Elective Treatment Rates and Surgical Non-eligibility Among Men and Women With Intact Abdominal Aortic Aneurysms

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Elective Treatment Rates and Surgical Non-eligibility Among Men and Women With Intact Abdominal Aortic Aneurysms

Official Title

Elective Treatment Rates Among Patients With Intact Abdominal Aortic Aneurysms -Patient- and Aneurysm-related Factors as Determinants of Surgical Non-eligibility in Women and Men

Brief Summary

      The overall aim is to determine the frequency by which women and men with intact abdominal
      aortic aneurysms (AAA) are treated with elective surgery at three vascular outpatient clinics
      in Europe, and to investigate whether the reasons to refrain from elective surgery differ
      between the sexes.

Detailed Description

      Abdominal aortic aneurysm (AAA) is a local widening of the infrarenal aorta (1). The natural
      history of AAA is progressive and may lead to rupture, a true surgical emergency with a
      mortality rate of 100% without immediate treatment. Men are more commonly affected (2, 3),
      however, women demonstrate a notably elevated risk of rupture (4, 5) and constitute up to 1/3
      of all ruptures (4, 5). One plausible explanation could be a sex discrepancy in elective
      treatment rates.

      There is both national and international evidence implying that AAA treatments, both elective
      and emergent, are withheld among women (6-14). Studies on elective treatment rates are
      especially scarce, as the vast majority of databases and vascular registries only include
      data on treated AAA patients. A few single-center studies from the UK (6, 7, 15) and one
      meta-analysis (8) have recorded lower treatment rates among women. We have recently analyzed
      the issue of elective treatment rates in our group using a population-based approach
      (manuscript submitted). Of all patients diagnosed with an intact AAA in Sweden during
      2001-2015 (n=32 393, 21% women), a crude proportion as high as 60 % did not proceed to
      receive surgical treatment. The proportion of untreated women (67 %) surpassed that of men
      (59 %). In the multivariate analyses, female sex and advanced age emerged as the strongest
      predictors for remaining untreated despite other characteristics such as comorbidities, civil
      status and individual disposable household income. The median time from diagnosis to
      treatment for those treated was surprisingly short at 1.6 years.

      The foremost intention-to-treat variable that determines the indication for elective surgery
      is the maximal diameter of the aneurysm (55 mm in men, 50 mm in women; (16, 17)).
      Population-based investigations, while comprehensive, fall short in terms of
      aneurysm-specific data. Therefore, these analyses assume comparable diameter distributions
      and similar morphology for men and women. Similarly, longitudinal follow-up data from the
      clinical setting, such as records of patient's wishes and physiological preoperative
      examinations, cannot be extracted for the purpose of nationwide analyses. Thus, the question
      remains whether the observed gender gap in elective treatment rates persists after detailed
      considerations of patient- and aneurysm-specific characteristics. A discrepancy in elective
      treatment rates could also lead to different long-term outcomes, with higher rupture and
      mortality rates among women.

Study Type

Observational

Primary Outcome

Final Elective Treatment Status

Secondary Outcome

 Rupture Rate

Condition

Abdominal Aortic Aneurysm

Intervention

Elective surgery for intact AAA

Study Arms / Comparison Groups

 Women
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

400

Start Date

June 1, 2020

Completion Date

November 1, 2022

Primary Completion Date

February 14, 2022

Eligibility Criteria

        Inclusion Criteria:

        • Intact abdominal aortic aneurysm 30 mm or larger in men and women irrespective of
        underlying pathogenesis (atherosclerotic, mycotic, previous dissection).

        Exclusion Criteria:

          -  Previous aortic surgery or surgical treatment for AAA

          -  Ruptured AAA at index contact

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations

NCT ID

NCT05346289

Organization ID

ESPN201689310422

Responsible Party

Principal Investigator

Study Sponsor

Karolinska University Hospital

Collaborators

 Medical University of Graz

Study Sponsor

, ,

Verification Date

November 2022