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Sex Differences in Outcomes After Transcatheter Aortic Valve Replacement: A POPular TAVI Subanalysis

https://doi.org/10.1016/j.jcin.2023.02.039Get rights and content

Abstract

Background

Stroke and bleeding are complications after transcatheter aortic valve replacement (TAVR). A higher incidence of bleeding and stroke has been reported in women, but the role of antithrombotic management pre- and post-TAVR has not been studied.

Objectives

The study sought to compare bleeding and ischemic complications after TAVR between women and men stratified by antiplatelet and oral anticoagulant (OAC) regimen.

Methods

The POPular TAVI (Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation) trial was a randomized clinical trial to test the hypothesis that monotherapy with aspirin or OAC after TAVR is safer than the addition of clopidogrel. The primary endpoints of interest of this post hoc subanalysis were: 1) all bleeding; and 2) a composite of ischemic events consisting of stroke and myocardial infarction. Secondary endpoints were: 1) nonprocedural bleeding; 2) major or life-threatening bleeding; 3) minor bleeding; 4) stroke; 5) myocardial infarction; and 6) all-cause death.

Results

A total of 978 patients (466 [47.6%] women) were included in this study. All bleeding and the composite of myocardial infarction and stroke rates were similar between sexes (all bleeding: 106 [22.8%] women vs 121 [23.6%] men; P = 0.815; ischemic events: 26 [5.6%] vs 36 [7.0%]; P = 0.429). However, major or life-threatening bleeding occurred more often in women (58 [12.5%]) vs men (38 [7.4%]) (P = 0.011), most of which were access site bleedings. The use of aspirin pre- and post-TAVR increased major or life-threatening bleeding in women but not in men.

Conclusions

After TAVR, overall bleeding and ischemic outcomes were similar between women and men. However, women had more major or life-threatening bleedings, especially those receiving aspirin pre- and post-TAVR.

Section snippets

Study design

The POPular TAVI Trial was an investigator-initiated, parallel-group, randomized open-label trial to test the hypothesis that monotherapy with aspirin or OAC after TAVR is safer than the addition of clopidogrel.13 The study consisted of 2 cohorts, based on indication for OAC prior to TAVR. Patients without an indication for OAC were randomized between aspirin with or without clopidogrel for 3 months after TAVR in a 1:1 ratio (cohort A). In cohort A, for patients on maintenance antiplatelet

Results

Baseline characteristics are shown in Table 1. Women were older (81.24 ± 5.46 years vs 79.39 ± 6.70 years; P < 0.001), had higher body mass index (27.49 ± 5.69 kg/m2 vs 26.89 ± 3.90 kg/m2; P = 0.055), a higher Society of Thoracic Surgeons Predicted Risk of Mortality score (3.60 ± 2.62 vs 3.03 ± 2.29; P < 0.001), less diabetes mellitus (no diabetes mellitus 78.1% in women vs 70.7% in men), less chronic obstructive pulmonary disease (16.3% vs 22.1%; P = 0.023), less coronary artery disease (27.5%

Discussion

In this explorative post hoc analysis of the POPular TAVI Trial, we showed that: 1) the incidence of all bleeding and ischemic outcomes was similar between women and men after TAVR, but of these bleedings, the risk of major or life-threatening bleeding was higher in women; 2) the overall distribution of bleeding sites showed a higher risk of pericardial bleeding in women, with access site bleedings being the most frequent, and among these patients this tended to be more severe in women; 3)

Conclusions

In this post hoc subanalysis, risks of bleeding and ischemic outcomes after TAVR were similar between men and women. However, there was a higher risk of major or life-threatening bleeding in women. This risk was higher in women as compared with men on aspirin pre- and post-TAVR. These outcomes may suggest that a different approach of antithrombotic therapy for men or women pre- and post-TAVR is useful. Further (prospective) research on sex differences on antithrombotic therapy after TAVR is

Funding Support and Author Disclosures

The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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    • Cited by (5)

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    ∗

    Drs van Bergeijk and van Ginkel contributed equally to this work.

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    © 2023 by the American College of Cardiology Foundation. Published by Elsevier.