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临床试验/NCT05346289
NCT05346289已完成不适用

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

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
1
主要终点
Final Elective Treatment Status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Previous aortic surgery or surgical treatment for AAA
  • Ruptured AAA at index contact

结局指标

主要结局

Final Elective Treatment Status

时间窗: 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

时间窗: 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).

次要结局

  • Mortality Rate(Study end December 2021.)
  • Rupture Rate(Study end December 2021.)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecka Hultgren

Prof., Senior Consultant

Karolinska University Hospital

研究点 (1)

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