Table 4.
Summary of adverse events/complications
| Event |
CLOSURE Trial |
PC Trial |
RESPECT Trial |
|||
|---|---|---|---|---|---|---|
| Closure | Medical therapy | Closure | Medical therapy | Closure | Medical therapy | |
|
Major vascular procedural complication (%) |
3.2 |
NA |
1.5 |
NA |
0.6 |
NA |
|
Atrial fibrillation (%) |
5.7 |
0.7 |
2.9 |
1.0 |
3.0 |
1.5 % |
|
Major bleeding episode (%) |
2.6 |
1.1 |
3.9 |
5.7 |
1.6 |
1.9 |
|
Death other than end point (%) |
0.5 |
0.9 |
NA |
NA |
NA |
NA |
|
Nervous system disorder (%) |
1.5 |
3.5 |
NA |
NA |
NA |
NA |
|
PFO-related hospital admission (%) |
NA |
NA |
6.4 |
6.2 |
NA |
NA |
|
Dizziness (%) |
NA |
NA |
0.5 |
1.9 |
NA |
NA |
|
Seizure (%) |
NA |
NA |
0.5 |
1.4 |
NA |
NA |
|
Dyspnea (%) |
NA |
NA |
0 |
1.9 |
NA |
NA |
|
Chest pain (%) |
NA |
NA |
1.5 |
1.9 |
NA |
NA |
| Allergic drug reaction (%) | NA | NA | 0.5 | 1.0 | 0.2 | NA |