Table 5.
Clinical outcomes and safety endpoints.
| Evolut PRO (N = 60) | Evolut R (N = 56) | p value | |
|---|---|---|---|
| Mortality | |||
| Prior to discharge | 0 | 0 | — |
| 30 days | 0 | 0 | — |
| Myocardial infarction | 0 | 0 | — |
| Stroke | |||
| Ischemic | 1 (1.7) | 1 (1.8) | 0.96 |
| Hemorrhagic | 1 (1.7) | 0 | 0.33 |
| Vascular complications | |||
| Major | 3 (5.0) | 3 (5.4) | 0.93 |
| Minor | 3 (5.0) | 7 (12.5) | 0.15 |
| Percutaneous closure—device failure | 0 (3.3) | 0 | 0.17 |
| Bleeding | |||
| Life-threatening | 2 (3.3) | 0 | 0.17 |
| Major | 1 (1.7) | 2 (3.6) | 0.52 |
| Acute kidney injury | |||
| Stage 1 | 3 (5.0) | 8 (14.3) | 0.09 |
| Stage 2 | 0 | 2 (3.6) | 0.14 |
| Stage 3 | 1 (1.7) | 1 (1.8) | 0.96 |
| Embolization/migration | 0 | 0 | — |
| Endocarditis | 0 | 0 | — |
| Valve thrombosis | 0 | 0 | — |
| Coronary artery obstruction | 0 | 0 | — |
| Early safety at 30 days | 56 (93.3) | 53 (94.6) | 0.76 |
| New LBBB | 21/57 (36.8) | 23/52 (44.2) | 0.43 |
| New PPM requirement | 13/47 (27.7) | 15/48 (31.3) | 0.70 |
Values are n or n/N (%). The group of patients with pre-existing LBBB or PPM was excluded for comparison.