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 |