For a study, researchers sought to determine if TAVI was a good alternative to surgery for individuals with a relatively high surgical risk. Between April 2014 and April 2018, 913 patients aged 70 and older with severe, symptomatic aortic stenosis and substantially elevated surgical risk due to age or comorbidities were included in this randomized clinical study, which was done in 34 locations and followed up until April 2019. TAVI employs any CE-marked valve, access method (n = 458), or surgical aortic valve replacement (n = 455). All-cause mortality at one year was the main endpoint. The primary hypothesis was that TAVI was non-inferior to surgery, with a noninferiority margin of 5% for the absolute between-group difference in mortality for the upper limit of the 1-sided 97.5% CI. Duration of hospital stay, significant bleeding events, vascular complications, conduction abnormality necessitating pacemaker insertion, and aortic regurgitation were among the 36 secondary outcomes (30 described herein).
About 912 (99.9%) of the 913 randomized patients (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%]) completed follow-up and were included in the noninferiority analysis. At one year, the TAVI group had 21 deaths (4.6%), and the surgical group had 30 deaths (6.6%), with an adjusted absolute risk difference of 2.0% (1-sided 97.5% CI, to 1.2%; P<.001 for noninferiority). The 30 prespecified secondary outcomes presented herein one year revealed no meaningful change. TAVI was linked to considerably less post-procedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At one year, there were significantly fewer major bleeding events after TAVI compared to surgery (7.2% vs. 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]), but significantly more vascular complications (10.3% vs. 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). TAVI was non-inferior to surgery in terms of all-cause mortality at 1 year in patients aged 70 years or older with severe, symptomatic aortic stenosis and somewhat elevated operational risk.