Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA)
- Conditions
- Aortic Aneurysm
- Interventions
- Procedure: Standard Open RepairProcedure: Endovascular Repair
- Registration Number
- NCT00094575
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
A multi-center, randomized clinical trial that will compare endovascular repair with standard open surgery in the repair of abdominal aortic aneurysms (AAA). Long and short-term results as well as the cost and quality of life associated with these two strategies for AAA repair will be compared.
- Detailed Description
Primary Hypothesis: All-cause mortality will differ by 25% between Endovascular repair (EVR) and Open repair. Secondary Hypotheses: Procedure failure, short term (12-month) major morbidity, number of hospital days, health-related quality of life and other procedure-related abnormalities will differ between the two AAA repair strategies. Primary Outcomes: All-cause mortality. Interventions: Patients will be randomized to one of these repair strategies for the elective treatment of AAA: (a) Open repair or (b) Endovascular repair (using FDA-approved devices). Study Abstract: Aortic aneurysm is the tenth leading cause of death in older men; AAA accounts for the majority of these deaths (about 10,000 deaths per year in the United States). Since one in 22 Veterans over the age of 50 have AAA and one in 200 have AAA with diameter greater or equal to 5.0 cm (making them candidates for elective repair), AAA is a major disease in the VA population. Questions about the relative safety and effectiveness of FDA approved EVR devices have been raised and remain unanswered. To answer these questions, this multi-center, randomized clinical trial comparing EVR with standard open surgery is proposed. Patients for whom elective repair of AAA is indicated and who are suitable candidates for both open repair and EVR will be eligible for the study. The anticipated duration of the study is 9 years with a proposed sample size of 900 patients. The first planning meeting took place on March 9-10, 2000 and the second planning meeting took place on November 6-7, 2000. The OVER protocol was submitted and reviewed by CSEC on May 10, 2001 and approved. The kickoff was June 12, 2002. The first DSMB meeting took place January 6, 2003. First annual meeting was held September 30, 2003; second DSMB meeting took place September 29, 2003. Third DSMB meeting held on April 19, 2004; second annual meeting was held on June 29, 2004. Fourth DSMB meeting was held on December 6, 2004; third annual meeting was held on March 15, 2005. The fifth DSMB meeting was held on July 19, 2005 and the fourth annual meeting was held March 21, 2006. The sixth DSMB meeting was held September 12, 2005. The seventh DSMB meeting was held on March 6, 2006. The eighth DSMB meeting was held on November 6, 2006. At its November 6, 2006 meeting, the DSMB discussed and approved unblinding of the study chair to prepare the short-term follow-up paper as specified in the study protocol. Initially the protocol called for this analysis to include one-year follow-up data. After discussions with the Trial Leadership, the DSMB approved use of two year follow-up data (reflected in DSMB minutes finalized February 20, 2007). This recommendation was subsequently approved by CSP in March 2007. The short-term outcomes manuscript was published in JAMA on October 14, 2009. The ninth DSMB meeting was held on May 14, 2007 and the fifth annual meeting was held on June 6, 2007. The tenth DSMB meeting was held on April 7, 2008. The eleventh DMC (name change only from DSMB to DMC) was held on June 22, 2009. The twelfth DMC meeting was held on May 24, 2010. A Site Investigator meeting was held in Boston, MA on June 9, 2010. The thirteenth DMC meeting was held on June 3, 2011 and a study close-out meeting was held on June 15, 2011 in Chicago, IL. The study's patient follow-up phase ended October 15, 2011.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 881
-
AAA with a maximum external diameter in any plane greater than or equal to 5 cm.
-
An iliac aneurysm (associated with an AAA) with a maximum external diameter in any plane greater than or equal to 3 cm.
-
AAA greater than or equal to 4.5 cm and the AAA has increased by greater than or equal to 0.7 cm in diameter in 6 months.
-
An AAA greater than or equal to 4.5 cm and the AAA has increased by greater than or equal to 1 cm in diameter in 12 months.
-
An AAA greater than or equal to 4.5 cm and the AAA is saccular (i.e., a portion of the circumference of the aorta at the level of the aneurysm is considered normal based on CT scan or MRI).
-
An AAA greater than or equal to 4.5 cm and the AAA is associated with distal embolism.
- as measured from two imaging studies (ultrasound CT scan or MRI) within the appropriate interval, the later one within 6 months of randomization.
- Patient has had a previous AAA repair procedure
- Evidence of AAA rupture by imaging test
- AAA is not elective (i.e., urgent or emergent operation, usually due to suspected rupture)
- Likelihood of poor compliance to the protocol
- Patient refused randomization
- Physician refused randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Standard Open Repair Standard Open Repair of Abdominal Aortic Aneurysm Arm 2 Endovascular Repair Endovascular Repair of Abdominal Aortic Aneurysm
- Primary Outcome Measures
Name Time Method All-cause Mortality Participants were followed for the duration of the study, up to 9 years Participants vital status was assessed from randomization to end of study follow-up \[10/15/2011\] or death \[whichever occurred first\].
- Secondary Outcome Measures
Name Time Method SF-36 Mental Component Score (MCS) Outcome was assessed at 6 months and then yearly, up to 9 years Change (over time) since baseline in Mental Component Score of SF-36. The MCS Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.SF-36 Physical Component Deaths Included Score (PCTD) Outcome was assessed at 6 months and yearly thereafter, up to 9 years Change (over time) since baseline in Physical Component Deaths included Score of SF-36.
The PCTD Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.SF-36 Physical Component Score (PCS) Outcome was assessed at 6 months and yearly thereafter, up to 9 years Change (over time) since baseline in Physical Component Score of SF-36. The PCS Score ranges from 0-100 with higher scores indicating better health Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.Secondary Therapeutic Procedures Participants were followed for the duration of the study, up to 9 years This outcome includes any procedure that resulted directly or indirectly from the initial procedure and that required a separate trip to the procedure suite (with each trip to the procedure suite counting as one secondary procedure), including any unplanned surgical procedures within 30 days after the initial procedure and any additional aortoiliac procedures at any time.
European Quality of Life-5 Dimension (EQ-5D) Index Score Outcome was assessed at 6 months and yearly thereafter, up to 9 years Change (over time) since baseline in EQ-5D. The EQ-5D Index Score ('thermometer scale') ranges from 0 (worst health status) to 100 (best health status). Since this outcome captures change since baseline, values could be below 0.
Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale Outcome was assessed at 6 months and yearly thereafter, up to 9 years Change (over time) since baseline in EQ-5D Visual Analog Scale. The EQ-5D Visual Analog Scale ranges from 0 (death) to 1 (perfect health). Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.International Index of Erectile Function (IIEF-5) Outcome was assessed at 6 months and yearly thereafter, up to 9 years Change (over time) since baseline in IIEF-5. The IIEF-5 Score ranges from 5-25 with higher scores indicating better erectile function.
Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.
Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Trial Locations
- Locations (42)
VA New Jersey Health Care System, East Orange
🇺🇸East Orange, New Jersey, United States
Atlanta VA Medical and Rehab Center, Decatur
🇺🇸Decatur, Georgia, United States
VA Medical Center, Durham
🇺🇸Durham, North Carolina, United States
VA Medical Center, Cincinnati
🇺🇸Cincinnati, Ohio, United States
Michael E. DeBakey VA Medical Center (152)
🇺🇸Houston, Texas, United States
VA Pittsburgh Health Care System
🇺🇸Pittsburgh, Pennsylvania, United States
Southern Arizona VA Health Care System, Tucson
🇺🇸Tucson, Arizona, United States
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
🇺🇸No. Little Rock, Arkansas, United States
VA Medical Center, Long Beach
🇺🇸Long Beach, California, United States
VA San Diego Healthcare System, San Diego
🇺🇸San Diego, California, United States
VA Medical Center, Loma Linda
🇺🇸Loma Linda, California, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
VA Greater Los Angeles Healthcare System, West LA
🇺🇸West Los Angeles, California, United States
North Florida/South Georgia Veterans Health System
🇺🇸Gainesville, Florida, United States
VA Connecticut Health Care System (West Haven)
🇺🇸West Haven, Connecticut, United States
James A. Haley Veterans Hospital, Tampa
🇺🇸Tampa, Florida, United States
VA Medical Center, DC
🇺🇸Washington, District of Columbia, United States
Jesse Brown VAMC (WestSide Division)
🇺🇸Chicago, Illinois, United States
VA Medical Center, Iowa City
🇺🇸Iowa City, Iowa, United States
VA Medical Center, Lexington
🇺🇸Lexington, Kentucky, United States
VA Maryland Health Care System, Baltimore
🇺🇸Baltimore, Maryland, United States
VA Boston Healthcare System, Brockton Campus
🇺🇸Brockton, Massachusetts, United States
Minneapolis VA Health Care System
🇺🇸Minneapolis, Minnesota, United States
New Mexico VA Health Care System, Albuquerque
🇺🇸Albuquerque, New Mexico, United States
VA Western New York Healthcare System at Buffalo
🇺🇸Buffalo, New York, United States
New York Harbor HCS
🇺🇸New York, New York, United States
VA Medical Center, Cleveland
🇺🇸Cleveland, Ohio, United States
VA Medical Center, Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
VA Medical Center, Memphis
🇺🇸Memphis, Tennessee, United States
VA Puget Sound Health Care System, Seattle
🇺🇸Seattle, Washington, United States
VA North Texas Health Care System, Dallas
🇺🇸Dallas, Texas, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
🇺🇸Madison, Wisconsin, United States
Zablocki VA Medical Center, Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
VA Medical Center, Birmingham
🇺🇸Birmingham, Alabama, United States
VA Medical Center, San Francisco
🇺🇸San Francisco, California, United States
VA Eastern Colorado Health Care System, Denver
🇺🇸Denver, Colorado, United States
John D. Dingell VA Medical Center, Detroit
🇺🇸Detroit, Michigan, United States
VA Medical Center, Omaha
🇺🇸Omaha, Nebraska, United States
VA Salt Lake City Health Care System, Salt Lake City
🇺🇸Salt Lake City, Utah, United States
VA Medical Center, Portland
🇺🇸Portland, Oregon, United States
Richard Roudebush VA Medical Center, Indianapolis
🇺🇸Indianapolis, Indiana, United States
Edward Hines, Jr. VA Hospital
🇺🇸Hines, Illinois, United States