)	1	0/366 (0%)	0
Vertigo positional	0/367 (0%)	0	1/366 (0.3%)	1
Endocrine disorders
Hyperthyroidism	0/367 (0%)	0	1/366 (0.3%)	1
Hypothyroidism	3/367 (0.8%)	3	4/366 (1.1%)	4
Eye disorders
Cataract	1/367 (0.3%)	1	2/366 (0.5%)	2
Diabetic retinopathy	1/367 (0.3%)	1	0/366 (0%)	0
Entropion	1/367 (0.3%)	1	0/366 (0%)	0
Eye allergy	0/367 (0%)	0	1/366 (0.3%)	1
Macular oedema	1/367 (0.3%)	1	0/366 (0%)	0
Optic ischaemic neuropathy	1/367 (0.3%)	2	0/366 (0%)	0
Vision blurred	0/367 (0%)	0	3/366 (0.8%)	3
Visual acuity reduced	1/367 (0.3%)	1	0/366 (0%)	0
Visual impairment	1/367 (0.3%)	1	0/366 (0%)	0
Gastrointestinal disorders
Abdominal distension	0/367 (0%)	0	1/366 (0.3%)	1
Abdominal hernia	1/367 (0.3%)	1	0/366 (0%)	0
Abdominal pain	2/367 (0.5%)	2	3/366 (0.8%)	3
Abdominal pain lower	2/367 (0.5%)	2	0/366 (0%)	0
Abdominal wall mass	1/367 (0.3%)	1	0/366 (0%)	0
Colitis	1/367 (0.3%)	1	1/366 (0.3%)	1
Constipation	0/367 (0%)	0	4/366 (1.1%)	4
Diarrhoea	2/367 (0.5%)	2	3/366 (0.8%)	3
Dyspepsia	1/367 (0.3%)	1	1/366 (0.3%)	1
Dysphagia	3/367 (0.8%)	3	2/366 (0.5%)	3
Gastritis	0/367 (0%)	0	1/366 (0.3%)	1
Haemorrhoids	0/367 (0%)	0	1/366 (0.3%)	1
Hiatus hernia	0/367 (0%)	0	1/366 (0.3%)	1
Ileus	1/367 (0.3%)	1	1/366 (0.3%)	1
Inguinal hernia	2/367 (0.5%)	2	2/366 (0.5%)	2
Intestinal obstruction	0/367 (0%)	0	1/366 (0.3%)	1
Large intestine polyp	1/367 (0.3%)	1	0/366 (0%)	0
Nausea	1/367 (0.3%)	1	1/366 (0.3%)	1
Periodontal disease	1/367 (0.3%)	1	0/366 (0%)	0
Vomiting	1/367 (0.3%)	1	0/366 (0%)	0
General disorders
Adverse drug reaction	4/367 (1.1%)	4	2/366 (0.5%)	2
Asthenia	0/367 (0%)	0	2/366 (0.5%)	2
Catheter site haematoma	1/367 (0.3%)	1	0/366 (0%)	0
Catheter site pain	1/367 (0.3%)	1	0/366 (0%)	0
Chest discomfort	4/367 (1.1%)	4	0/366 (0%)	0
Chest pain	9/367 (2.5%)	13	13/366 (3.6%)	17
Crepitations	0/367 (0%)	0	1/366 (0.3%)	1
Device breakage	1/367 (0.3%)	1	1/366 (0.3%)	1
Device occlusion	0/367 (0%)	0	1/366 (0.3%)	1
Effusion	0/367 (0%)	0	1/366 (0.3%)	1
Fatigue	0/367 (0%)	0	2/366 (0.5%)	3
Gait disturbance	0/367 (0%)	0	1/366 (0.3%)	1
Impaired healing	1/367 (0.3%)	1	0/366 (0%)	0
Infusion site extravasation	1/367 (0.3%)	1	0/366 (0%)	0
Infusion site phlebitis	0/367 (0%)	0	1/366 (0.3%)	1
Local swelling	2/367 (0.5%)	2	0/366 (0%)	0
Medical device complication	3/367 (0.8%)	3	1/366 (0.3%)	1
Oedema peripheral	1/367 (0.3%)	1	2/366 (0.5%)	2
Pain	1/367 (0.3%)	1	2/366 (0.5%)	2
Puncture site haemorrhage	1/367 (0.3%)	1	1/366 (0.3%)	1
Pyrexia	5/367 (1.4%)	5	2/366 (0.5%)	2
Swelling	1/367 (0.3%)	1	1/366 (0.3%)	2
Tenderness	1/367 (0.3%)	1	0/366 (0%)	0
Ulcer	0/367 (0%)	0	1/366 (0.3%)	1
Unevaluable event	3/367 (0.8%)	3	3/366 (0.8%)	3
Vessel puncture site haematoma	0/367 (0%)	0	1/366 (0.3%)	1
Immune system disorders
Drug hypersensitivity	1/367 (0.3%)	1	1/366 (0.3%)	1
Infections and infestations
Abscess limb	1/367 (0.3%)	1	0/366 (0%)	0
Acute sinusitis	1/367 (0.3%)	1	0/366 (0%)	0
Bronchitis	3/367 (0.8%)	3	1/366 (0.3%)	1
Candidiasis	1/367 (0.3%)	1	0/366 (0%)	0
Cellulitis	1/367 (0.3%)	1	5/366 (1.4%)	6
Coccidioidomycosis	1/367 (0.3%)	1	0/366 (0%)	0
Diverticulitis	1/367 (0.3%)	1	0/366 (0%)	0
Ear infection	0/367 (0%)	0	1/366 (0.3%)	1
Folliculitis	1/367 (0.3%)	1	0/366 (0%)	0
Fungal skin infection	0/367 (0%)	0	1/366 (0.3%)	1
Gastroenteritis	0/367 (0%)	0	1/366 (0.3%)	1
Groin abscess	1/367 (0.3%)	1	0/366 (0%)	0
Groin infection	0/367 (0%)	0	1/366 (0.3%)	1
Herpes zoster	0/367 (0%)	0	1/366 (0.3%)	1
Incision site abscess	1/367 (0.3%)	1	2/366 (0.5%)	2
Incision site cellulitis	3/367 (0.8%)	3	11/366 (3%)	12
Incision site infection	2/367 (0.5%)	2	1/366 (0.3%)	1
Infection	0/367 (0%)	0	2/366 (0.5%)	2
Influenza	1/367 (0.3%)	1	0/366 (0%)	0
Injection site infection	1/367 (0.3%)	1	0/366 (0%)	0
Localised infection	1/367 (0.3%)	1	0/366 (0%)	0
Onychomycosis	2/367 (0.5%)	2	4/366 (1.1%)	4
Otitis media acute	1/367 (0.3%)	1	0/366 (0%)	0
Pneumonia	1/367 (0.3%)	1	1/366 (0.3%)	1
Post procedural pneumonia	0/367 (0%)	0	1/366 (0.3%)	1
Postoperative wound infection	11/367 (3%)	12	12/366 (3.3%)	12
Purulent discharge	0/367 (0%)	0	2/366 (0.5%)	2
Sinusitis	1/367 (0.3%)	1	0/366 (0%)	0
Skin infection	1/367 (0.3%)	1	0/366 (0%)	0
Staphylococcal infection	0/367 (0%)	0	1/366 (0.3%)	1
Subcutaneous abscess	1/367 (0.3%)	1	0/366 (0%)	0
Tinea infection	0/367 (0%)	0	1/366 (0.3%)	1
Tooth abscess	0/367 (0%)	0	1/366 (0.3%)	1
Tooth infection	1/367 (0.3%)	1	0/366 (0%)	0
Upper respiratory tract infection	5/367 (1.4%)	5	7/366 (1.9%)	7
Urinary tract infection	6/367 (1.6%)	6	5/366 (1.4%)	5
Viral infection	2/367 (0.5%)	2	0/366 (0%)	0
Wound infection	1/367 (0.3%)	1	1/366 (0.3%)	1
Wound infection pseudomonas	0/367 (0%)	0	1/366 (0.3%)	2
Injury, poisoning and procedural complications
Anaemia postoperative	0/367 (0%)	0	2/366 (0.5%)	2
Animal bite	0/367 (0%)	0	1/366 (0.3%)	1
Ankle fracture	1/367 (0.3%)	1	0/366 (0%)	0
Anxiety postoperative	1/367 (0.3%)	1	0/366 (0%)	0
Arthropod bite	0/367 (0%)	0	1/366 (0.3%)	1
Back injury	0/367 (0%)	0	1/366 (0.3%)	1
Brachial plexus injury	1/367 (0.3%)	1	0/366 (0%)	0
Burns first degree	0/367 (0%)	0	1/366 (0.3%)	1
Cardiac procedure complication	0/367 (0%)	0	1/366 (0.3%)	1
Contusion	2/367 (0.5%)	2	0/366 (0%)	0
Corneal abrasion	0/367 (0%)	0	1/366 (0.3%)	1
Ear injury	1/367 (0.3%)	1	0/366 (0%)	0
Endotracheal intubation complication	0/367 (0%)	0	1/366 (0.3%)	1
Exposure to chemical pollution	0/367 (0%)	0	1/366 (0.3%)	1
Fall	6/367 (1.6%)	6	6/366 (1.6%)	7
Incision site complication	0/367 (0%)	0	3/366 (0.8%)	3
Incision site erythema	0/367 (0%)	0	4/366 (1.1%)	4
Incision site haematoma	1/367 (0.3%)	1	4/366 (1.1%)	4
Incision site oedema	1/367 (0.3%)	1	0/366 (0%)	0
Incision site pain	2/367 (0.5%)	2	6/366 (1.6%)	6
Incisional hernia	1/367 (0.3%)	2	0/366 (0%)	0
Laceration	0/367 (0%)	0	1/366 (0.3%)	1
Ligament sprain	0/367 (0%)	0	1/366 (0.3%)	1
Limb injury	2/367 (0.5%)	2	1/366 (0.3%)	1
Muscle strain	2/367 (0.5%)	2	0/366 (0%)	0
Peripheral nerve injury	0/367 (0%)	0	1/366 (0.3%)	1
Post procedural complication	1/367 (0.3%)	1	0/366 (0%)	0
Post procedural haemorrhage	0/367 (0%)	0	1/366 (0.3%)	1
Postoperative thoracic procedure complica	1/367 (0.3%)	1	1/366 (0.3%)	1
Postoperative wound complication	1/367 (0.3%)	1	0/366 (0%)	0
Procedural hypotension	0/367 (0%)	0	1/366 (0.3%)	1
Procedural nausea	0/367 (0%)	0	1/366 (0.3%)	1
Procedural pain	1/367 (0.3%)	1	0/366 (0%)	0
Procedural vomiting	1/367 (0.3%)	1	0/366 (0%)	0
Road traffic accident	1/367 (0.3%)	2	2/366 (0.5%)	3
Seroma	1/367 (0.3%)	1	1/366 (0.3%)	1
Stress fracture	1/367 (0.3%)	1	0/366 (0%)	0
Suture rupture	1/367 (0.3%)	1	1/366 (0.3%)	1
Tibia fracture	0/367 (0%)	0	1/366 (0.3%)	1
Tooth fracture	0/367 (0%)	0	1/366 (0.3%)	1
Vascular graft complication	0/367 (0%)	0	1/366 (0.3%)	1
Vascular graft occlusion	1/367 (0.3%)	1	0/366 (0%)	0
Wound	1/367 (0.3%)	1	1/366 (0.3%)	1
Wound dehiscence	1/367 (0.3%)	1	0/366 (0%)	0
Investigations
Biopsy kidney	0/367 (0%)	0	1/366 (0.3%)	1
Biopsy liver	0/367 (0%)	0	1/366 (0.3%)	1
Blood creatinine increased	4/367 (1.1%)	4	4/366 (1.1%)	4
Blood glucose decreased	1/367 (0.3%)	1	0/366 (0%)	0
Blood glucose increased	1/367 (0.3%)	1	1/366 (0.3%)	1
Blood potassium increased	1/367 (0.3%)	1	0/366 (0%)	0
Blood pressure increased	1/367 (0.3%)	1	0/366 (0%)	0
Body temperature increased	1/367 (0.3%)	2	0/366 (0%)	0
Breath sounds abnormal	0/367 (0%)	0	1/366 (0.3%)	1
Cardiac enzymes increased	1/367 (0.3%)	1	0/366 (0%)	0
Cardiac stress test	1/367 (0.3%)	1	0/366 (0%)	0
Cardiac stress test normal	1/367 (0.3%)	1	0/366 (0%)	0
Coagulation time prolonged	1/367 (0.3%)	1	0/366 (0%)	0
Cystoscopy	1/367 (0.3%)	1	0/366 (0%)	0
Device function test	1/367 (0.3%)	1	0/366 (0%)	0
Echocardiogram	1/367 (0.3%)	1	1/366 (0.3%)	1
Electrocardiogram ST segment elevation	0/367 (0%)	0	1/366 (0.3%)	1
Haematocrit decreased	2/367 (0.5%)	3	1/366 (0.3%)	1
Heart rate increased	0/367 (0%)	0	3/366 (0.8%)	3
Heart rate irregular	0/367 (0%)	0	1/366 (0.3%)	1
International normalised ratio increased	0/367 (0%)	0	1/366 (0.3%)	1
Ophthalmological examination	1/367 (0.3%)	1	0/366 (0%)	0
Oxygen saturation decreased	0/367 (0%)	0	3/366 (0.8%)	3
Physical examination	3/367 (0.8%)	3	2/366 (0.5%)	2
Prostatic specific antigen increased	0/367 (0%)	0	1/366 (0.3%)	1
Urine output decreased	0/367 (0%)	0	1/366 (0.3%)	1
Urological examination	0/367 (0%)	0	1/366 (0.3%)	1
Vital signs measurement	2/367 (0.5%)	2	0/366 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	1/367 (0.3%)	1	1/366 (0.3%)	1
Diabetes mellitus	0/367 (0%)	0	1/366 (0.3%)	1
Fluid overload	2/367 (0.5%)	2	3/366 (0.8%)	3
Fluid retention	0/367 (0%)	0	1/366 (0.3%)	1
Glucose tolerance impaired	1/367 (0.3%)	1	0/366 (0%)	0
Gout	2/367 (0.5%)	2	1/366 (0.3%)	1
Hyperglycaemia	8/367 (2.2%)	11	10/366 (2.7%)	13
Hyperkalaemia	0/367 (0%)	0	1/366 (0.3%)	1
Hyperlipidaemia	6/367 (1.6%)	7	2/366 (0.5%)	2
Hypernatraemia	0/367 (0%)	0	1/366 (0.3%)	1
Hypervolaemia	0/367 (0%)	0	1/366 (0.3%)	1
Hypoglycaemia	2/367 (0.5%)	2	0/366 (0%)	0
Hypokalaemia	3/367 (0.8%)	3	2/366 (0.5%)	2
Hypophosphataemia	0/367 (0%)	0	1/366 (0.3%)	1
Hypovolaemia	2/367 (0.5%)	2	1/366 (0.3%)	1
Insulin resistance	0/367 (0%)	0	1/366 (0.3%)	1
Obesity	0/367 (0%)	0	1/366 (0.3%)	1
Type 2 diabetes mellitus	0/367 (0%)	0	1/366 (0.3%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	3/367 (0.8%)	3	2/366 (0.5%)	2
Back pain	3/367 (0.8%)	5	9/366 (2.5%)	9
Bunion	1/367 (0.3%)	1	0/366 (0%)	0
Costochondritis	1/367 (0.3%)	2	0/366 (0%)	0
Flank pain	0/367 (0%)	0	1/366 (0.3%)	1
Groin pain	2/367 (0.5%)	2	0/366 (0%)	0
Intervertebral disc degeneration	0/367 (0%)	0	1/366 (0.3%)	1
Intervertebral disc protrusion	0/367 (0%)	0	1/366 (0.3%)	1
Joint range of motion decreased	1/367 (0.3%)	1	0/366 (0%)	0
Joint swelling	1/367 (0.3%)	1	0/366 (0%)	0
Lumbar spinal stenosis	0/367 (0%)	0	1/366 (0.3%)	1
Muscular weakness	1/367 (0.3%)	1	2/366 (0.5%)	2
Musculoskeletal chest pain	3/367 (0.8%)	3	6/366 (1.6%)	6
Musculoskeletal pain	6/367 (1.6%)	6	3/366 (0.8%)	3
Myalgia	0/367 (0%)	0	1/366 (0.3%)	1
Neck pain	0/367 (0%)	0	1/366 (0.3%)	1
Osteoarthritis	1/367 (0.3%)	1	2/366 (0.5%)	3
Pain in extremity	4/367 (1.1%)	4	4/366 (1.1%)	4
Rotator cuff syndrome	1/367 (0.3%)	1	1/366 (0.3%)	1
Synovial cyst	1/367 (0.3%)	1	1/366 (0.3%)	1
Tendonitis	0/367 (0%)	0	1/366 (0.3%)	1
Trigger finger	0/367 (0%)	0	1/366 (0.3%)	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	2/367 (0.5%)	2	0/366 (0%)	0
Laryngeal cancer	1/367 (0.3%)	1	0/366 (0%)	0
Prostate cancer	0/367 (0%)	0	1/366 (0.3%)	1
Nervous system disorders
Amnesia	0/367 (0%)	0	1/366 (0.3%)	1
Aphonia	0/367 (0%)	0	1/366 (0.3%)	1
Autonomic nervous system imbalance	0/367 (0%)	0	1/366 (0.3%)	1
Carotid artery stenosis	1/367 (0.3%)	1	0/366 (0%)	0
Carpal tunnel syndrome	1/367 (0.3%)	1	2/366 (0.5%)	2
Cerebrovascular accident	0/367 (0%)	0	1/366 (0.3%)	1
Cerebrovascular disorder	1/367 (0.3%)	1	0/366 (0%)	0
Dizziness	2/367 (0.5%)	2	2/366 (0.5%)	2
Dizziness exertional	1/367 (0.3%)	1	0/366 (0%)	0
Headache	3/367 (0.8%)	3	1/366 (0.3%)	1
Hypersomnia	1/367 (0.3%)	1	0/366 (0%)	0
Hypoaesthesia	9/367 (2.5%)	9	17/366 (4.6%)	19
Memory impairment	1/367 (0.3%)	1	0/366 (0%)	0
Mononeuropathy	0/367 (0%)	0	2/366 (0.5%)	2
Nerve root compression	0/367 (0%)	0	1/366 (0.3%)	1
Neuropathy peripheral	3/367 (0.8%)	3	0/366 (0%)	0
Paraesthesia	3/367 (0.8%)	3	2/366 (0.5%)	2
Peroneal nerve palsy	0/367 (0%)	0	1/366 (0.3%)	1
Polyneuropathy	1/367 (0.3%)	1	0/366 (0%)	0
Presyncope	1/367 (0.3%)	1	2/366 (0.5%)	2
Restless legs syndrome	0/367 (0%)	0	2/366 (0.5%)	4
Sensory disturbance	0/367 (0%)	0	1/366 (0.3%)	1
Syncope	2/367 (0.5%)	2	1/366 (0.3%)	1
VIIth nerve paralysis	2/367 (0.5%)	2	1/366 (0.3%)	1
Psychiatric disorders
Alcohol withdrawal syndrome	0/367 (0%)	0	1/366 (0.3%)	1
Anxiety	2/367 (0.5%)	2	1/366 (0.3%)	1
Bipolar disorder	0/367 (0%)	0	1/366 (0.3%)	1
Confusional state	1/367 (0.3%)	1	2/366 (0.5%)	2
Delirium	0/367 (0%)	0	3/366 (0.8%)	3
Depression	5/367 (1.4%)	5	7/366 (1.9%)	7
Insomnia	1/367 (0.3%)	1	4/366 (1.1%)	4
Mental status changes	1/367 (0.3%)	1	0/366 (0%)	0
Post-traumatic stress disorder	1/367 (0.3%)	1	0/366 (0%)	0
Psychotic disorder	1/367 (0.3%)	1	0/366 (0%)	0
Somnambulism	0/367 (0%)	0	1/366 (0.3%)	1
Renal and urinary disorders
Bladder obstruction	1/367 (0.3%)	1	0/366 (0%)	0
Bladder outlet obstruction	1/367 (0.3%)	1	0/366 (0%)	0
Dysuria	0/367 (0%)	0	1/366 (0.3%)	1
Haematuria	2/367 (0.5%)	2	0/366 (0%)	0
Nephropathy toxic	0/367 (0%)	0	1/366 (0.3%)	1
Pollakiuria	1/367 (0.3%)	1	0/366 (0%)	0
Renal failure	1/367 (0.3%)	1	1/366 (0.3%)	1
Renal failure acute	1/367 (0.3%)	1	3/366 (0.8%)	3
Renal failure chronic	1/367 (0.3%)	1	0/366 (0%)	0
Renal impairment	1/367 (0.3%)	1	1/366 (0.3%)	2
Renal mass	1/367 (0.3%)	1	1/366 (0.3%)	1
Urethral stenosis	2/367 (0.5%)	4	1/366 (0.3%)	1
Urinary retention	2/367 (0.5%)	3	2/366 (0.5%)	2
Reproductive system and breast disorders
Benign prostatic hyperplasia	2/367 (0.5%)	2	4/366 (1.1%)	4
Breast mass	0/367 (0%)	0	1/366 (0.3%)	1
Erectile dysfunction	1/367 (0.3%)	1	3/366 (0.8%)	3
Prostatitis	0/367 (0%)	0	1/366 (0.3%)	1
Testicular pain	0/367 (0%)	0	2/366 (0.5%)	2
Respiratory, thoracic and mediastinal disorders
Atelectasis	4/367 (1.1%)	4	3/366 (0.8%)	3
Bronchial secretion retention	1/367 (0.3%)	1	0/366 (0%)	0
Bronchitis chronic	0/367 (0%)	0	2/366 (0.5%)	2
Chronic obstructive pulmonary disease	2/367 (0.5%)	2	0/366 (0%)	0
Cough	1/367 (0.3%)	1	4/366 (1.1%)	4
Dyspnoea	3/367 (0.8%)	3	6/366 (1.6%)	7
Dyspnoea exertional	3/367 (0.8%)	3	1/366 (0.3%)	1
Emphysema	1/367 (0.3%)	1	0/366 (0%)	0
Epistaxis	1/367 (0.3%)	1	2/366 (0.5%)	2
Haemoptysis	1/367 (0.3%)	1	0/366 (0%)	0
Hypercapnia	0/367 (0%)	0	1/366 (0.3%)	1
Hypoventilation	0/367 (0%)	0	1/366 (0.3%)	1
Hypoxia	5/367 (1.4%)	5	5/366 (1.4%)	6
Lung infiltration	1/367 (0.3%)	1	1/366 (0.3%)	1
Pleural effusion	12/367 (3.3%)	13	13/366 (3.6%)	14
Pleurisy	0/367 (0%)	0	1/366 (0.3%)	1
Pleuritic pain	2/367 (0.5%)	2	1/366 (0.3%)	1
Pneumothorax	1/367 (0.3%)	1	3/366 (0.8%)	3
Pulmonary congestion	0/367 (0%)	0	1/366 (0.3%)	1
Pulmonary fibrosis	1/367 (0.3%)	1	0/366 (0%)	0
Pulmonary hypertension	0/367 (0%)	0	1/366 (0.3%)	1
Pulmonary mass	1/367 (0.3%)	1	0/366 (0%)	0
Pulmonary oedema	1/367 (0.3%)	1	2/366 (0.5%)	2
Rales	1/367 (0.3%)	1	1/366 (0.3%)	1
Respiratory depth decreased	0/367 (0%)	0	1/366 (0.3%)	1
Sinus congestion	1/367 (0.3%)	1	0/366 (0%)	0
Sleep apnoea syndrome	2/367 (0.5%)	2	0/366 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	0/367 (0%)	0	1/366 (0.3%)	1
Decubitus ulcer	2/367 (0.5%)	2	0/366 (0%)	0
Dermal cyst	1/367 (0.3%)	1	0/366 (0%)	0
Dermatitis	0/367 (0%)	0	1/366 (0.3%)	1
Dermatitis contact	1/367 (0.3%)	1	1/366 (0.3%)	1
Diabetic foot	1/367 (0.3%)	1	0/366 (0%)	0
Drug eruption	0/367 (0%)	0	1/366 (0.3%)	1
Ingrowing nail	1/367 (0.3%)	1	1/366 (0.3%)	1
Keloid scar	1/367 (0.3%)	1	0/366 (0%)	0
Nail discolouration	0/367 (0%)	0	1/366 (0.3%)	1
Rash	2/367 (0.5%)	2	3/366 (0.8%)	3
Scar pain	1/367 (0.3%)	1	0/366 (0%)	0
Skin disorder	1/367 (0.3%)	1	0/366 (0%)	0
Skin lesion	1/367 (0.3%)	1	0/366 (0%)	0
Skin ulcer	0/367 (0%)	0	1/366 (0.3%)	1
Social circumstances
Physical assault	1/367 (0.3%)	1	0/366 (0%)	0
Surgical and medical procedures
Arthrectomy	1/367 (0.3%)	1	0/366 (0%)	0
Cardiac pacemaker insertion	0/367 (0%)	0	1/366 (0.3%)	1
Catheter removal	1/367 (0.3%)	1	0/366 (0%)	0
Debridement	0/367 (0%)	0	2/366 (0.5%)	2
Elective procedure	1/367 (0.3%)	1	0/366 (0%)	0
Implantable defibrillator insertion	0/367 (0%)	0	1/366 (0.3%)	1
Incisional drainage	2/367 (0.5%)	2	2/366 (0.5%)	2
Influenza immunisation	1/367 (0.3%)	1	0/366 (0%)	0
Joint arthroplasty	1/367 (0.3%)	1	1/366 (0.3%)	1
Joint injection	1/367 (0.3%)	1	0/366 (0%)	0
Patient restraint	0/367 (0%)	0	1/366 (0.3%)	1
Peripheral artery bypass	1/367 (0.3%)	1	0/366 (0%)	0
Post procedural drainage	1/367 (0.3%)	1	0/366 (0%)	0
Suture removal	1/367 (0.3%)	1	0/366 (0%)	0
Transfusion	1/367 (0.3%)	2	0/366 (0%)	0
Wound drainage	0/367 (0%)	0	1/366 (0.3%)	1
Vascular disorders
Angiopathy	1/367 (0.3%)	1	0/366 (0%)	0
Deep vein thrombosis	0/367 (0%)	0	1/366 (0.3%)	1
Haematoma	1/367 (0.3%)	1	1/366 (0.3%)	1
Hypertension	11/367 (3%)	13	9/366 (2.5%)	10
Hypotension	5/367 (1.4%)	5	4/366 (1.1%)	4
Iliac artery occlusion	0/367 (0%)	0	1/366 (0.3%)	1
Intermittent claudication	4/367 (1.1%)	4	1/366 (0.3%)	1
Orthostatic hypotension	1/367 (0.3%)	1	1/366 (0.3%)	1
Peripheral vascular disorder	1/367 (0.3%)	1	0/366 (0%)	0
Systolic hypertension	1/367 (0.3%)	1	0/366 (0%)	0
Thrombophlebitis	1/367 (0.3%)	1	1/366 (0.3%)	1

Limitations/Caveats

There was more disease in the radial artery grafts at 1 week and at 1 year. There is more spasm or string sign in radial artery grafts. Study was conducted predominantly in men. Data show lower vein graft patency when endoscopic harvesting was used.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.