Women represent a particularly challenging population for TAVI, as they often have smaller aortic annuli, greater frailty, and an increased risk of prosthesis-patient mismatch. In this context, the ALL WOMEN study, presented by Ignacio Cruz-Gonzalez during EuroPCR 2026, evaluated for the first time in a randomized trial conducted exclusively in women the hemodynamic outcomes of the supra-annular self-expanding ALLEGRA valve compared with balloon-expandable valves in patients with symptomatic severe aortic stenosis.
The study enrolled 130 women aged 75 years or older, randomized in a 1:1 ratio to receive either ALLEGRA (n=64) or a balloon-expandable valve (n=66) across 12 centers in 4 European countries. The mean age was 83 years, and the STS score was approximately 5% in both groups. The primary endpoint was the difference in the change of mean transvalvular gradient from baseline to 30 days, assessed by echocardiography.
From a procedural standpoint, the ALLEGRA valve required higher rates of predilatation (93.8% vs. 20%; p<0.0001), greater use of post-dilatation (30% vs. 3.1%; p<0.0001), longer procedures, and higher contrast utilization. However, technical success and device success rates were similar between the two strategies.
At 30 days, the mean gradient was significantly lower with ALLEGRA compared with balloon-expandable valves (7.1 ± 2.5 mmHg vs. 11.3 ± 4.6 mmHg; p<0.0001), with an absolute between-group difference of -6.1 mmHg (95% CI: -10.4 to -1.9; p=0.005). In addition, ALLEGRA demonstrated superior overall hemodynamic performance, including lower peak transvalvular velocity and larger effective orifice area.
Moderate or severe prosthesis-patient mismatch occurred in 9.6% of patients treated with ALLEGRA compared with 38.6% of those receiving balloon-expandable valves (p=0.007), with no cases of severe prosthesis-patient mismatch reported in the ALLEGRA group.
Regarding early safety at 30 days, no statistically significant differences were observed in mortality, stroke, bleeding, vascular complications, or the need for permanent pacemaker implantation. However, a numerical trend favoring balloon-expandable valves was observed for the VARC-3 composite safety endpoint (86.4% vs. 71.9%; p=0.069).
Conclusion: Lower Gradients and Less Prosthesis-Patient Mismatch with ALLEGRA
In conclusion, the ALL WOMEN study represents the first randomized trial comparing different TAVI platforms exclusively in women and demonstrated that the supra-annular self-expanding ALLEGRA valve provides significantly superior hemodynamic performance compared with balloon-expandable valves. The results showed lower residual gradients, a larger effective valve area, and a marked reduction in the incidence of prosthesis-patient mismatch, a particularly relevant finding in women with small aortic annuli. These findings reinforce the potential benefit of supra-annular platforms in optimizing hemodynamic performance in this specific patient population.
Original Title: ALL WOMEN: Multicenter randomized clinical trial ALLEGRA vs balloon-expandable valve in Women.
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