Dr. Yusuf Bozkurt Şahin

Name of the Study: Transcatheter vs. Surgical Aortic Valve Replacement in Women: A Pooled Analysis of the RHEIA and PARTNER 3 Trials

Published in Congress: TCT 2024

Link: https://www.tctmd.com/news/pooled-all-female-analysis-support-benefits-tavi-over-savr

Background:
Aortic stenosis (AS) presents substantial health risks, especially in symptomatic female patients. Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are effective treatments for AS; however, data on comparative outcomes in women remain limited. Women face a unique set of anatomical and clinical challenges that can affect their response to treatment, with often delayed diagnosis and treatment. The RHEIA and PARTNER 3 trials provide the most comprehensive data in this context, evaluating one-year clinical and echocardiographic outcomes in women receiving either TAVR or SAVR.

Objective:
This study aims to evaluate the efficacy and safety of TAVR compared to SAVR specifically in women with severe symptomatic AS, focusing on the primary composite endpoint of all-cause mortality, stroke, or rehospitalization at one year. Additional objectives include analyzing secondary endpoints such as valve hemodynamics, rehospitalization rates, and incidence of procedural complications by annular size and age.

Methods:
Data from the RHEIA and PARTNER 3 trials were pooled to provide a robust sample size, exclusively focusing on female patients. Women were randomized to receive either TAVR with the balloon-expandable SAPIEN 3 or SAPIEN 3 Ultra valve (Edwards Lifesciences) or SAVR with any approved surgical valve. A total of 712 women with symptomatic severe AS were included, with 376 undergoing TAVR and 336 SAVR. Follow-up was conducted at 30 days and one year. Baseline characteristics, clinical endpoints, and echocardiographic measures were carefully monitored and analyzed.
Primary Endpoint: The composite outcome of all-cause death, stroke, or rehospitalization at one year served as the primary endpoint, examining any differences based on treatment modality (TAVR vs. SAVR).
Secondary Endpoints: Composite of all-cause death and all stroke, all-cause death, all stroke, rehospitalization related to the valve, procedure, or congestive heart failure.

Results:

1. Primary Outcome: TAVR showed a significantly lower rate of the primary composite endpoint compared to SAVR (8.5% vs. 16.8%, p<0.001). This difference was mainly driven by a reduced rehospitalization rate for TAVR (5.4% for TAVR vs. 11.9% for SAVR, p=0.002).

2. Secondary Outcomes:
• Disabling Stroke: TAVR demonstrated a trend toward a lower rate of disabling stroke at one year compared to SAVR.
• Mortality: No statistically significant difference was observed in all-cause mortality between the TAVR and SAVR groups (0.5% vs. 0.3%).
• Echocardiographic Outcomes: Both TAVR and SAVR groups exhibited favorable hemodynamic results, with low mean gradients and excellent paravalvular leak profiles. More than 99% of patients in both groups had none/trace or mild paravalvular regurgitation at both 30 days and one year.
• Atrial Fibrillation and Major Bleeding: New-onset atrial fibrillation and major bleeding were significantly more common in the SAVR group (atrial fibrillation: 23.6% vs. 4.0%; major bleeding: 16.7% vs. 3.5%).

3. Subgroup Analyses: Outcomes were assessed by age and annular size, with TAVR showing consistent benefit across these subgroups. Notably, there was no interaction effect between annular size or age and the primary outcome, supporting TAVR’s effectiveness regardless of these factors.

According to NYHA functional classifications, the majority of patients who underwent TAVR or surgery were assessed as Class I or II at 30 days and one-year post-procedure. Notably, a significant improvement in quality and functional life scores (KCCQ) was observed in the TAVR group.

Conclusion:

The findings of this pooled analysis support TAVR as a preferable option over SAVR in women with severe symptomatic AS, given its association with a reduced risk of rehospitalization and comparable rates of mortality and stroke. TAVR may thus represent the optimal initial therapeutic approach for elderly women with symptomatic AS, particularly when considering the reduced procedural risks and quicker recovery times associated with the transcatheter approach.

Interpretations:

This is the largest female-specific analysis to date, addressing a significant gap in understanding gender-specific outcomes in AS treatment. These results have important implications for clinical practice, suggesting that TAVR may offer a safer and more effective alternative to SAVR in elderly women with severe AS. However, long-term follow-up and additional research are needed to fully assess the durability and extended outcomes of TAVR in this population.