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Page 14 of 19 Masiero et al. Mini-invasive Surg 2022;6:4 https://dx.doi.org/10.20517/2574-1225.2021.104

[78]
infarction was non-inferior (13.4% and 17.3%, respectively; 95%CI for non-inferiority, -11.9 to 4.0) . The
results of the recent GALILEO do not support rivaroxaban plus aspirin after TAVI in patients without an
OAC indication, while evidence supporting (N)OAC over VKA after TAVI in AF patients is currently
[79]
lacking . The results of these recent trials have been translated in the consensus document from the ESC
Working Group on Thrombosis and the European Association of Percutaneous Cardiovascular
Interventions, in collaboration with the ESC Council on Valvular Heart Disease on “management of
antithrombotic therapy in patients undergoing transcatheter aortic valve implantation” .
[80]

However, no specific recommendations have been indicated for women undergoing TAVI procedures. In
both Cohort A and Cohort B from POPular TAVI, almost half of the enrolled patients were women, with
no differences among the compared groups. However, no sub-analysis has been carried out to investigate
differences in outcomes by sex. Differences between males and females in short- and long-term clinical
outcomes of TAVI might exist . However, evidence based on randomized studies is lacking, and several
[39]
small studies yielded non-conclusive results [48-50,81] . Data from observational studies suggest sex disparities in
antiplatelet and antithrombotic management after TAVI; specifically, women were more likely to be
prescribed clopidogrel and less likely to be prescribed warfarin due to lower rates of atrial fibrillation in
women. Even though disparities in clinical presentation and procedural management were observed, no
[51]
significant difference in clinical outcomes was noted . A large meta-analysis of registry data published in
2015 demonstrated women had higher rates than men of major bleeding, vascular complications, and stroke
following TAVI; however, female sex was independently associated with improved survival at median
[39]
follow-up of one year . A recent meta-analysis of 47,188 patients (49.4% women) including low-risk
patients investigated TAVI outcomes by sex. At 30 days, women had more bleeding (P < 0.001), vascular
complications (P < 0.001), and stroke/transient ischemic attack (P = 0.02), while no differences emerged in
all-cause (P = 0.19) or cardiovascular death (P = 0.91) as compared to men .
[49]

The role of sex in determining the pharmacokinetic and pharmacodynamic responses to antithrombotic
medications has already been established . Importantly, signals of an increased risk of bleeding in women
[82]
have been identified, and this aspect deserves clinical attention.

[83]
Moreover, female sex is an independent predictor of anemia in patients with severe aortic stenosis . The
WIN-TAVI registry showed that not only is anemia a common finding in elderly females, but it is also
strongly related to the long-term prognosis. Nevertheless, patients with severe anemia were more likely to
be discharged on oral anticoagulants than those with mild-to-moderate or no anemia, partially explained by
the higher prevalence of peripheral artery disease . Therefore, in the case of OAC therapy, particular
[84]
attention has to be paid to hemoglobin values, and an accurate revaluation of the thrombotic and bleeding
risks might be suggested during follow up. As bleeding and vascular complications are essential issues for
women undergoing TAVI, antithrombotic and anticoagulant therapy should be established, paying
particular attention to patients’ characteristics, presence of comorbidities, and polytherapy that may
predispose to bleeding and thrombosis. Additionally, a greater awareness of sex-related issues in
antithrombotic and anticoagulant therapy should be promoted among physicians, and further evidence
from large clinical trials looking at the safety and efficacy balance of different antithrombotic strategies in
women is warranted to better inform the therapeutic decision making in daily clinical practice.

CONCLUSIONS
Unsolved issues and future directions
Different pathophysiology, baseline and morphological characteristics, clinical presentation, and outcomes
have been observed in women with AS undergoing TAVI. However, differently from ischemic heart disease