Sex-Based Differences in Periprocedural Complications Following Lower Extremity Peripheral Vascular Intervention
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Updated: Sep 2, 2025

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Published on: August 8, 2025
S Elissa Altin1,2, Mauro Gitto3,4, Eric A Secemsky5
1Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT (S.E.A.).
Insights
Women undergoing peripheral vascular intervention (PVI) face higher risks of complications, including bleeding, amputation, and mortality. These increased risks for female patients persist after accounting for other factors, highlighting a need for further research.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Health Outcomes Research
Background:
- Sex-based outcome disparities are known in cardiovascular interventions, but less is understood for lower extremity peripheral vascular intervention (PVI).
- Symptomatic peripheral artery disease (PAD) affects numerous individuals, with PVI being a common treatment modality.
Purpose of the Study:
- To investigate if female sex is an independent predictor of periprocedural complications following lower extremity PVI.
- To compare outcomes between men and women undergoing PVI for PAD.
Main Methods:
- Analysis of a large cohort (119,620 patients) undergoing lower extremity PVI from the Vascular Quality Initiative registry (September 2016 - March 2020).
- Multivariate logistic regression models were employed to assess the independent association between female sex and post-PVI complications, adjusting for baseline characteristics.
Main Results:
- Women (39.6%) had significantly higher risks of access site complications, including hematoma (OR 1.45), pseudoaneurysm (OR 1.69), and access site occlusion (OR 1.89).
- Higher risks were observed for target lesion dissection (OR 1.36), above-knee amputation (OR 1.37), and in-hospital mortality (OR 1.21) in women compared to men.
- These elevated risks remained significant even after adjusting for patient and procedural variables.
Conclusions:
- Women undergoing lower extremity PVI for symptomatic PAD experience a higher risk of periprocedural complications than men.
- The increased risk of bleeding, amputation, and mortality in women persists independently of other factors.
- Further investigation is warranted to understand and mitigate these sex-based outcome differences in PVI.
Background:
Women with coronary artery disease are shown to have worse outcomes after percutaneous coronary intervention compared with men; however, less is known about sex-based outcomes following lower extremity peripheral vascular intervention (PVI) for symptomatic peripheral artery disease. The study aims to assess whether female sex is independently associated with periprocedural complications in patients undergoing PVI.
Methods:
Analysis includes patients undergoing lower extremity PVI from September 2016 to March 2020 from the Vascular Quality Initiative registry. Multivariate logistic regression was used to assess the independent association of female sex with post-PVI complications.
Results:
Of the 119 620 patients included, 47 316 (39.6%) were women. Analysis reflected that women were at higher risk of developing access site complications, including any hematoma (odds ratio [OR], 1.45 [1.35-1.57]), hematoma requiring transfusion (OR, 2.24 [1.82-2.76]; P<0.001), hematoma requiring surgery (OR, 1.49 [1.19-1.86]; P<0.001), pseudoaneurysm (OR, 1.69 [1.39-2.05]; P<0.001), and access site occlusion (OR, 1.89 [1.15-3.08]; P<0.001). Women also faced higher risks of target lesion dissection (OR, 1.36 [1.26-1.46]; P<0.001), above-knee amputation (OR, 1.37 [1.18-1.58]; P<0.001), and in-hospital mortality (OR, 1.21 [1.07-1.38]; P=0.003).
Conclusions:
In a contemporary cohort, women undergoing lower extremity PVI for symptomatic peripheral artery disease were at higher risk than men of developing periprocedural complications, including moderate or severe access site bleeding, above-knee amputation, and in-hospital mortality. This increased risk persisted despite adjustment for differences in baseline patient or procedural characteristics and warrants further investigation.
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