Adjudicated clinical outcomes at 30 days follow-up
| Early generation TAVI devices | Newer generation TAVI devices | Newer generation vs early generation | ||
| Crude | ||||
| n=391 | n=391 | HR (95% CI) | P value | |
| 30-day follow-up | ||||
| Early safety composite end point, n (%) | 83 (21.2) | 81 (20.8) | 0.98 (0.72 to 1.33) | 0.876 |
| All-cause death, n (%) | 19 (4.9) | 15 (3.9) | 0.80 (0.41 to 1.58) | 0.519 |
| Cardiovascular death, n (%) | 18 (4.6) | 11 (2.8) | 0.62 (0.29 to 1.31) | 0.210 |
| CVE, n (%) | 17 (4.4) | 17 (4.4) | 1.00 (0.51 to 1.97) | 0.989 |
| Stroke | 16 (4.1) | 15 (3.9) | 0.94 (0.47 to 1.91) | 0.868 |
| Disabling stroke | 14 (3.6) | 9 (2.3) | 0.64 (0.28 to 1.49) | 0.301 |
| Non-disabling stroke | 2 (0.5) | 6 (1.6) | 3.05 (0.61 to 15.09) | 0.172 |
| Transient ischaemic attack | 1 (0.3) | 2 (0.5) | 2.02 (0.18 to 22.25) | 0.567 |
| Myocardial infarction, n (%) | 2 (0.5) | 2 (0.5) | 1.00 (0.14 to 7.10) | 1.000 |
| All-cause death or CVE, n (%) | 26 (6.7) | 29 (7.5) | 1.13 (0.66 to 1.91) | 0.661 |
| Cardiovascular death or CVE, n (%) | 25 (6.4) | 26 (6.7) | 1.05 (0.61 to 1.81) | 0.867 |
| Bleeding events, n (%) | 125 (32.0) | 96 (24.8) | 0.74 (0.57 to 0.97) | 0.028 |
| Life-threatening or disabling bleeding | 33 (8.5) | 18 (4.6) | 0.54 (0.30 to 0.96) | 0.036 |
| Major bleeding | 71 (18.2) | 42 (10.8) | 0.58 (0.39 to 0.85) | 0.005 |
| Minor bleeding | 27 (7.0) | 39 (10.1) | 1.46 (0.90 to 2.39) | 0.128 |
| Vascular access site and access-related complications, n (%) | 97 (24.8) | 93 (23.9) | 0.96 (0.72 to 1.27) | 0.757 |
| Major vascular complications | 42 (10.7) | 47 (12.1) | 1.12 (0.74 to 1.70) | 0.587 |
| Minor vascular complications | 55 (14.1) | 44 (11.3) | 0.80 (0.54 to 1.18) | 0.260 |
| Permanent pacemaker implantation | 84 (21.7) | 89 (23.2) | 1.08 (0.80 to 1.45) | 0.617 |
| Acute kidney injury, n(%) | 27 (6.9) | 17 (4.4) | 0.63 (0.34 to 1.16) | 0.138 |
| Stage 1, n (%) | 18 (4.6) | 2 (0.5) | 0.11 (0.03 to 0.48) | 0.003 |
| Stage 2, n (%) | 0 (0.0) | 5 (1.3) | 11.00 (0.61 to 198.26) | 0.062 |
| Stage 3, n (%) | 9 (2.3) | 10 (2.6) | 1.12 (0.46 to 2.76) | 0.800 |
CVE, cerebrovascular event; TAVI, transcatheter aortic valve implantation.