SMART: Self-Expanding vs.

Balloon-

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 Expandable Valve For TAVR in Patients With
Small Valve Annulus
Apr 07, 2024
ACC News Story
The supra-annular self-expanding Evolut PRO/PRO+/FX TAVR device was found to be
superior for valve function and noninferior for clinical outcomes at one year
compared to the balloon-expandable SAPIEN 3/3 Ultra TAVR device, according to the
results of the SMART trial, presented during a Late-Breaking Clinical Trial Session at
ACC.24  and published simultaneously in the New England Journal of Medicine  .

The trial, conducted at 83 international sites across North America, Europe and the
Middle East, randomly assigned 716 patients (mean age 80 years, 87% women) who
underwent TAVR and had a valve annulus ≤430 mm2 to either the self-expanding
Evolut valve or the balloon-expandable SAPIEN valve. Participants were considered to
face a low to intermediate risk, with a mean Society of Thoracic Surgeons Predicted
Risk of Mortality of 3.3%.

Results at one year showed that there was no significant between-group di!erence in
the primary composite endpoint of death, disabling stroke or rehospitalization for
heart failure – which occurred in 9.4% of patients who received the Evolut valve and
10.6% of those receiving the SAPIEN valve (p<0.001). For the co-primary endpoint of
valve function, defined in terms of a composite of structural and nonstructural valve
deterioration, blood clotting around the valve, infection of the valve and aortic valve
reintervention, the Evolut device was found to be superior; the endpoint occurred in
9.4% of patients who received the Evolut valve and 41.6% of those receiving the
SAPIEN valve (p<0.001).

All prespecified secondary endpoints were statistically significant in favor of the self-
expanding valve, including blood pressure across the valve and the size of the valve
opening. The aortic valve mean gradient at 12 months was 7.7 mm Hg with the self-
expanding valve and 15.7 mm Hg with the balloon-expandable valve.

"Clinically, at one year, either valve is reasonable, and the results are pretty similar,
although mild valve leaks and some measures of quality of life were better with
Evolut," said Howard C. Herrmann, MD, FACC, lead author of the study.
"Furthermore, this is the first time we get to identify di!erences between the devices
that might impact later patient outcomes."

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 Similar results were seen across all subgroups, although the researchers plan to
analyze additional subgroups to determine whether valve performance or clinical
outcomes may vary among people in di!erent age groups or among people with
di!erent comorbidities or annulus size. They also plan to assess measures of valve
durability over time, which Herrmann said is becoming more important as younger
patients are increasingly undergoing TAVR. Researchers will continue to track
outcomes over the next five years.

This was the first trial to focus specifically on informing device selection for patients
with small aortic annuli, a patient group that is primarily women and has been
underrepresented in previous clinical trials for TAVR. "We think it's important to study
this population, which represents up to 40% of all patients getting TAVR, and it's
important to study women, who make up the majority of the small annulus
population," said Herrmann.

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Keywords: ACC Annual Scientific Session, ACC24, Valvular Diseases, Coronary, Peripheral, and
Structural Procedures

Related Content
ACC.24 Meeting Coverage

Small Annuli Randomized to Evolut or SAPIEN Trial

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Last Updated April 2024

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