The medtech giant presented results from the one-year SMART trial at the American College of Cardiology Annual Scientific Session. It simultaneously published the study results in The New England Journal of Medicine.
SMART evaluated Evolut and Sapien in individuals with aortic stenosis (AS) with small aortic annuli (SAA). It demonstrated noninferior clinical outcomes and superior valve performance (measured by bioprosthetic valve dysfunction performance) for Evolut.
Medtronic said that SMART represents the largest comparative trial of TAVR. It also marks the largest TAVR trial to date to enroll primarily women (87%). SMART randomized and treated 716 patients across more than 80 sites worldwide.
“SMART was launched to better understand how the two most commonly used TAVR systems perform in patients with small aortic annuli, and particularly in women who tend to have smaller heart valves,” said Nina Goodheart, SVP and president, Structural Heart & Aortic, which is part of the Cardiovascular Portfolio at Medtronic. “We continue to develop evidence to better understand the benefits of our Evolut TAVR technology in all patients, including patient populations that are underrepresented, under-diagnosed and under-treated. The results from the SMART trial demonstrate these benefits in a large patient population and reinforce our commitment to driving health equity and engineering the best technology to solve unmet patient needs.”
More on the trial comparing Medtronic and Edwards TAVR systems
According to a news release, women have both TAVR and surgical aortic valve replacement (SAVR) as AS treatment options. However, due to smaller aortic annuli, women can often receive a valve replacement that fails to properly fit their anatomy. This study helps to gather clinical evidence to inform the best treatment approaches.
Eligible patients had a computed tomography aortic valve annulus area of ≤430 mm2. They also presented suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a SAPIEN 3/3 Ultra valve.
“As clinicians, we know that tailored approaches are needed to address the unique presentation of AS in the small annulus patient population, which is primarily women. Little comparative data exists to help us with valve selection,” said Dr. Howard C. Herrmann of the Perelman School of Medicine at the University of Pennsylvania and lead investigator of the SMART trial. “While we know women have a greater benefit than men when treated with TAVR vs SAVR, now for the first time there is definitive data demonstrating that women have the best valve performance when treated with the Evolut TAVR system.”
Results demonstrated that Evolut TAVR met both co-primary endpoints of clinical non-inferiority and hemodynamic superiority at one year.
“Medtronic is committed to providing clinicians and patients with aortic stenosis long-term data to help to inform their treatment decisions,” said Dr. Jeffrey Popma, VP and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business at Medtronic. “Our prior studies have shown an important link between valve performance, mortality, and re-hospitalization at five years.”
Medtronic plans to follow all SMART patients out to five years. It wants to assess the relationship between better valve performance and improved clinical outcomes in patients with small annuli.
What did analysts have to say?
BTIG analysts Marie Thibault and Sam Eiber reported that investors “largely expected” the study results. However, they expressed their surprise at the magnitude of the statistically significant superiority related to bioprosthetic valve dysfunction.
“We think the SMART results will generate buzz and discussion but that large market share shifts are unlikely,” the analysts wrote. “We would expect that as with any trial results, any shifts are likely to be smaller and more gradual as doctors do their own diligence and centers consider their protocols.”
The analysts maintained a “Neutral” rating for Edwards and claimed that Sapien sales reps “will need to be on the defensive and in front of doctors over the coming weeks to combat [Medtronic’s] competitive messaging.”
