LB-9
Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annuli: Additional Outcomes from the SMART Trial
Presenter
Howard C. Herrmann, M.D., MSCAI, Hospital of the University of Pennsylvania, Philadelphia, PA, PA
Howard C. Herrmann, M.D., MSCAI, Hospital of the University of Pennsylvania, Philadelphia, PA, PA, Didier Tchetche, MD, Clinique Pasteur, Toulouse, France and Roxana Mehran, M.D., MSCAI, Icahn School of Medicine at Mount Sinai, New York, NY
Keywords: Structural Heart Disease (SHD) and TAVI/TAVR/Aortic Valve
Background:
The Small Annuli Randomized To Evolut or SAPIEN trial (SMART trial; NCT04722250) compares the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with severe aortic stenosis (AS) and small aortic annuli (SAA). These patients, typically female and often underrepresented in clinical trials, are at risk for impaired valvular hemodynamics and associated adverse cardiovascular outcomes following TAVR.
Methods:
SMART is an international, prospective, multi-center, randomized (1:1) post-market trial comparing safety and performance of self-expanding valves (SEV) versus balloon-expandable valves (BEV) in TAVR patients with symptomatic severe AS and SAA (funded by Medtronic Inc.). Eligible patients had an aortic valve annulus area of ≤430 mm2 by CT and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a SAPIEN 3/3 Ultra valve. The primary endpoints were: (1) a clinical outcome composite of mortality, disabling stroke, or heart failure rehospitalization, and (2) a valve function composite of bioprosthetic valve dysfunction (BVD) through 12 months. Powered secondary endpoints include: (1) BVD in females; (2) hemodynamic structural valve dysfunction; (3) hemodynamic mean gradient; and (4) effective orifice area, all at 12 months; and (5) moderate or severe prosthesis-patient mismatch at 30 days. Patients will be followed for 5 years.
Results:
A total of 716 patients (87% women, mean age 80 years) were treated at 83 sites. Data collection is complete and the primary outcomes and secondary endpoints at 1 year will be presented for the first time at ACC 2024. Additional subgroup analyses based on comorbidities will be presented at SCAI 2024.
Conclusions:
SMART is the first prospective, randomized, powered, head-to-head trial of SEVs versus BEVs in TAVR patients with SAA and the largest trial to enroll primarily women. The results will help physicians select the best TAVR device in this challenging patient population.