(a).
Serious adverse events | Placebo (n = 20) | ASC (n = 40) | P value |
---|---|---|---|
Death | 0 (0) | 1 (2.5) | 1.00 |
Hospitalizations | |||
Myocardial infarction | 1 (5) | 1 (2.5) | 1.00 |
Dyspnea | 0 (0) | 1 (2.5) | 1.00 |
Anemia | 1 (5) | 1 (2.5) | 1.00 |
Syncope | 1 (5) | 0 (0) | 0.33 |
Peripheral edema | 0 (0) | 1 (2.5) | 1.00 |
Angina worsening | 3 (15) | 6 (15) | 1.00 |
Pneumonia | 1 (5) | 1 (2.5) | 1.00 |
NOGA-related complications | |||
Pericardial effusion | 0 (0) | 1 (2.5) | 1.00 |
ECG changes—SA-block, NsVT | 2 (10) | 1 (2.5) | 0.26 |
Hematoma at femoral puncture | 1 (5) | 0 (0) | 0.33 |
Allergic reaction | 0 (0) | 1 (2.5) | 1.00 |
Bradycardia | 0 (0) | 1 (2.5) | 1.00 |
General discomfort | 0 (0) | 1 (2.5) | 1.00 |
NsVT: nonsustained ventricular tachycardia; SA-block: sinoatrial block. Values are n (%); P values are calculated using Fischer's exact test.