In the first-ever randomized controlled trial of younger patients, TAVI did not reach the prespecified noninferiority threshold.
PARIS — Despite some potential advantages, transcatheter aortic valve implantation failed to meet the primary prespecified threshold for noninferiority to surgical aortic valve replacement in younger low-risk patients with severe disease in a multicenter randomized trial.
"There are many studies comparing TAVI to surgical aortic valve replacement, but these have largely enrolled older patients — typically 75 years or at least 70 years or older — and they have generally excluded those with bicuspid valve stenosis," De Backer said. For the secondary endpoints,"there were a couple of wins for TAVI and a couple of wins for surgery," De Backer said.
Even though the NOTION-2 investigators expected that transcatheter aortic valve replacement would be noninferior to surgery in younger patients overall, the major message is that"TAVI outcomes in young bicuspid aortic stenosis patients are less favorable," according to De Backer.
Cardiac Surgery Stroke Cerebrovascular Accident CVA - Cerebrovascular Accident Thromboembolism Surgery Transcatheter Aortic Valve Replacement TAVR Transcatheter Aortic Valve Implantation TAVI Percutaneous Aortic Valve Replacement Hypertension Congenital Heart Disease Aortic Valve Valve Replacement Atrial Fibrillation AF Afib A-Fib Afib Afib Atrial Fib
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