REGROUP: Randomized Endo-Vein Graft Prospective
Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01850082
Collaborator
(none)
1,150
16
2
85
71.9
0.8
Study Details
Study Description
Brief Summary
Coronary artery bypass grafting (CABG) is the most common major surgical procedure in the United States with over 300,000 cases performed each year. To restore blood flow to the heart, vascular conduits from another part of the body are procured to create a bypass around critically blocked coronary arteries. The left internal thoracic artery is the conduit of choice for CABG due to its superior long-term patency. However, almost all patients referred for CABG require additional grafts to provide complete revascularization. This necessitates the harvest of other vessels, most commonly the saphenous vein which is used almost ubiquitously in contemporary CABG with an average of two vein grafts per CABG procedure. In the last 10 years, Endoscopic Vein Harvesting (EVH) has been recommended as the preferred method over the traditional open harvesting technique (OVH) because it provides a minimally invasive approach. However, more recent investigations indicate potential for reduced long-term bypass graft patency and worse clinical outcomes with EVH. The long term impact of EVH on clinical outcomes has never been investigated on a large scale using a definitive, adequately powered, prospective Randomized Controlled Trial (RCT) with long-term follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
CSP #588 - REGROUP is a randomized, intent-to-treat, two-arm, parallel design, multicenter study. Cardiac Surgery Programs at Veterans Affairs Medical Centers (VAMC) with expertise in performing both EVH and OVH will be invited to participate in the study. Subjects requiring elective or urgent CABG using cardiopulmonary bypass with use of at least one SVG will be screened for enrollment using established inclusion/exclusion criteria. Enrolled Subjects will be randomized to one of the two arms (EVH or OVH) after an experienced vein harvester is identified and assigned. Intraoperative assessments will be collected and post-operative assessments will be completed 24 hours post-surgery. Additional assessments will be completed at the time of discharge or at the 30-day post-surgery date if the subject is still in the hospital. Assessment of leg wound complications will be completed at the time of discharge and at six-week post-surgery. Telephone follow-ups will occur at three-month interval post-surgery until the participating sites are decommissioned at the end of the trial period (which would be approximately 4.5 years after the site initiations). For long-term MACE outcomes, passive follow up for MACE events using VA databases (CPRS, VASQIP) will be performed centrally by the Study Chair's office for another 2 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CSP #588 - Randomized Endo-Vein Graft Prospective (REGROUP) Trial
Actual Study Start Date
:
Sep 30, 2013
Actual Primary Completion Date
:
Sep 30, 2020
Actual Study Completion Date
:
Oct 30, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Endoscopic Vein Harvest (EVH) An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length. |
Procedure: Vein Harvesting Procedures
Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH.
|
| Other: Open Vein Harvest (OVH) Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as "bridging" technique) along the course of the vein. |
Procedure: Vein Harvesting Procedures
Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH.
|
Outcome Measures
Primary Outcome Measures
- Incidence of First MACE During Active Follow-up Period. [Varying timeframe for each participant with a minimum of 1 year and a maximum 4.5 Years]
Incidence of first MACE estimated via Kaplan Meier survival analysis (MACE defined as death from any cause, repeat revascularization, myocardial infarction) during the active follow-up period.
Secondary Outcome Measures
- MACE at One Year. [1 year]
Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at one year postoperatively.
- MACE at Three Years. [3 years]
Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at three years postoperatively.
- Incidence of First MACE Over the Entire Follow-up Period (Active and Passive). [Varying timeframe for each participant with a minimum of 3 years and a maximum of 6.5 years]
Incidence of first MACE estimated via Kaplan Meier survival analysis (MACE defined as death from any cause, repeat revascularization, myocardial infarction) during the entire follow-up period (active and passive).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age years 18 years or older
-
Elective or Urgent CABG-only
-
Median sternotomy approach
-
At least one coronary bypass planned using saphenous vein graft for conduit
-
Experienced EVH/OVH harvester available for procedure
Exclusion Criteria:
-
Combined valve procedure planned
-
Moderate or severe valve disease (see definition of moderate/severe valve)
-
Hemodynamically unstable or in cardiogenic shock
-
Enrolled in another therapeutic or interventional study
-
Off-pump CABG procedure planned
-
Limited life expectancy < 1 year
-
History of lower extremities venous stripping or ligation
-
Inability to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern Arizona VA Health Care System, Tucson, AZ | Tucson | Arizona | United States | 85723 |
| 2 | San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | United States | 94121 |
| 3 | North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida | United States | 32608 |
| 4 | Miami VA Healthcare System, Miami, FL | Miami | Florida | United States | 33125 |
| 5 | James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida | United States | 33612 |
| 6 | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | United States | 02130 |
| 7 | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | United States | 55417 |
| 8 | New Mexico VA Health Care System, Albuquerque, NM | Albuquerque | New Mexico | United States | 87108-5153 |
| 9 | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | United States | 10010 |
| 10 | Asheville VA Medical Center, Asheville, NC | Asheville | North Carolina | United States | 28805 |
| 11 | Durham VA Medical Center, Durham, NC | Durham | North Carolina | United States | 27705 |
| 12 | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | United States | 44106 |
| 13 | VA Portland Health Care System, Portland, OR | Portland | Oregon | United States | 97239 |
| 14 | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | United States | 15240 |
| 15 | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | United States | 77030 |
| 16 | Clement J. Zablocki VA Medical Center, Milwaukee, WI | Milwaukee | Wisconsin | United States | 53295-1000 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Study Chair: Marco A Zenati, MD MSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01850082
Other Study ID Numbers:
- 588
First Posted:
May 9, 2013
Last Update Posted:
Dec 15, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) |
|---|---|---|
| Arm/Group Description | An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. | Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as "bridging" technique) along the course of the vein. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. |
| Period Title: Overall Study | ||
| STARTED | 576 | 574 |
| COMPLETED | 576 | 574 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) | Total |
|---|---|---|---|
| Arm/Group Description | An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. | Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as "bridging" technique) along the course of the vein. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. | Total of all reporting groups |
| Overall Participants | 576 | 574 | 1150 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
66.2
(6.7)
|
66.6
(7.1)
|
66.4
(6.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
4
0.7%
|
3
0.5%
|
7
0.6%
|
| Male |
572
99.3%
|
571
99.5%
|
1143
99.4%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| American Indian or Alaskan Native |
4
0.7%
|
2
0.3%
|
6
0.5%
|
| Asian or Pacific Islander |
6
1%
|
4
0.7%
|
10
0.9%
|
| Black, not of Hispanic origin |
41
7.1%
|
50
8.7%
|
91
7.9%
|
| Hispanic |
31
5.4%
|
31
5.4%
|
62
5.4%
|
| , not of Hispanic origin |
490
85.1%
|
484
84.3%
|
974
84.7%
|
| Other |
3
0.5%
|
3
0.5%
|
6
0.5%
|
| Missing |
1
0.2%
|
0
0%
|
1
0.1%
|
Outcome Measures
| Title | Incidence of First MACE During Active Follow-up Period. |
|---|---|
| Description | Incidence of first MACE estimated via Kaplan Meier survival analysis (MACE defined as death from any cause, repeat revascularization, myocardial infarction) during the active follow-up period. |
| Time Frame | Varying timeframe for each participant with a minimum of 1 year and a maximum 4.5 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Events captured during the active follow-up phase of the trial (minimum of 1 year and up to 4.5 years) were included in this analysis. |
| Arm/Group Title | Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) |
|---|---|---|
| Arm/Group Description | An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. | Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as "bridging" technique) along the course of the vein. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. |
| Measure Participants | 576 | 574 |
| Count of Participants [Participants] |
80
13.9%
|
89
15.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Endoscopic Vein Harvest (EVH) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.47 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.12 | |
| Confidence Interval |
(2-Sided) 95% 0.83 to 1.51 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | MACE at One Year. |
|---|---|
| Description | Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at one year postoperatively. |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with a minimum of 1 year follow-up or who died within one year. |
| Arm/Group Title | Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) |
|---|---|---|
| Arm/Group Description | An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. | Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as "bridging" technique) along the course of the vein. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. |
| Measure Participants | 571 | 570 |
| Count of Participants [Participants] |
45
7.8%
|
47
8.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Endoscopic Vein Harvest (EVH), Open Vein Harvest (OVH) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.821 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | MACE at Three Years. |
|---|---|
| Description | Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at three years postoperatively. |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with a minimum of 3 years follow-up or died prior to 3 years. |
| Arm/Group Title | Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) |
|---|---|---|
| Arm/Group Description | An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. | Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as "bridging" technique) along the course of the vein. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. |
| Measure Participants | 568 | 568 |
| Count of Participants [Participants] |
90
15.6%
|
90
15.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Endoscopic Vein Harvest (EVH), Open Vein Harvest (OVH) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.99 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Incidence of First MACE Over the Entire Follow-up Period (Active and Passive). |
|---|---|
| Description | Incidence of first MACE estimated via Kaplan Meier survival analysis (MACE defined as death from any cause, repeat revascularization, myocardial infarction) during the entire follow-up period (active and passive). |
| Time Frame | Varying timeframe for each participant with a minimum of 3 years and a maximum of 6.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Events captured throughout active and passive follow-up are included in this analysis. |
| Arm/Group Title | Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) |
|---|---|---|
| Arm/Group Description | An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. | Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as "bridging" technique) along the course of the vein. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. |
| Measure Participants | 576 | 574 |
| Count of Participants [Participants] |
126
21.9%
|
135
23.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Endoscopic Vein Harvest (EVH), Open Vein Harvest (OVH) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.517 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.923 | |
| Confidence Interval |
(2-Sided) 95% 0.724 to 1.176 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Participant adverse event data collection stopped at the end of active follow-up. All participants had a minimum of 1 year of SAE reporting with a maximum duration of 4 years 7 months, depending on participants' time of termination from active follow-up. However, all cause mortality was collected through passive follow-up (6.5 years). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Only Serious Adverse Events were collected. Collection of SAE's occurred through routine inquiry by Site Investigator every 3 months at study visits/phone call assessments. | |||
| Arm/Group Title | Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) | ||
| Arm/Group Description | An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. | Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as "bridging" technique) along the course of the vein. Vein Harvesting Procedures: Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. | ||
All Cause Mortality |
||||
| Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 69/576 (12%) | 76/574 (13.2%) | ||
Serious Adverse Events |
||||
| Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 366/576 (63.5%) | 359/574 (62.5%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Coagulopathy | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Haemorrhagic disorder | 0/576 (0%) | 0 | 0/574 (0%) | 0 |
| Heparin-induced thrombocytopenia | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Immune thrombocytopenic purpura | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Iron deficiency anaemia | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Leukocytosis | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Lymphadenopathy | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Pancytopenia | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Splenic haematoma | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Thrombocytopenia | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Cardiac disorders | ||||
| Acute coronary syndrome | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Acute left ventricular failure | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Angina pectoris | 8/576 (1.4%) | 8 | 8/574 (1.4%) | 11 |
| Angina unstable | 3/576 (0.5%) | 3 | 6/574 (1%) | 7 |
| Aortic valve stenosis | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Arrhythmia | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Arteriosclerosis coronary artery | 3/576 (0.5%) | 3 | 0/574 (0%) | 0 |
| Atrial fibrillation | 25/576 (4.3%) | 30 | 31/574 (5.4%) | 36 |
| Atrial flutter | 15/576 (2.6%) | 16 | 3/574 (0.5%) | 3 |
| Atrial tachycardia | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Atrioventricular block | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Atrioventricular block complete | 4/576 (0.7%) | 4 | 3/574 (0.5%) | 3 |
| Atrioventricular block first degree | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Atrioventricular block second degree | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Bradycardia | 3/576 (0.5%) | 3 | 4/574 (0.7%) | 5 |
| Cardiac arrest | 3/576 (0.5%) | 3 | 2/574 (0.3%) | 2 |
| Cardiac failure | 6/576 (1%) | 6 | 9/574 (1.6%) | 12 |
| Cardiac failure acute | 4/576 (0.7%) | 4 | 4/574 (0.7%) | 5 |
| Cardiac failure congestive | 41/576 (7.1%) | 53 | 25/574 (4.4%) | 50 |
| Cardiac perforation | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Cardiac tamponade | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Cardiogenic shock | 2/576 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Cardiomyopathy | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Cor pulmonale | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Coronary artery disease | 23/576 (4%) | 26 | 30/574 (5.2%) | 34 |
| Coronary artery occlusion | 2/576 (0.3%) | 2 | 7/574 (1.2%) | 7 |
| Coronary artery stenosis | 8/576 (1.4%) | 8 | 5/574 (0.9%) | 6 |
| Coronary ostial stenosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Defect conduction intraventricular | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Intracardiac thrombus | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Ischaemic cardiomyopathy | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Left ventricular dysfunction | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Left ventricular failure | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Mitral valve incompetence | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Myocardial infarction | 27/576 (4.7%) | 28 | 30/574 (5.2%) | 34 |
| Myocardial ischaemia | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Nodal rhythm | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Palpitations | 3/576 (0.5%) | 3 | 0/574 (0%) | 0 |
| Papillary muscle rupture | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Pericardial effusion | 5/576 (0.9%) | 5 | 5/574 (0.9%) | 9 |
| Pericardial haemorrhage | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Pericarditis | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 3 |
| Pericarditis uraemic | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Pulseless electrical activity | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Right ventricular failure | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Sinus arrest | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Sinus node dysfunction | 3/576 (0.5%) | 3 | 0/574 (0%) | 0 |
| Supraventricular tachycardia | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Tachycardia | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Ventricular arrhythmia | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Ventricular asystole | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Ventricular extrasystoles | 2/576 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Ventricular fibrillation | 3/576 (0.5%) | 4 | 4/574 (0.7%) | 4 |
| Ventricular tachycardia | 4/576 (0.7%) | 5 | 4/574 (0.7%) | 4 |
| Ear and labyrinth disorders | ||||
| Meniere's disease | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Vertigo | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Endocrine disorders | ||||
| Adrenocortical insufficiency acute | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Hyperthyroidism | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Thyroid disorder | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Eye disorders | ||||
| Diplopia | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Endocrine ophthalmopathy | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Optic ischaemic neuropathy | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Retinal detachment | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal distension | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Abdominal hernia | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Abdominal pain | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Abdominal wall haematoma | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Anal stenosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Colitis | 0/576 (0%) | 0 | 4/574 (0.7%) | 4 |
| Colitis ischaemic | 1/576 (0.2%) | 2 | 1/574 (0.2%) | 1 |
| Colonic pseudo-obstruction | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Constipation | 2/576 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Diarrhoea | 2/576 (0.3%) | 2 | 3/574 (0.5%) | 3 |
| Dieulafoy's vascular malformation | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Diverticulum | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Diverticulum intestinal haemorrhagic | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Duodenal ulcer haemorrhage | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Dysphagia | 2/576 (0.3%) | 2 | 3/574 (0.5%) | 3 |
| Enteritis | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Enterocolitis | 0/576 (0%) | 0 | 1/574 (0.2%) | 2 |
| Enterocutaneous fistula | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Epiploic appendagitis | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Food poisoning | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Gastric ulcer | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Gastric ulcer haemorrhage | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Gastritis | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Gastritis erosive | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Gastrointestinal haemorrhage | 4/576 (0.7%) | 4 | 2/574 (0.3%) | 2 |
| Gastrointestinal polyp haemorrhage | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Gastrooesophageal reflux disease | 2/576 (0.3%) | 2 | 5/574 (0.9%) | 5 |
| Haemorrhoidal haemorrhage | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Ileus | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Inguinal hernia | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Intestinal obstruction | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Intestinal perforation | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Large intestinal stenosis | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Large intestinal ulcer haemorrhage | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Large intestine perforation | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Lower gastrointestinal haemorrhage | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Mallory-Weiss syndrome | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Melaena | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Obstruction gastric | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Oesophageal perforation | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Oesophageal stenosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Oesophageal ulcer | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Oral disorder | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Pancreatitis | 1/576 (0.2%) | 3 | 2/574 (0.3%) | 2 |
| Pancreatitis acute | 3/576 (0.5%) | 3 | 1/574 (0.2%) | 1 |
| Rectal haemorrhage | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Salivary gland cyst | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Small intestinal obstruction | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Umbilical hernia | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Varices oesophageal | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Vomiting | 3/576 (0.5%) | 3 | 2/574 (0.3%) | 2 |
| General disorders | ||||
| Adverse drug reaction | 0/576 (0%) | 0 | 3/574 (0.5%) | 4 |
| Asthenia | 3/576 (0.5%) | 3 | 2/574 (0.3%) | 2 |
| Brain death | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Cardiac death | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Catheter site haematoma | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Chest discomfort | 4/576 (0.7%) | 4 | 1/574 (0.2%) | 1 |
| Chest pain | 23/576 (4%) | 24 | 28/574 (4.9%) | 34 |
| Complication associated with device | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Complication of device removal | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Death | 4/576 (0.7%) | 4 | 3/574 (0.5%) | 3 |
| Device related thrombosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Drug withdrawal syndrome | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Impaired healing | 0/576 (0%) | 0 | 3/574 (0.5%) | 3 |
| Ischaemic ulcer | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Multiple organ dysfunction syndrome | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Non-cardiac chest pain | 11/576 (1.9%) | 12 | 13/574 (2.3%) | 13 |
| Pacemaker generated arrhythmia | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Peripheral swelling | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Pyrexia | 3/576 (0.5%) | 3 | 0/574 (0%) | 0 |
| Submandibular mass | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Sudden cardiac death | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Systemic inflammatory response syndrome | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Vascular stent thrombosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Hepatobiliary disorders | ||||
| Bile duct obstruction | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Bile duct stone | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Cholecystitis | 2/576 (0.3%) | 2 | 3/574 (0.5%) | 3 |
| Cholecystitis acute | 5/576 (0.9%) | 6 | 3/574 (0.5%) | 3 |
| Cholelithiasis | 2/576 (0.3%) | 2 | 3/574 (0.5%) | 3 |
| Drug-induced liver injury | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Gallbladder disorder | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Gallbladder perforation | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Immune system disorders | ||||
| Drug hypersensitivity | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Infections and infestations | ||||
| Abdominal wall abscess | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Abscess limb | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Abscess neck | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Acute sinusitis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Anal abscess | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Appendicitis | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Arthritis bacterial | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Bacteraemia | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Bronchitis | 4/576 (0.7%) | 4 | 2/574 (0.3%) | 2 |
| Cellulitis | 12/576 (2.1%) | 15 | 11/574 (1.9%) | 13 |
| Cellulitis staphylococcal | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Clostridium difficile colitis | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Clostridium difficile infection | 0/576 (0%) | 0 | 3/574 (0.5%) | 3 |
| Colonic abscess | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Device related infection | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Diabetic foot infection | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Diverticulitis | 2/576 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Endocarditis | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Enteritis infectious | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Enterobacter sepsis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Enterococcal bacteraemia | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Epididymitis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Epiglottitis | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Gangrene | 2/576 (0.3%) | 6 | 1/574 (0.2%) | 1 |
| Gastroenteritis | 4/576 (0.7%) | 4 | 4/574 (0.7%) | 4 |
| Haematoma infection | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Haemophilus infection | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Implant site infection | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Incision site cellulitis | 2/576 (0.3%) | 2 | 4/574 (0.7%) | 4 |
| Incision site infection | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Infected skin ulcer | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Influenza | 3/576 (0.5%) | 3 | 2/574 (0.3%) | 2 |
| Localised infection | 7/576 (1.2%) | 7 | 15/574 (2.6%) | 15 |
| Mediastinitis | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Medical device site infection | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Meningitis | 0/576 (0%) | 0 | 1/574 (0.2%) | 2 |
| Osteomyelitis | 5/576 (0.9%) | 5 | 4/574 (0.7%) | 8 |
| Perirectal abscess | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Pneumonia | 39/576 (6.8%) | 51 | 36/574 (6.3%) | 40 |
| Post procedural pneumonia | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Postoperative wound infection | 19/576 (3.3%) | 27 | 18/574 (3.1%) | 20 |
| Sepsis | 4/576 (0.7%) | 4 | 2/574 (0.3%) | 2 |
| Septic shock | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Streptococcal infection | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Subcutaneous abscess | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Subdural empyema | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Tracheobronchitis | 3/576 (0.5%) | 3 | 0/574 (0%) | 0 |
| Upper respiratory tract infection | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Urinary tract infection | 5/576 (0.9%) | 5 | 10/574 (1.7%) | 10 |
| Urosepsis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Viral infection | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Wound abscess | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Wound infection | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Agitation postoperative | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Alcohol poisoning | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Anaemia postoperative | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Ankle fracture | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Arteriovenous fistula site complication | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Arteriovenous fistula site haematoma | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Brachial plexus injury | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Cervical vertebral fracture | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Coronary vascular graft occlusion | 5/576 (0.9%) | 6 | 3/574 (0.5%) | 3 |
| Deep vein thrombosis postoperative | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Endotracheal intubation complication | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Extradural haematoma | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Facial bones fracture | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Fall | 3/576 (0.5%) | 3 | 1/574 (0.2%) | 1 |
| Femoral neck fracture | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Fracture | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Gastrointestinal injury | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Graft haemorrhage | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Haemodialysis-induced symptom | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Head injury | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Hip fracture | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Humerus fracture | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Incision site complication | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Incision site haematoma | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Incision site haemorrhage | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Incision site pain | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Joint dislocation | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Lower limb fracture | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Mental status changes postoperative | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Multiple fractures | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Muscle strain | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Overdose | 0/576 (0%) | 0 | 1/574 (0.2%) | 2 |
| Pelvic fracture | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Perirenal haematoma | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Peritoneal dialysis complication | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Post procedural haematoma | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Post procedural haematuria | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Post procedural haemorrhage | 6/576 (1%) | 6 | 4/574 (0.7%) | 4 |
| Post procedural myocardial infarction | 1/576 (0.2%) | 1 | 4/574 (0.7%) | 4 |
| Post procedural swelling | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Postoperative ileus | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Postoperative respiratory distress | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Postoperative respiratory failure | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Postoperative thoracic procedure complication | 3/576 (0.5%) | 3 | 1/574 (0.2%) | 1 |
| Postoperative wound complication | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Procedural complication | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Procedural hypotension | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Procedural pain | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Procedural pneumothorax | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Procedural site reaction | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Radiation dysphagia | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Radiation proctitis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Rib fracture | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Road traffic accident | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Scrotal haematoma | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Seroma | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Spinal cord injury | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Subarachnoid haemorrhage | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Subdural haematoma | 1/576 (0.2%) | 2 | 2/574 (0.3%) | 2 |
| Toxicity to various agents | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Traumatic fracture | 0/576 (0%) | 0 | 1/574 (0.2%) | 2 |
| Vascular graft occlusion | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Vascular graft stenosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Vascular pseudoaneurysm | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Vasoplegia syndrome | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Wound | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Wound dehiscence | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Investigations | ||||
| Anticoagulation drug level above therapeutic | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Arthroscopy | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Blood potassium decreased | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Electrocardiogram QT prolonged | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Electroencephalogram | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Influenza B virus test positive | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| International normalised ratio increased | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Medical observation | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Oxygen consumption increased | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Oxygen saturation decreased | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Transaminases increased | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 2/576 (0.3%) | 2 | 9/574 (1.6%) | 9 |
| Diabetes mellitus inadequate control | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Diabetic ketoacidosis | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 3 |
| Failure to thrive | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Fluid overload | 2/576 (0.3%) | 4 | 5/574 (0.9%) | 6 |
| Fluid retention | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Gout | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Hyperglycaemia | 3/576 (0.5%) | 3 | 1/574 (0.2%) | 1 |
| Hyperglycaemic hyperosmolar nonketotic syndrome | 0/576 (0%) | 0 | 1/574 (0.2%) | 3 |
| Hyperkalaemia | 3/576 (0.5%) | 3 | 0/574 (0%) | 0 |
| Hypoglycaemia | 0/576 (0%) | 0 | 6/574 (1%) | 6 |
| Hypokalaemia | 2/576 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Hyponatraemia | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Hypovolaemia | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthritis | 2/576 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Cervical spinal stenosis | 3/576 (0.5%) | 3 | 0/574 (0%) | 0 |
| Costochondritis | 3/576 (0.5%) | 3 | 1/574 (0.2%) | 1 |
| Intervertebral disc protrusion | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Lumbar spinal stenosis | 3/576 (0.5%) | 3 | 1/574 (0.2%) | 1 |
| Muscle haemorrhage | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Muscular weakness | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Musculoskeletal chest pain | 7/576 (1.2%) | 9 | 12/574 (2.1%) | 12 |
| Musculoskeletal pain | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Myopathy | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Myositis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Osteoarthritis | 9/576 (1.6%) | 10 | 10/574 (1.7%) | 10 |
| Pain in extremity | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Rhabdomyolysis | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Rotator cuff syndrome | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Spinal column stenosis | 2/576 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Spondylolisthesis | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Tenosynovitis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Vertebral foraminal stenosis | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute myeloid leukaemia | 1/576 (0.2%) | 3 | 0/574 (0%) | 0 |
| Adenocarcinoma gastric | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Adenocarcinoma of colon | 1/576 (0.2%) | 2 | 0/574 (0%) | 0 |
| B-cell lymphoma | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Carcinoid tumour pulmonary | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Chronic lymphocytic leukaemia | 0/576 (0%) | 0 | 1/574 (0.2%) | 2 |
| Clear cell renal cell carcinoma | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Colon adenoma | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Colon cancer | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Hepatocellular carcinoma | 1/576 (0.2%) | 3 | 1/574 (0.2%) | 4 |
| Lung adenocarcinoma | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Lung adenocarcinoma stage III | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Lung cancer metastatic | 0/576 (0%) | 0 | 3/574 (0.5%) | 3 |
| Lung neoplasm malignant | 1/576 (0.2%) | 1 | 3/574 (0.5%) | 3 |
| Malignant melanoma | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Malignant neoplasm progression | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Malignant pleural effusion | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Metastatic malignant melanoma | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Non-Hodgkin's lymphoma stage I | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Non-small cell lung cancer metastatic | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Oesophageal adenocarcinoma | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Oesophageal carcinoma | 1/576 (0.2%) | 2 | 2/574 (0.3%) | 3 |
| Oropharyngeal cancer | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Pituitary tumour benign | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Prostate cancer | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Renal cell carcinoma | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Small cell lung cancer | 0/576 (0%) | 0 | 2/574 (0.3%) | 3 |
| Small cell lung cancer metastatic | 0/576 (0%) | 0 | 2/574 (0.3%) | 3 |
| Squamous cell carcinoma | 1/576 (0.2%) | 2 | 0/574 (0%) | 0 |
| Squamous cell carcinoma of lung | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Thyroid cancer | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Transitional cell carcinoma | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Tumour necrosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Nervous system disorders | ||||
| Amyotrophic lateral sclerosis | 1/576 (0.2%) | 2 | 0/574 (0%) | 0 |
| Autonomic nervous system imbalance | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Basal ganglia haemorrhage | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Brain hypoxia | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Carotid artery stenosis | 6/576 (1%) | 7 | 4/574 (0.7%) | 5 |
| Carotid artery thrombosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Cerebellar infarction | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Cerebral haemorrhage | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Cerebral infarction | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Cerebrovascular accident | 17/576 (3%) | 22 | 20/574 (3.5%) | 23 |
| Cervical myelopathy | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Clonus | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Cognitive disorder | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Dementia | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Dementia Alzheimer's type | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Dizziness | 4/576 (0.7%) | 4 | 0/574 (0%) | 0 |
| Dizziness postural | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Dyskinesia | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Embolic stroke | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Encephalopathy | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Epilepsy | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Generalised tonic-clonic seizure | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Haemorrhagic cerebral infarction | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Haemorrhagic stroke | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Hemiparesis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Horner's syndrome | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Hypoaesthesia | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Intensive care unit acquired weakness | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Loss of consciousness | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Lumbar radiculopathy | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Migraine | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Monoparesis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Neuralgia | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Neuroleptic malignant syndrome | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Neuropathy peripheral | 3/576 (0.5%) | 3 | 0/574 (0%) | 0 |
| Paraesthesia | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Poor quality sleep | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Presyncope | 3/576 (0.5%) | 3 | 1/574 (0.2%) | 1 |
| Seizure | 2/576 (0.3%) | 3 | 4/574 (0.7%) | 4 |
| Somnolence | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Syncope | 7/576 (1.2%) | 8 | 3/574 (0.5%) | 3 |
| Transient ischaemic attack | 6/576 (1%) | 6 | 3/574 (0.5%) | 3 |
| Vertebral artery thrombosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Product Issues | ||||
| Device dislocation | 1/576 (0.2%) | 2 | 1/574 (0.2%) | 1 |
| Device failure | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Device kink | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Device malfunction | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Psychiatric disorders | ||||
| Aggression | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Alcohol withdrawal syndrome | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Anxiety | 3/576 (0.5%) | 4 | 2/574 (0.3%) | 3 |
| Bipolar disorder | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Conversion disorder | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Delirium | 2/576 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Delirium tremens | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Depression | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Drug use disorder | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Homicidal ideation | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Major depression | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Mental status changes | 2/576 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Panic attack | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Stress | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Substance use disorder | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Suicidal ideation | 5/576 (0.9%) | 6 | 5/574 (0.9%) | 11 |
| Suicide attempt | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Violence-related symptom | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 16/576 (2.8%) | 19 | 13/574 (2.3%) | 17 |
| Chronic kidney disease | 3/576 (0.5%) | 3 | 1/574 (0.2%) | 1 |
| Diabetic nephropathy | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| End stage renal disease | 1/576 (0.2%) | 1 | 6/574 (1%) | 7 |
| Haematuria | 0/576 (0%) | 0 | 1/574 (0.2%) | 2 |
| Nephrolithiasis | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Nephrotic syndrome | 0/576 (0%) | 0 | 1/574 (0.2%) | 2 |
| Polyuria | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Renal artery stenosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Renal failure | 0/576 (0%) | 0 | 3/574 (0.5%) | 3 |
| Renal mass | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Renal tubular necrosis | 2/576 (0.3%) | 2 | 0/574 (0%) | 0 |
| Ureterolithiasis | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Urinary tract obstruction | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 2/576 (0.3%) | 2 | 5/574 (0.9%) | 5 |
| Erectile dysfunction | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute pulmonary oedema | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Acute respiratory distress syndrome | 2/576 (0.3%) | 2 | 3/574 (0.5%) | 3 |
| Acute respiratory failure | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Aspiration | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Asthma | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Atelectasis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Bronchial secretion retention | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Choking | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Chronic obstructive pulmonary disease | 10/576 (1.7%) | 17 | 13/574 (2.3%) | 18 |
| Cough | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Diaphragmatic paralysis | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Dyspnoea | 1/576 (0.2%) | 1 | 3/574 (0.5%) | 3 |
| Dyspnoea exertional | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Epistaxis | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Haemoptysis | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Hypoxia | 3/576 (0.5%) | 3 | 4/574 (0.7%) | 4 |
| Mediastinal haemorrhage | 1/576 (0.2%) | 1 | 3/574 (0.5%) | 3 |
| Pleural effusion | 25/576 (4.3%) | 27 | 17/574 (3%) | 23 |
| Pneumonia aspiration | 3/576 (0.5%) | 3 | 3/574 (0.5%) | 4 |
| Pneumothorax | 3/576 (0.5%) | 3 | 2/574 (0.3%) | 2 |
| Pulmonary congestion | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Pulmonary embolism | 9/576 (1.6%) | 10 | 9/574 (1.6%) | 9 |
| Pulmonary fibrosis | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Pulmonary mass | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Pulmonary oedema | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Respiratory distress | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Respiratory failure | 5/576 (0.9%) | 5 | 11/574 (1.9%) | 11 |
| Thoracic haemorrhage | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Angioedema | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Cold sweat | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Dermatitis contact | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Diabetic foot | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Skin ulcer | 2/576 (0.3%) | 3 | 3/574 (0.5%) | 3 |
| Social circumstances | ||||
| Homeless | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Surgical and medical procedures | ||||
| Abdominal panniculectomy | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Ankle arthroplasty | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Arteriovenous fistula operation | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Arteriovenous graft | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Bladder neoplasm surgery | 0/576 (0%) | 0 | 3/574 (0.5%) | 4 |
| Cardiac pacemaker replacement | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Cardioversion | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Chemotherapy | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Cholecystectomy | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 1 |
| Coronary revascularisation | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Debridement | 2/576 (0.3%) | 2 | 2/574 (0.3%) | 2 |
| Dialysis device insertion | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Drug rehabilitation | 0/576 (0%) | 0 | 1/574 (0.2%) | 2 |
| Elective procedure | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Gastrointestinal tube insertion | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Hip arthroplasty | 0/576 (0%) | 0 | 5/574 (0.9%) | 5 |
| Incisional drainage | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Intervertebral disc operation | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Knee arthroplasty | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Medical device removal | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Metabolic surgery | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Multiple drug therapy | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Nephrectomy | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Pancreatic stent placement | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Parotidectomy | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Peripheral artery bypass | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Renal transplant | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Shoulder arthroplasty | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Spinal fusion surgery | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Spinal laminectomy | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Spinal operation | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Sternal wiring | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Suture removal | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Wound drainage | 0/576 (0%) | 0 | 3/574 (0.5%) | 3 |
| Vascular disorders | ||||
| Aneurysm | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Aortic aneurysm | 2/576 (0.3%) | 2 | 6/574 (1%) | 6 |
| Aortic dissection | 0/576 (0%) | 0 | 3/574 (0.5%) | 3 |
| Arteriosclerosis | 0/576 (0%) | 0 | 2/574 (0.3%) | 2 |
| Deep vein thrombosis | 5/576 (0.9%) | 6 | 8/574 (1.4%) | 8 |
| Distributive shock | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Essential hypertension | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Haematoma | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Haemodynamic instability | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Hypertension | 1/576 (0.2%) | 1 | 4/574 (0.7%) | 4 |
| Hypertensive crisis | 1/576 (0.2%) | 1 | 2/574 (0.3%) | 2 |
| Hypertensive emergency | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 2 |
| Hypotension | 7/576 (1.2%) | 7 | 7/574 (1.2%) | 7 |
| Iliac artery occlusion | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Ischaemia | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Jugular vein thrombosis | 2/576 (0.3%) | 2 | 1/574 (0.2%) | 1 |
| Microembolism | 1/576 (0.2%) | 1 | 0/574 (0%) | 0 |
| Orthostatic hypotension | 4/576 (0.7%) | 4 | 5/574 (0.9%) | 6 |
| Peripheral arterial occlusive disease | 3/576 (0.5%) | 3 | 4/574 (0.7%) | 4 |
| Peripheral artery aneurysm | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 2 |
| Peripheral embolism | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Peripheral ischaemia | 2/576 (0.3%) | 3 | 3/574 (0.5%) | 3 |
| Peripheral vascular disorder | 2/576 (0.3%) | 3 | 1/574 (0.2%) | 1 |
| Peripheral venous disease | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Steal syndrome | 1/576 (0.2%) | 1 | 1/574 (0.2%) | 2 |
| Subclavian vein thrombosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Thrombophlebitis superficial | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Thrombosis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
| Vasculitis | 0/576 (0%) | 0 | 1/574 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
| Name/Title | Marco Zenati, M.D. |
|---|---|
| Organization | VA Boston Healthcare System |
| Phone | 857-203-6815 |
| Marco.Zenati@va.gov |
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01850082
Other Study ID Numbers:
- 588
First Posted:
May 9, 2013
Last Update Posted:
Dec 15, 2021
Last Verified:
Nov 1, 2021