Table 3

Clinical Outcomes in the As-Treated Population

Index Hospitalization or 30 Days1 Year
TAVRSAVRp ValueTAVRSAVRp Value
Major, life threatening, or disabling bleeding16 (11.3)28 (20.9)0.03
Cardiogenic shock6 (4.2)14 (10.4)0.05
Major vascular complications8 (5.6)2 (1.5)0.10
Acute kidney injury stage II or III1 (0.7)9 (6.7)0.01
All-cause death3 (2.1)5 (3.7)0.437 (4.9)10 (7.5)0.38
 Cardiovascular death3 (2.1)5 (3.7)0.436 (4.3)10 (7.5)0.25
Neurological events4 (2.8)4 (3.0)0.947 (5.0)8 (6.2)0.68
 Stroke2 (1.4)4 (3.0)0.374 (2.9)6 (4.6)0.44
 Transient ischemic attack2 (1.4)0 (0)0.173 (2.1)2 (1.6)0.71
MI4 (2.8)8 (6.0)0.205 (3.5)8 (6.0)0.33
Valve endocarditis1 (0.7)0 (0)0.334 (2.9)2 (1.6)0.47
New-onset or worsening AF24 (16.9)77 (57.8)<0.00130 (21.2)79 (59.4)<0.001
Permanent pacemaker implantation46 (34.1)2 (1.6)<0.00151 (38.0)3 (2.4)<0.001

Values are n (%).

Abbreviations as in Table 1.

  • Rate during index hospitalization; data reported as number of patients with events (percentage) in each treatment group; p values were calculated by Fisher exact test or chi-square test, as appropriate.

  • Rates determined at 30 days and 1 year; data reported as number of subjects (Kaplan-Meier estimates) at the specific time point, and they do not equal the number of patients with events divided by the total number of patients in each treatment group; p values were calculated by the log-rank test for all data through 30 days or 1 year.