TAVR could be ‘preferred therapeutic option’ over surgery for women
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Key takeaways:
- Researchers analyzed outcomes among only women who underwent TAVR or surgery.
- TAVR was superior to surgery for the primary composite outcome of death, stroke or rehospitalization at 1 year.
WASHINGTON — Women with symptomatic severe aortic stenosis had better 1-year outcomes after transcatheter aortic valve replacement vs. surgery, according to a pooled analysis of only women in the PARTNER 3 low-risk and RHEIA trials.
“We report the largest all-female analysis in symptomatic severe aortic stenosis patients exploring the relative treatment effects of TAVR with the balloon-expandable Sapien 3 or Sapien 3 Ultra system compared with surgery with any commercially available valve,” Didier Tchetche, MD, interventional cardiologist and head of the structural heart disease program at Clinique Pasteur in Toulouse, France, said during a press conference at TCT 2024.
There are limited data on differences in outcomes among women with severe aortic stenosis who undergo TAVR compared with surgery, according to Tchetche. The RHEIA trial, previously reported by Healio, enrolled only women; in the PARTNER 3 low-risk trial, women comprised 32.5% of participants assigned to undergo TAVR and 28.9% assigned to surgery. Both trials examined the same primary composite endpoint — all-cause death, stroke or rehospitalization — in addition to other clinical outcomes, and also shared a common echo core lab, Tchetche said. Pooling data from the RHEIA and PARTNER 3 would yield increased power to assess differences in outcomes and potentially guide clinical decision-making, he said.
Outcomes at 1 year
The pooled analysis included 712 women with symptomatic severe aortic stenosis who were randomly assigned in either trial to undergo TAVR with the Sapien 3 or Sapien 3 Ultra (Edwards Lifesciences) balloon-expandable valves (n = 376) or surgical AVR with any commercially available surgical valve (n = 336). Mean age was 73 years, BMI 30 kg/m2, Society of Thoracic Surgeons score 2.1, EuroSCORE II 1.7% and CT annular area 407 mm2. About one-third had NYHA class III or IV HF, one-fifth had CAD and one-quarter had diabetes.
At 1-year follow-up, the rate of the primary composite endpoint of death, stroke and rehospitalization was lower with TAVR compared with surgery (8.5% vs. 16.8%; P < .001), according to the results. This finding was driven primarily by lower rehospitalization rates in the TAVR group (5.4% vs. 11.9%; P = .002), Tchetche said. There was no difference between the groups in other individual components of the primary outcome.
Additional analysis revealed no effect of treatment type on outcomes according to annular size or age, the researchers reported.
Similarly, low rates of aortic valve reintervention, endocarditis and thrombosis were observed at 1 year in both groups, Tchetche said. One-year rates of new-onset atrial fibrillation (4% vs. 23.6%) and life-threatening or major bleeding (3.5% vs. 16.7%) were higher in the surgery group. More women who underwent TAVR required a new permanent pacemaker at 1 year (6.8% vs. 5%), according to the results.
“Excellent, if not exceptional” hemodynamics and echocardiographic assessments were observed with both procedures up to 1 year of follow-up, Tchetche said. Ninety-nine percent of women had none/trace or mild paravalvular aortic regurgitation at 30 days and 1 year and 30-day mean gradients were low and sustained out to 1 year, according to the presentation.
Important to focus on women
During a discussion after the press conference, Anna Sonia Petronio, MD, professor and head of the catheterization laboratory at University of Pisa, Italy, said it is important to focus on women, noting that “women have a small annulus [and] it is not easy to go for surgery for a person with a small annulus.”
The importance of this trial, Petronio said, is that “TAVR is a good option — probably the best one — for an elderly woman.”
“In women with symptomatic severe aortic stenosis, TAVR using balloon-expandable devices could be the preferred therapeutic option over surgery,” Tchetche said during the press conference.
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Tchetche D, et al. Late-breaking clinical science: Session II, in collaboration with the Journal of the American College of Cardiology. Presented at: TCT Scientific Symposium; Oct. 27-30, 2024; Washington, D.C. (hybrid meeting).
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