Women-Only Trial Supports Self-Expanding TAVR as the Way to Go

Transcatheter aortic valve replacement (TAVR) with a self-expanding valve still worked out better, at least in terms of hemodynamics, in the first head-to-head device trial exclusively in women.

Among older women with symptomatic severe calcific aortic stenosis (AS) in the ALL WOMEN study, TAVR resulted in mean gradients falling by 40.9 mmHg from baseline to 30 days with the Allegra valve, a larger drop than the 34.8 mmHg with a balloon-expandable valve (P=0.005), reported Ignacio Cruz-Gonzalez, MD, PhD, of University Hospital of Salamanca in Spain.

Resulting 30-day gradients were 7.1 and 11.3 mmHg, respectively (P<0.0001), between the self-expanding and balloon-expandable valve groups in this 130-person trial. Effective orifice area and patient-prosthesis mismatch (PPM) results also significantly favored the Allegra group, Cruz-Gonzalez reported at the EuroPCR meeting in Paris.

Cruz-Gonzalez noted special considerations for female TAVR candidates, namely their typically worse outcomes, underdiagnosis of aortic stenosis and underrepresentation in landmark trials, as well as their typically smaller annuli, smaller vessels, and increased frailty. With smaller annuli, operators can expect a higher risk of elevated postprocedural gradients and PPM.

The ALL WOMEN results thus align with that of the female-majority SMART trial, which had shown better hemodynamics — albeit no substantial clinical benefit yet — at 1 year after TAVR with a supra-annular, self-expanding Evolut TAVR valve versus an intra-annular, balloon-expandable Sapien valve in people with a small annulus.

At this year’s EuroPCR, the SMART investigators also provided their 3-year report. The verdict: still better hemodynamic measures with Evolut, though that has yet to translate into improved clinical outcomes over Sapien. The composite primary endpoint of mortality, disabling stroke, or heart failure rehospitalization reached 25.4% and 22.6% for the Evolut and Sapien groups, respectively, a difference that was not statistically significant (P=0.44).

It could be a matter of waiting, as some had said they expected the event curves to separate between 2 and 4 years at the time of the 1-year report. Another comparison is planned at 5 years, said SMART co-author Howard Herrmann, MD, of the University of Pennsylvania in Philadelphia.

Herrmann highlighted the greater incidence of bioprosthetic valve dysfunction with Sapien valves at 3 years in SMART (54.4% vs 16.3%, P<0.001), particularly prosthetic valve thrombosis (5.8% vs 1.3%, P=0.002). Evolut valves in the study, on the other hand, maintained larger effective orifice areas, lower mean gradients, and greater Doppler velocity index measures throughout the range of annulus area.

What’s more, three times as many Sapien recipients showed PPM at 30 days as their Evolut peers (33.2% vs 9.9%), and the link between PPM and mortality was significant for the entire TAVR cohort in SMART.

ALL WOMEN “truly aligns with SMART” and the key question going forward will be whether hemodynamic benefit of the self-expanding valves can be linked to improved outcomes, suggested Thomas Cuisset, MD, PhD, of Hopital La Timone in Marseille, France, at a press conference.

“Adverse hemodynamics are not a good thing,” Herrmann stressed. As for when the clinical benefit of the self-expanding valve should come to fruition in SMART, he suggested “the next 2 years,” and possibly evident in the primary composite endpoint or an individual endpoint such as cardiovascular mortality.

SMART was conducted in 13 countries and included TAVR patients with severe symptomatic AS and a small aortic valve annulus. There were 716 people treated, with over 85% women and an average age just over 80 years; average aortic annulus size was just over 380 mm² in both groups.

For ALL WOMEN, investigators sought women with symptomatic severe calcific AS with no prior valve implantation or severe left ventricular systolic dysfunction. There were 130 participants randomized in Europe; this group had a mean age about 83 years and an aortic annulus area just under 370 mm² on average.

Successful valve implantation was achieved in 96.9% of the Allegra group and 100% of the balloon-expandable valve group.

Safety results were not significantly different between groups.

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