TAVR outperforms SAVR when treating women, historic all-female trial confirms
Transcatheter aortic valve replacement (TAVR) is associated with better one-year outcomes for women than surgical aortic valve replacement (SAVR), according to new findings presented at ESC Congress 2024 in London.
The RHEIA trial, funded by Edwards Lifesciences, included data from 443 women who underwent TAVR at one of 48 European facilities. It is believed to be the first TAVR trial of this size to exclusively enroll female patients. The Medtronic-funded SMART trial, presented at ACC.24 in April, included 87% women.
The average age for RHEIA was 73 years old. Patients were randomized to either undergo TAVR with an Edwards Lifesciences Sapien 3 or Sapien 3 Ultra valve or SAVR.
Overall, the study’s primary endpoint—death, stroke or rehospitalization after one year—was seen in 8.9% of TAVR patients and 15.6% of SAVR patients.
“Women are an underrepresented group in the diagnosis and treatment of severe aortic stenosis (AS) and this landmark study provides important insights into their treatment options,” principal investigator Hélène Eltchaninoff, MD, head of the department of cardiology at the University Hospital of Rouen in France, said in a statement. “The transcatheter and surgical arms achieved remarkable results and the performance of the transcatheter valves adds to a growing body of evidence on the treatment options available to women.”
“We are proud of this high-quality clinical research to inform patients’ decisions about the treatment of their heart valve failure,” added Larry Wood, an Edwards corporate vice president and the company’s group president of TAVR and surgical structural heart.
Medtronic even issued a comment on the RHEIA results, emphasizing that SMART and other similar studies have consistently linked TAVR with encouraging outcomes for women and other patients with small aortic annuli.
“At Medtronic, we recognize the importance of clinical studies in helping to foster revolutionary change that advances medicine and patient care,” the company said. “We are committed to developing life-transforming technology that is grounded in sound evidence and appreciate the RHEIA Trial investigators for their work in advancing women’s cardiovascular health.”
TAVR continues to deliver strong outcomes
This analysis represents just the latest example of TAVR’s continued momentum as go-to treatment option for patients severe AS. One recent study published in the Journal of the American Heart Association, for example, found that complications after TAVR are down dramatically in recent years, even outperforming the positive progress seen in SAVR outcomes.
Another recent analysis, this one published in The American Journal of Cardiology, included data from three well-known clinical trials: NOTION, Evolut Low Risk and PARTNER 3. The study’s authors concluded that TAVR and SAVR are linked to comparable long-term outcomes among low-risk patients with severe AS.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.