New data from largest head-to-head randomized control TAVR trial demonstrates non-inferior clinical outcomes and superior valve performance for Evolut TAVR compared to Sapien™ at one year
"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
In addition to being the largest comparative trial of TAVR, SMART is also the largest TAVR trial to date to enroll primarily women (87%). Symptomatic severe aortic stenosis can be fatal if left untreated and the average patient survival is two years without treatment.1 Despite women's longer life expectancy, once impacted by severe aortic stenosis they suffer from higher mortality than men, even after matching for age.2 Both TAVR and surgical aortic valve replacement (SAVR) are options for women to treat AS. Due to their smaller aortic annuli, women can often receive a valve replacement that does not properly fit their anatomy ” highlighting the need for clinical evidence to inform the best treatment approaches.3 Additionally, despite prevalence of chronic conditions associated with AS in women over 65, a new survey of over 1,000 women announced today found that the majority have never been referred to a cardiologist.
"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
The SMART Trial is an international, prospective, multi-center, randomized (1:1) post-market trial comparing the safety and performance of self-expanding versus balloon-expandable TAVR in patients with symptomatic severe AS and SAA. The trial randomized and treated 716 patients, 87% of which were women, across more than 80 sites worldwide. Eligible patients had a computed tomography aortic valve annulus area of ‰¤430 mm2 and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a SAPIEN 3™/3 Ultra™ valve.
"For patients with heart valve replacements, early bioprosthetic valve dysfunction can lead to increased risk of serious long term outcomes including mortality and rehospitalization," added
Results demonstrated that the Evolut TAVR platform met both co-primary endpoints of clinical non-inferiority and hemodynamic superiority at one year.
- Evolut TAVR met non-inferiority for the clinical outcome primary endpoint, a composite of all-cause mortality, disabling stroke, or heart failure rehospitalization at one year (9.4% Evolut vs. 10.6% SAPIEN, p
- Evolut TAVR demonstrated superiority for the valve function primary endpoint, bioprosthetic valve dysfunction through one year (9.4% Evolut vs. 41.6% SAPIEN, p
"Medtronic is committed to providing clinicians and patients with aortic stenosis long-term data to help to inform their treatment decisions," said
Analyst and Investor Briefing
Medtronic will host an analyst and investor briefing to discuss the results from the SMART Trial on Sunday, April 7, 2024, at 10:45 AM EDT. The briefing will feature remarks from Medtronic management, immediately followed by answering questions from institutional investors and equity analysts. A live, listen-only webcast will be available and can be accessed by clicking on the Events link at investorrelations.medtronic.com on April 7. An archived replay will be available on the same webpage later in the day. This event is not part of the official ACC Scientific Sessions.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin,
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation (NYSE:EW).
1Carabello BA, Paulus WJ. Aortic stenosis. Lancet.
2Am Heart Assoc. 2021;10:e018816. DOI: 10.1161/JAHA.120.018816.
3Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest.
Contact:
Ryan Weispfenning
Investor Relations
+1-763-505-4626
Kimberly Powell
Public Relations
+1-202-498-2601