Table 2:
Clinical outcomes at 30 days and 1 year
| Outcome [n (%)] | TAVI (n = 73) | 30 days AVR (n = 35) | PTAV/medical (n = 55) | P-value | TAVI (n = 73) | 1 year AVR (n = 35) | PTAV/medical (n = 55) | P-value |
|---|---|---|---|---|---|---|---|---|
| Death | ||||||||
| From any cause | 7 (10) | 6 (17) | 7 (13) | 0.54 | 15 (21) | 7 (20) | 21 (38) | 0.051 |
| From cardiovascular cause | 5 (7) | 2 (6) | 7 (13) | 0.40 | 6 (8) | 3 (9) | 18 (33) | <0.001 |
| Repeat hospitalization for cardiovascular cause | 1 (1) | 0 | 0 | 0.54 | 9 (12) | 1 (3) | 10 (18) | 0.098 |
| Death or repeat hospitalization | 8 (11) | 6 (17) | 6 (11) | 0.62 | 21 (29) | 8 (23) | 24 (44) | 0.080 |
| Stroke or TIA | ||||||||
| All | 3 (4) | 3 (9) | 1 (2) | 0.31 | 9 (12) | 3 (9) | 3 (5) | 0.41 |
| TIA | 1 (1) | 0 | 0 | 0.54 | 3 (4) | 0 | 0 | 0.15 |
| Stroke | ||||||||
| Minor | 0 | 1 (3) | 0 | 0.16 | 3 (4) | 1 (3) | 2 (4) | 0.95 |
| Major | 2 (3) | 2 (6) | 1 (2) | 0.57 | 3 (4) | 2 (6) | 1 (2) | 0.62 |
| Death or major stroke | 9 (12) | 7 (20) | 6 (11) | 0.44 | 17 (23) | 8 (23) | 22 (40) | 0.081 |
| Major vascular complications | 3 (4) | 0 | 1 (2) | 0.41 | 4 (5) | 0 | 2 (4) | 0.37 |
| Life-threatening bleeding | 14 (19) | 18 (51) | NA | <0.001 | – | – | – | – |
| Acute kidney injury | ||||||||
| Modified RIFLE stage 2 or 3 | 11 (15) | 3 (9) | 9 (16) | 0.56 | – | – | – | – |
| Renal replacement therapy | 4 (5) | 2 (6) | 0 | 0.21 | – | – | – | – |
| Cardiac reintervention | ||||||||
| PTAV | 0 | 0 | 1 (2) | 0.38 | 0 | 0 | 2 (4) | 0.14 |
| AVR | 1 (1) | 0 | 0 | 0.54 | 2 (3) | 0 | 0 | 0.29 |
| Endocarditis | 0 | 0 | 0 | – | 1 (1) | 0 | 0 | 0.54 |
| New atrial fibrillation | 10 (14) | 12 (34) | 3 (5) | 0.001 | 10 (14) | 12 (34) | 3 (5) | 0.001 |
| New pacemaker | 7 (10) | 2 (6) | 2 (4) | 0.40 | 8 (11) | 2 (6) | 2 (4) | 0.27 |
| VARC device success | 67 (92) | 32 (91) | NA | 0.95 | – | – | – | – |
| VARC combined safety at 30 days | 21 (29) | 22 (63) | NA | 0.001 | – | – | – | – |
| VARC combined efficacy at 1 year | – | – | – | – | 16/66 (24) | 3/29 (10) | NA | 0.12 |
AVR: surgical aortic valve replacement; PTAV: percutaneous transluminal aortic valvuloplasty; TAVI: transcatheter aortic valve implantation; TIA: transient ischaemic attack; VARC combined safety and efficacy endpoints refer to composite endpoints unfavourably affecting safety or efficacy, respectively, and are defined by the VARC (see Methods and definitions).