Objective
to compare the safety and efficacy of the ACURATE neo (self-expanding TAVR prothesis) with the SAPIEN 3 TAVR prothesis (balloon expandable) for the treatment of symptomatic severe aortic stenosis
Study
investigator-initiated, multicentre non-inferiority, randomised trial (margin 7.7%)
Population
patients aged 75 or older with symptomatic severe aortic stenosis at increased surgical risk
Endpoints
all cause death, any stroke, severe bleeding, major vascular complications, coronary artery obstruction, acute kidney injury, rehospitalisation (for valve-related symptoms or heart failure) and valve-related dysfunction at 30 days
Conclusion
the self-expanding ACURATE neo was not non-inferior compared to balloon-expandable SAPIEN 3
Lanz et al. Lancet. 2019;394:1619-28
