Sex-specific outcomes after TAVR and SAVR: Key takeaways from a new meta-analysis
Transcatheter aortic valve replacement (TAVR) is associated with certain early benefits for women not seen with surgical aortic valve replacement (SAVR), according to a new meta-analysis published in JACC: Advances.[1] These benefits were primarily seen in intermediate- and high-risk patients—and they weren’t seen at all when treating men.
“As TAVR expands to younger and lower-risk populations, clarifying sex-specific and time-dependent outcomes is critical for individualized valve selection,” wrote first author Hendrianus Hendrianus, MD, a researcher with Chung-Ang University in South Korea, and colleagues.
The group explored data from nine different randomized controlled trials (RCTs) comparing TAVR and SAVR. Studies were required to include sex-stratified outcomes to be counted as part of this meta-analysis. The nine RCTs included more than 9,500 patients with severe aortic stenosis who were randomized to undergo TAVR or SAVR. Approximately 44% of all patients were women. The primary outcomes for these trials were slightly different from one another, but they all included all-cause mortality as a key component.
After one year, TAVR was linked to a 33% relative reduction in the risk of the trial-defined endpoint for women. This was largely driven by improvements for intermediate- and high-risk patients. This trend was not seen in men.
After two years, this same trend persisted. At five years, however, the “early benefit of TAVR observed in women was no longer evident.”
“Risk-stratified analyses at five years showed no significant differences between TAVR and SAVR in low surgical-risk patients for either or men,” the authors wrote. “In contrast, among intermediate–high surgical-risk patients, long-term outcomes favored SAVR, driven primarily by men, whereas outcomes in women were directionally similar but not statistically significant.”
Hendrianus et al. also noted that self-expanding and balloon-expandable TAVR valves were linked with comparable five-year outcomes after both TAVR and SAVR.
“Across all time points, tests for subgroup differences were not statistically significant, suggesting no clear evidence that valve type modified the sex-specific treatment effect,” they wrote.
These early benefits for women were likely driven by multiple factors, the authors explained. Women undergoing SAVR often present with more comorbidities, for example, and they may face certain risks that can be “mitigated with a less invasive approach.”
Sex-related differences when it comes to ventricular remodeling, vascular compliance and overall recovery may also play a role in this trend.
“Consistent with this, valve platform–stratified analyses showed similar sex-specific patterns across self-expanding and balloon-expandable valves, with no significant interaction,” the authors wrote. “Although effect sizes in women were numerically greater in balloon-expandable trials at some time points, this did not translate into a significant difference, suggesting that these effects are unlikely to be device-driven.”
The group emphasized that these data represent another reminder of the importance of making treatment decisions on a case-by-case basis. TAVR may offer “meaningful early and mid-term advantages” for certain female patients, for example, but not for men.
“Importantly, these findings do not support a sex-based treatment mandate, but instead reinforce the need for shared decision-making that integrates patient sex, surgical risk, anatomical characteristics, comorbidity burden, life expectancy and patient preferences,” the authors concluded.
Click here to read the full analysis in JACC: Advances, an American College of Cardiology publication.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.