Sex Differences in Clinical Characteristics and Outcomes of Patients Undergoing Catheter–directed Treatments for High Risk and Intermediate–high Risk Acute Pulmonary Embolism. Do We Need Sex–specific Considerations in the Management of Acute Pe?

Abstract Background Acute pulmonary embolism (PE) is a common disease associated with a high mortality rate. Catheter–Directed Treatments (CDTs) could address some unsolved issues in high and intermediate–high risk PE patients evolving towards hemodynamic deterioration when systemic thrombolysis (ST) is contraindicated or fails. Few data in literature suggest that female patients hospitalized for PE experience adverse clinical outcomes as compared with their male counterparts. However, whether there is a specific impact of sex on CDTs outcomes in PE within real–world clinical settings remains unexplored. Methods This is a multicenter retrospective study including patients admitted in five Italian Centers, who underwent CDTs for high and intermediate–high risk PE, as defined by ESC Guidelines. In–hospital and one–year clinical outcomes were evaluated using medical records and follow–up assessments. Bleeding events were defined according to the Bleeding Academic Research Consortium (BARC) criteria. Results A total of 191 patients were included, 101 women (52.9%) and 90 men (47.1%). High risk PE was diagnosed in 56 (29%) patients, while intermediate–high risk PE was diagnosed in 135 (71%). Of these, 132 (69%) were treated by ultrasound–assisted thrombolysis (USAT), with negligible sex disparity between treatment modalities. Notably, female patients presented more frequently with cardiac arrest (11% vs. 2.6%, p = 0.03), had lower prevalence of absolute contraindications to ST (23% vs. 42%, p = 0.004) and history of recent major surgery (8.9% vs. 22%, p = 0.01). Female patients had a trend towards higher procedural–related complications (17% versus 9%, OR 2.07 95%CI 0.87–5.33, p=0.11), higher in–hospital mortality rate (20% versus 8.9%, OR 2.53 95%C.I. 1.09–6.41, p=0.038) and higher likelihood of bleeding events (22% versus 10%, OR 2.54 95%CI 1.13–6.14, p=0.029). At 1 year follow–up, female sex was associated with higher all–cause mortality (29.1% versus 12.7%, HR 2.50 95%CI 1.15–5.43, p=0.022). Multivariate regression analysis identified female sex, diagnosis of high–risk PE and a history of neoplasia as independent predictors of 1–year all–cause mortality. Conclusions In our experience, female patients undergoing CDTs for acute PE showed worse clinical presentation, higher procedural–related complications, and poorer outcomes than males. In our opinion this sex disparity underscores the need for sex–specific considerations in acute PE management strategies.