Table 3: Clinical events during clinical follow-up in patients with successful implantation.
Events | All (N = 78) | Men (N = 41) | Women (N = 37) | p-value |
Death | 19 (24.4%) | 8 (19.5%) | 11 (29.7%) | 0.225 |
Stroke | 5 (6.4%) | 4 (9.8%) | 1 (2.7%) | 0.362 |
Systemic embolism | 0 | 0 | 0 | |
Bleeding | 16 (20.5%) | 9 (22.0%) | 7 (18.9%) | 0.692 |
Gastrointestinal bleeding | 12 (15.4%) | 7 (17.1%) | 5 (13.5%) | 0.625 |
Intracranial hemorrhage | 0 | 0 | 0 | |
Other bleeding | 4 (5.1%) | 2 (4.9%) | 2 (5.4%) | 0.925 |
Severe/significant bleeding* | 14 (17.9%) | 7 (17.1%) | 7 (18.9%) | 0.882 |
*Defined as "need for admission", "need for transfusion" or "intracranial hemorrhage" or reduction in Hb > 3 g/dl.