Medtronic plc announced new data from the largest head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (TAVR), were presented as a late breaking clinical trial at the American College of Cardiology Annual Scientific Session and simultaneously published in The New England Journal of Medicine. The one-year results of the SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial in individuals with aortic stenosis (AS) with small aortic annuli (SAA) demonstrated noninferior clinical outcomes and superior valve performance as measured by bioprosthetic valve dysfunction performance for the Evolut? TAVR platform compared to the SAPIEN?

platform. 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. 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.