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Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) (OVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00094575
Recruitment Status : Completed
First Posted : October 21, 2004
Results First Posted : December 31, 2013
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Procedure: Endovascular Repair Procedure: Standard Open Repair Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 881 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CSP #498 - Open Versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms
Study Start Date : October 2002
Actual Primary Completion Date : October 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1
Standard Open Repair of Abdominal Aortic Aneurysm
 Procedure: Standard Open Repair
Standard Open Repair
Active Comparator: Arm 2
Endovascular Repair of Abdominal Aortic Aneurysm
 Procedure: Endovascular Repair
Endovascular Repair


Outcome Measures
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Primary Outcome Measures :
  1. All-cause Mortality [ Time Frame: 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 :
  1. Secondary Therapeutic Procedures [ Time Frame: 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.

  2. SF-36 Mental Component Score (MCS) [ Time Frame: 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.


  3. SF-36 Physical Component Score (PCS) [ Time Frame: 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.


  4. SF-36 Physical Component Deaths Included Score (PCTD) [ Time Frame: 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.


  5. European Quality of Life-5 Dimension (EQ-5D) Index Score [ Time Frame: 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.


  6. European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale [ Time Frame: 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.


  7. International Index of Erectile Function (IIEF-5) [ Time Frame: 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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094575


Locations
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Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Study Chair: Frank A. Lederle, MD Minneapolis Veterans Affairs Medical Center
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00094575    
Other Study ID Numbers: 498
First Posted: October 21, 2004    Key Record Dates
Results First Posted: December 31, 2013
Last Update Posted: March 7, 2016
Last Verified: February 2016
Keywords provided by VA Office of Research and Development:
Abdominal
Aortic Aneurysm
cost of AAA repair
Endovascular Repair
 Grafts
Long-term survival
secondary outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases