TAVR superior to surgery at 1 year for women with severe aortic stenosis: RHEIA
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Key takeaways:
- The RHEIA trial included enrolled-only women randomly assigned to transcatheter vs. surgical aortic valve replacement.
- TAVR was superior to surgery for death, stroke or rehospitalization at 1 year.
Women with symptomatic severe aortic stenosis had better outcomes at 1 year after transcatheter aortic valve replacement with a balloon-expandable valve compared with women who underwent surgery, according to new data from the RHEIA trial.
At 1 year, the primary composite endpoint of death, stroke or rehospitalization was reported in 15.6% of women who underwent surgical AVR compared with 8.9% who underwent TAVR (HR = 0.55; 95% CI, 0.34-0.88; P for noninferiority < .001; P for superiority = .03). The difference between groups met the criteria for both noninferiority and superiority in favor of TAVR, Hélène Eltchaninoff, MD, head of the department of cardiology at University Hospital of Rouen, France, said during a press conference at the European Society of Cardiology Congress.
“This superiority was essentially driven by the lower rate of rehospitalizations,” Eltchaninoff said.
TAVR vs. surgery in women
The RHEIA trial, which was conducted at 48 sites in 12 countries, enrolled women with symptomatic severe aortic stenosis (mean age, 73 years; 100% white; mean STS score, 2.1-2.2). At baseline, about one-quarter of women had diabetes, more than one-third had NYHA class III or IV HF, 19% had coronary disease and 3% had prior stroke. Eltchaninoff said women presented with a typical pattern of aortic stenosis, with a mean aortic valve gradient of 47 mm Hg. Seventy percent to 75% of women had a small annulus (annular area < 430 mm2).
Women (n = 443) were randomly assigned to undergo TAVR with a balloon-expandable valve (Sapien 3 or Sapien 3 Ultra, Edwards Lifesciences) or surgical AVR with any commercially available surgical valve.
Looking at individual components of the primary outcome at 1 year, death occurred in 0.9% of the TAVR group compared with 2% of the surgery group (P = .44). Stroke was similar at 3.3% vs. 3%, respectively (P = .1).
The rates of rehospitalization at 1 year, for a valve- or procedure-related event or worsening congestive HF, was twofold lower in the TAVR group (4.8% vs. 11.4%; P = .02), Eltchaninoff said.
With regard to other key secondary endpoints at 1 year, more women assigned TAVR required a new permanent pacemaker (8.8% vs. 2.9%; P = .01), whereas new-onset AF was more common in the surgery group (3.3% vs. 28.8%; P < .001). Major vascular complications occurred in 3.3% of the TAVR group compared with 0.5% of the surgery group (P = .07).
Ninety percent of patients were discharged directly to home after TAVR compared with half of patients after surgery. Mean hospital stay was twofold lower in the TAVR group, at 4 days compared with 9 days, according to the results.
In terms of echocardiography findings, Eltchaninoff said “overall performance was excellent in both groups at 1 year,” with a slight difference in favor of surgery for mean gradient (11.7 mm Hg vs. 14.3 mm Hg; P < .001) and for effective orifice area (1.8 cm2 vs. 1.74 cm2; P = .01).
‘Preferred therapy’ in women?
Women present with a number of differences in baseline characteristics compared with men, from more fibrotic valves to smaller annuli, Eltchaninoff said during the Hot Line presentation.
Recent data suggest that the risk for mortality after AVR is higher with surgery and lower with TAVR in women compared with men, she said. However, women remain underrepresented in low-risk TAVR vs. surgery trials, she said.
“A randomized clinical trial [was] needed to confirm the benefit of TAVI over surgery in women,” Eltchaninoff said during the presentation.
These findings come on the heels of data from the PARTNER trials and the SMART trial, which were previously reported by Healio.
“In women with symptomatic severe aortic stenosis, TAVR using balloon-expandable devices could be considered the preferred therapy,” Eltchaninoff said during the presentation.
The researchers noted several limitations of the RHEIA trial, including a limited number of patients enrolled; exclusion of women with unicuspid, bicuspid or noncalcified valves; long recruitment period; and concomitant procedures performed in 13% of women overall.
Additionally, the RHEIA looked at outcomes with a third-generation balloon-expandable valve system and the results cannot be extrapolated to other valve types, Eltchaninoff said.
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Eltchaninoff H, et al. Hot line 5. Presented at: European Society of Cardiology Congress; Aug. 30-Sept. 2, 2024; London (hybrid meeting).
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