Table 3.
Safety endpoints | n (%) |
---|---|
48‐h all‐cause mortality | 0 (0%) |
30‐day all‐cause mortality | 1 (0.4%) |
48‐h MAE composite | 3 (1.2%) |
Device‐related death | 0 (0%) |
Major bleeds (none were intracerebral hemorrhages) | 3 (1.2%) |
Intraprocedural device‐ or procedure‐related adverse events | 0 (0%) |
Clinical deterioration | 0 (0%) |
Device‐related pulmonary vascular injuries | 0 (0%) |
Device‐related cardiac injuries | 0 (0%) |
30‐day SAE (device‐related) | 0 (0%) |
Note: Numbers vary from 247 for 48‐h data to 242 for 30‐day data.
Abbreviations: numbers (n), major adverse events (MAE), serious adverse events (SAE).