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January 18, 2026Open HeartOpen Access

Sex-based differences in outcomes after transcatheter aortic valve implantation: a systematic review and meta-analysis of randomised trials

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Key result

Female sex is linked to ~36% lower mortality but higher major bleeding in intermediate-risk TAVI.

  • OR: 0.64
  • OR: 1.35

Why the study?

Evidence regarding sex-related differences after TAVI remains inconclusive, making it clinically relevant to clarify the role of sex in procedural outcomes.

Does female sex affect outcomes in patients with severe symptomatic aortic stenosis undergoing TAVI?

Population

15 225 participants across 14 RCTs undergoing TAVI

Comparison

Women vs men

Design

Systematic review and meta-analysis of randomised clinical trials

Authors

GFGonçalo Nuno Ferraz-CostaMAMariana de Jesus AlmeidaJSJoana Delgado Silva

Discussion

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Overview

Signals lower mortality yet higher bleeding in intermediate-risk TAVI; extends prior inconclusive RCT meta-analyses with subgroup findings.

Key Points

  • To evaluate sex-related differences in outcomes after transcatheter aortic valve implantation (TAVI) in randomized clinical trials.
  • Conducted a systematic review adhering to PRISMA guidelines.
  • Searched PubMed, EMBASE, and Web of Science for relevant RCTs until July 1, 2024.
  • Included studies comparing TAVI outcomes between women and men with primary outcome being all-cause mortality.
  • Calculated pooled odds ratios (ORs) using random-effects models.
  • Included 14 RCTs with 15,225 participants.
  • No overall difference in all-cause mortality between sexes (OR: 0.83).
  • Significant protective effect for female sex in intermediate-risk patients (OR: 0.64).
  • Women had a higher risk of major bleeding (OR: 1.35).
  • No significant differences in cardiovascular mortality, stroke/TIA, or PPI.

Structured PICO

Does female sex affect outcomes in patients with severe symptomatic aortic stenosis undergoing TAVI?

P
Population
15,225 patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI), pooled from 14 RCTs.
I
Intervention
Female sex in patients undergoing TAVI
C
Comparator
Male sex in patients undergoing TAVI
O
Outcome
All-cause mortalityhard clinical

Female sex is associated with lower all-cause mortality among intermediate-risk patients undergoing TAVI, but carries a higher overall risk of major bleeding compared to men.

Cite This Study

Ferraz-Costa et al. (2026) studied this question. Female sex was associated with a lower all-cause mortality (OR: 0.64) among intermediate-risk patients undergoing TAVI, but a higher risk of major bleeding (OR: 1.35).

synapsesocial.com/papers/696c77afeb60fb80d1395f53https://doi.org/10.1136/openhrt-2025-003642
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Revisiting Sex Equality With Transcatheter Aortic Valve Replacement Outcomes2015 · 247 citations
  2. 2Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients2016 · 5,109 citations
  3. 3Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery2010 · 7,243 citations
  4. 4Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients2017 · 3,035 citations
  5. 5Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients2019 · 4,902 citations