Clinical outcomes at 24 months for patients with moderately-severe AS and severe AS
Moderately-severe AS (n=113) | Severe AS (n=1301) | |||||
TAVR (n=66) | SAVR (n=47) | P value | TAVR (n=664) | SAVR (n=637) | P value | |
All-cause mortality or disabling stroke | 5 (7.7) | 3 (6.5) | 0.82 | 26 (4.0) | 39 (6.3) | 0.05 |
All-cause mortality | 3 (4.6) | 2 (4.4) | 0.95 | 22 (3.3) | 27 (4.4) | 0.32 |
Reintervention | 1 (1.5) | 0 (0.0) | 0.40 | 5 (0.8) | 5 (0.8) | 0.91 |
All stroke and TIA | 8 (12.6) | 2 (4.3) | 0.15 | 52 (7.9) | 49 (8.0) | 0.99 |
Bleed | 6 (9.5) | 3 (6.4) | 0.62 | 70 (10.6) | 88 (14.0) | 0.05 |
Life-threatening or disabling | 3 (4.7) | 2 (4.3) | 0.96 | 28 (4.2) | 61 (9.7) | <0.001 |
Major bleed | 3 (4.8) | 1 (2.1) | 0.49 | 42 (6.4) | 33 (5.3) | 0.42 |
Major vascular complication | 2 (3.0) | 1 (2.1) | 0.77 | 26 (3.9) | 23 (3.6) | 0.78 |
Acute kidney injury | 2 (3.0) | 5 (10.6) | 0.10 | 13 (2.0) | 64 (10.1) | <0.001 |
Myocardial infarction | 1 (1.6) | 2 (4.3) | 0.37 | 15 (2.3) | 9 (1.4) | 0.27 |
Valve endocarditis | 0 (0.0) | 0 (0.0) | NA | 3 (0.5) | 6 (1.0) | 0.26 |
Valve thrombosis | 1 (1.5) | 0 (0) | 0.40 | 1 (0.2) | 1 (0.2) | 0.96 |
Valve thrombosis (subclinical) | 0 (0.0) | 0 (0.0) | NA | 4 (0.6) | 3 (0.5) | 0.78 |
Permanent pacemaker implant* | 19 (30.1) | 1 (2.1) | <0.001 | 134 (20.3) | 52 (8.3) | <0.001 |
Permanent pacemaker implant† | 19 (30.5) | 1 (2.3) | <0.001 | 134 (21.0) | 52 (8.6) | <0.001 |
Atrial fibrillation | 6 (9.2) | 14 (29.9) | 0.003 | 79 (12.0) | 255 (40.3) | <0.001 |
Coronary artery obstruction | 1 (1.5) | 0 (0.0) | 0.40 | 5 (0.8) | 2 (0.3) | 0.28 |
Composite event‡ | 9 (13.8) | 4 (8.7) | 0.42 | 61 (9.2) | 102 (16.2) | <0.001 |
Data shown as number of patients with an event (%), where Kaplan-Meier estimates are provided as percentages. The corresponding p values were calculated by the log-rank test for all data through 24 months.
*Subjects with pacemaker or implantable cardioverter defibrillator (ICD) at baseline are included.
†Subjects with pacemaker or ICD at baseline are excluded.
‡Composite event includes all-cause mortality, disabling stroke, life threatening or disabling bleeding, major vascular complication, acute kidney injury stage 2 or 3.
AS, aortic stenosis; NA, not available; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; TIA, transient ischaemic attack.