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

Sponsor

Karolinska University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05346289

Collaborator

Medical University of Graz, Austria (Other), St. Olav University Hospital, Trondheim, Norway (Other)

400

Enrollment

Location

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm Without Rupture Aneurysm Aortic Aneurysm Aneurysm Abdominal	Procedure: Elective surgery for intact AAA

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 Design

Study Type:

Observational

Actual Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

Feb 14, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Women	Procedure: Elective surgery for intact AAA Elective surgery including the following modalities: open repair, endovascular repair (EVAR), fenestrated end-vascular repair (FEVAR).
Men	Procedure: Elective surgery for intact AAA Elective surgery including the following modalities: open repair, endovascular repair (EVAR), fenestrated end-vascular repair (FEVAR).

Arm

Intervention/Treatment

Women

Procedure: Elective surgery for intact AAA

Elective surgery including the following modalities: open repair, endovascular repair (EVAR), fenestrated end-vascular repair (FEVAR).

Men

Procedure: Elective surgery for intact AAA

Elective surgery including the following modalities: open repair, endovascular repair (EVAR), fenestrated end-vascular repair (FEVAR).

Outcome Measures

Primary Outcome Measures

Final Elective Treatment Status [End of follow-up in December 2021 with maximal possible follow-up of seven years.]
Relative frequency of women and men that were electively treated or left untreated, the latter group subcategorized into patients who did or did not reach the diameter threshold for surgical treatment (50 mm women, 55 men).
Sex-Specific Reasons for Remaining Untreated [Evaluated at the time of the conservative treatment decision during maximal follow-up of seven years.]
Frequency distribution of underlying reasons behind non-treatment among those men and women who reached the treatment threshold. Primary reason registered as patient- (comorbidity, patient's wish) or AAA-related (morphology).

Secondary Outcome Measures

Rupture Rate [Study end December 2021.]
Sex-specific rates of rupture in each treatment arm during follow-up.
Mortality Rate [Study end December 2021.]
Sex-specific rates of mortality in each treatment arm during follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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