Gender-based differences in outcomes after successful transcatheter aortic valve implantation
(TAVI) in patients without an indication for oral anticoagulation have not been well
studied. We aim to evaluate gender-based differences in clinical outcomes after TAVI.
In the present analysis of the GALILEO (Global study comparing a rivaroxaban-based
antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic
valve replacement to optimize clinical outcomes) trial, patients with symptomatic
severe aortic stenosis and who underwent successful TAVI were stratified by gender.
The primary outcome was major adverse cardiac and cerebrovascular events (MACCEs),
a composite of all-cause mortality or thromboembolic events (including any stroke,
myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein
thrombosis, or pulmonary embolism). Major bleeding was defined as a composite of major,
life-threatening, or disabling Valve Academic Research Consortium-2 bleeding. Of 1,644
patients, 813 were female, and 831 were male. At baseline, female patients were older
and at higher surgical risk (Society of Thoracic Surgeons risk score: 4.7 ± 3.6 versus
3.6 ± 3.0, p <0.0001) than male patients. After adjustment for differences in baseline
clinical and procedural parameters, female patients had lower rates of MACCE (hazard
ratio [HR] 0.69, 95% confidence interval [CI] 0.49 to 0.96), all-cause mortality (HR
0.54, 95% CI 0.34 to 0.87), and noncardiovascular mortality (HR 0.33, 95% CI 0.15
to 0.75) at a median of 17 months of follow-up. By landmark analyses, these differences
appeared to emerge with a longer follow-up time. No significant differences in major,
life-threatening, or disabling bleeding, cardiovascular mortality, and stroke were
noted. In conclusion, compared with male patients, female patients with severe symptomatic
aortic stenosis had a lower risk of MACCE and mortality but a similar risk of bleeding
events after TAVI.
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References
- 2017 ESC/EACTS Guidelines for the management of valvular heart disease.Eur Heart J. 2017; 38: 2739-2791
- Sex differences in transfemoral transcatheter aortic valve replacement.J Am Coll Cardiol. 2019; 74: 2758-2767
- Effect of gender after transcatheter aortic valve implantation: a meta-analysis.Ann Thorac Surg. 2015; 99: 809-816
- Sex differences in mortality after transcatheter aortic valve replacement for severe aortic stenosis.J Am Coll Cardiol. 2012; 60: 882-886
- Sex-specific outcomes of transcatheter aortic valve replacement with the SAPIEN 3 valve: insights from the Partner II S3 high-risk and intermediate-risk cohorts.JACC Cardiovasc Interv. 2018; 11: 13-20
- A controlled trial of rivaroxaban after transcatheter aortic-valve replacement.N Engl J Med. 2020; 382: 120-129
- Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: rationale and design of the GALILEO study.Am Heart J. 2017; 184: 81-87
- Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.Eur Heart J. 2012; 33: 2403-2418
- Sex-based differences in outcomes with transcatheter aortic valve therapy: TVT registry from 2011 to 2014.J Am Coll Cardiol. 2016; 68: 2733-2744
- Clinical impact of diabetes mellitus on outcomes after transcatheter aortic valve replacement: insights from the Society of Thoracic Surgeons/American College of Cardiology transcatheter valve therapy registry.Circ Cardiovasc Interv. 2017; 10e005417
- Peripheral artery disease and transcatheter aortic valve replacement outcomes: a report from the Society of Thoracic Surgeons/American College of Cardiology transcatheter therapy registry.Circ Cardiovasc Interv. 2017; 10e005456
- Effects of coronary artery disease in patients undergoing transcatheter aortic valve implantation: a study of age- and gender-matched cohorts.Int J Cardiol. 2017; 243: 150-155
- Long-term outcomes with transcatheter aortic valve replacement in women compared with men: evidence from a meta-analysis.JACC Cardiovasc Interv. 2018; 11: 24-35
- Influence of sex on mortality and perioperative outcomes in patients undergoing TAVR: insights from the FRANCE 2 registry.J Am Coll Cardiol. 2015; 65: 755-757
- One-year outcomes of a European transcatheter aortic valve implantation cohort according to surgical risk.Circ Cardiovasc Interv. 2019; 12e006724
- Future life expectancy in 35 industrialised countries: projections with a Bayesian model ensemble.Lancet. 2017; 389: 1323-1335
- A gender-based analysis of predictors of all cause death after transcatheter aortic valve implantation.Am J Cardiol. 2014; 114: 1269-1274
- Brazilian TAVI Registry investigators. Gender-related differences on short- and long-term outcomes of patients undergoing transcatheter aortic valve implantation.Catheter Cardiovasc Interv. 2017; 89: 429-436
- Revisiting sex equality with transcatheter aortic valve replacement outcomes: a collaborative, patient-level meta-analysis of 11,310 patients.J Am Coll Cardiol. 2015; 66: 221-228
- Sex based analysis of the impact of red blood cell transfusion and vascular or bleeding complications related to TAVI - the TRITAVI-Women Study.Int J Cardiol. 2021; 333: 69-76
- Sex-related differences in outcomes after transcatheter aortic valve implantation: a systematic review and meta-analysis.Circ Cardiovasc Interv. 2013; 6: 543-551
- Frequency, timing, and impact of access-site and non-access-site bleeding on mortality Among patients undergoing transcatheter aortic valve replacement.JACC Cardiovasc Interv. 2017; 10: 1436-1446
- Bleeding and transcatheter aortic valve replacement.J Am Coll Cardiol. 2019; 74: 2768-2770
Article Info
Publication History
Published online: August 04, 2022
Received in revised form:
June 2,
2022
Received:
March 1,
2022
Publication stage
In Press Journal Pre-ProofFootnotes
This work was supported by Bayer AG (Leverkusen, Germany) and Janssen Pharmaceuticals (Beerse, Belgium).
Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifiers: NCT02556203
Identification
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© 2022 Elsevier Inc. All rights reserved.
