Table 3 Safety outcomes at one-year follow-up
Safety outcomes | Group 1 (n = 1125) | Group 2 (n = 1043) | p Value |
|---|---|---|---|
Thromboembolic events | 0.037 | ||
Ischemic stroke | 15 (1.3%) | 8 (0.8%) | |
Transient ischemic attack | 10 (0.9%) | 12 (1.2%) | |
Systemic embolism | 10 (0.9%) | 8 (0.8%) | |
Cardiac complications | 0.211 | ||
Myocardial Infarction | 8 (0.7%) | 10 (1.0%) | |
Heart failure exacerbation | 12 (1.1%) | 10 (1.0%) | |
Ventricular arrhythmias | 5 (0.4%) | 7 (0.7%) | |
Procedural complications | 0.087 | ||
Vascular access complications | 15 (1.3%) | 12 (1.2%) | |
Hemorrhage | 8 (0.7%) | 10 (1.0%) | |
Pneumothorax | 2 (0.2%) | 4 (0.4%) |