Randomized research in women all comers with Aortic Stenosis

The RHEIA trial found that women who had a minimally invasive procedure - called transcatheter aortic valve implantation (TAVI) - had better outcomes than those who had open heart surgery. Results particularly showed that women who received TAVI were less likely to have to return to hospital during the year following their procedure, compared to women who had surgery.*

Other differences between the two procedures were:

• Shorter stay in hospital – women who received TAVI were in hospital for four days compared to nine days for those undergoing surgery.
• More likely to return directly home – nine out of ten women who had TAVI were well enough to be discharged from the hospital to their home or to a self-care facility, rather than a nursing home, compared to just half of those who had surgery.
• Quicker return to daily life – after 30 days, women who received TAVI had higher scores on a quality-of-life questionnaire compared to those who had surgery, indicating that they were more likely to feel well, be able to socialize, and do their usual activities.

A link to the full research paper will be available here shortly after publication.

* Eltchaninoff H. RHEIA transcatheter vs surgical aortic valve replacement in women. ESC 2024. Hotline 5

The purpose of this trial is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgery in female patients with severe symptomatic aortic stenosis.

• First female only RCT in severe symptomatic aortic stenosis
• First RCT with Sapien 3 ULTRA
• First randomized trial to include low flow / low gradient patients
• First trial to include all-comer irrespective of risk

Prospective, randomized, controlled, multi-center study. Qualified study patients will be randomized 1:1 to receive either transcatheter aortic valve implantation with SAPIEN 3 or SAPIEN 3 Ultra through iliofemoral access, or SAVR with any commercially available bioprosthetic valve.

Female all comers with severe symptomatic Aortic Stenosis eligible for both treatment options (SAVR / TAVI):

• Any surgical risk
• Including low flow / low gradient
• 440 patients to be enrolled, 220 into each cohort
• Min. 2 patients / month / center
• Each patient candidate to be approved by Case Review Committee prior randomization

Clinical efficacy composite endpoint at 1 year:

• All-cause mortality
• All stroke (disabling and non-disabling)
• Rehospitalization (valve-related or procedure-related or worsening congestive heart failure)

RHEIA is a Randomized Clinical Trail driven as Investigator Initiated Trial funded by a research grant from Edwards Lifesciences.

SSS International Clinical Research is acting as the Sponsor and coordinating clinical research organization.