Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial
Toff WD., Hildick-Smith D., Kovac J., Mullen MJ., Wendler O., Mansouri A., Rombach I., Abrams KR., Conroy SP., Flather MD., Gray AM., MacCarthy P., Monaghan MJ., Prendergast B., Ray S., Young CP., Crossman DC., Cleland JGF., de Belder MA., Ludman PF., Jones S., Densem CG., Tsui S., Kuduvalli M., Mills JD., Banning AP., Sayeed R., Hasan R., Fraser DGW., Trivedi U., Davies SW., Duncan A., Curzen N., Ohri SK., Malkin CJ., Kaul P., Muir DF., Owens WA., Uren NG., Pessotto R., Kennon S., Awad WI., Khogali SS., Matuszewski M., Edwards RJ., Ramesh BC., Dalby M., Raja SG., Mariscalco G., Lloyd C., Cox ID., Redwood SR., Gunning MG., Ridley PD.
Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P