| . | All patients (N = 633) . | Women (N = 209) . | Men (N = 424) . | P-value . |
|---|---|---|---|---|
| Primary outcomea | ||||
| Primary endpoint: composite all-cause death, stroke, or major bleeding | 45 (7.1%) | 19 (9.1%) | 26 (6.1%) | 0.19 |
| Death | 2 (0.3%) | 1 (0.5%) | 1 (0.2%) | 0.61 |
| Stroke or TIA | 2 (0.3%) | 0 | 2 (0.5%) | 0.32 |
| Major bleeding (BARC 2–5) | 42 (6.6%) | 19 (9.1%) | 23 (5.4%) | 0.09 |
| BARC 2: bleeding requiring medical attention | 21 (3.3%) | 12 (5.7%) | 9 (2.1%) | 0.03 |
| BARC 3a: haemoglobin drop of 30 to <50 g/L or requiring transfusion | 9 (1.4%) | 3 (1.4%) | 6 (1.4%) | 0.98 |
| BARC 3b: haemoglobin drop >50 g/L, or requiring surgery or iv vasoactive agents, or cardiac tamponade | 11 (1.7%) | 3 (1.4%) | 8 (1.9%) | 0.68 |
| BARC 3c: intracranial haemorrhage | 1 (0.2%) | 1 (0.5%) | 0 | 0.15 |
| TIMI major bleeding (intracranial bleed or bleeding resulting in haemoglobin drop of ≥50 g/L, or bleeding resulting in death within 7 days) | 4 (0.6%) | 2 (1.0%) | 2 (0.5%) | 0.47 |
| ISTH major bleeding | 24 (3.8%) | 11 (5.3%) | 13 (3.1%) | 0.19 |
| Cardiac tamponade | 7 (1.1%) | 2 (1.0%) | 5 (1.2%) | 0.80 |
| Secondary outcomes | ||||
| Cardiovascular hospitalization, n (%) | 136 (21.5%) | 53 (25.4%) | 83 (19.6%) | 0.10 |
| Nights spent in hospital during follow-up, median (q1–q3) | 3 (2–6) n = 105 | 3 (2–7) n = 39 | 3 (1–5) n = 66 | 0.16 |
| Recurrent AF | 185/619 (29.9) | 71/207 (34.3) | 114/412 (27.7) | 0.09 |
| One time | 69 (11.1) | 27 (13.0) | 42 (10.2) | |
| Several times | 87 (14.1) | 35 (16.9) | 52 (12.6) | |
| Still in AF | 29 (4.7) | 9 (4.4) | 20 (4.9) |
| . | All patients (N = 633) . | Women (N = 209) . | Men (N = 424) . | P-value . |
|---|---|---|---|---|
| Primary outcomea | ||||
| Primary endpoint: composite all-cause death, stroke, or major bleeding | 45 (7.1%) | 19 (9.1%) | 26 (6.1%) | 0.19 |
| Death | 2 (0.3%) | 1 (0.5%) | 1 (0.2%) | 0.61 |
| Stroke or TIA | 2 (0.3%) | 0 | 2 (0.5%) | 0.32 |
| Major bleeding (BARC 2–5) | 42 (6.6%) | 19 (9.1%) | 23 (5.4%) | 0.09 |
| BARC 2: bleeding requiring medical attention | 21 (3.3%) | 12 (5.7%) | 9 (2.1%) | 0.03 |
| BARC 3a: haemoglobin drop of 30 to <50 g/L or requiring transfusion | 9 (1.4%) | 3 (1.4%) | 6 (1.4%) | 0.98 |
| BARC 3b: haemoglobin drop >50 g/L, or requiring surgery or iv vasoactive agents, or cardiac tamponade | 11 (1.7%) | 3 (1.4%) | 8 (1.9%) | 0.68 |
| BARC 3c: intracranial haemorrhage | 1 (0.2%) | 1 (0.5%) | 0 | 0.15 |
| TIMI major bleeding (intracranial bleed or bleeding resulting in haemoglobin drop of ≥50 g/L, or bleeding resulting in death within 7 days) | 4 (0.6%) | 2 (1.0%) | 2 (0.5%) | 0.47 |
| ISTH major bleeding | 24 (3.8%) | 11 (5.3%) | 13 (3.1%) | 0.19 |
| Cardiac tamponade | 7 (1.1%) | 2 (1.0%) | 5 (1.2%) | 0.80 |
| Secondary outcomes | ||||
| Cardiovascular hospitalization, n (%) | 136 (21.5%) | 53 (25.4%) | 83 (19.6%) | 0.10 |
| Nights spent in hospital during follow-up, median (q1–q3) | 3 (2–6) n = 105 | 3 (2–7) n = 39 | 3 (1–5) n = 66 | 0.16 |
| Recurrent AF | 185/619 (29.9) | 71/207 (34.3) | 114/412 (27.7) | 0.09 |
| One time | 69 (11.1) | 27 (13.0) | 42 (10.2) | |
| Several times | 87 (14.1) | 35 (16.9) | 52 (12.6) | |
| Still in AF | 29 (4.7) | 9 (4.4) | 20 (4.9) |
Number of patients with available information is given when patients had missing values.
AF, atrial fibrillation; BARC, Bleeding Academic Research Consortium; ISTH, International Society on Thrombosis and Haemostasis; TIA, transient ischaemic attack; TIMI, thrombolysis in myocardial infarction bleeding classification.
Number of patients per group are shown. Some patients had more than one event.
| . | All patients (N = 633) . | Women (N = 209) . | Men (N = 424) . | P-value . |
|---|---|---|---|---|
| Primary outcomea | ||||
| Primary endpoint: composite all-cause death, stroke, or major bleeding | 45 (7.1%) | 19 (9.1%) | 26 (6.1%) | 0.19 |
| Death | 2 (0.3%) | 1 (0.5%) | 1 (0.2%) | 0.61 |
| Stroke or TIA | 2 (0.3%) | 0 | 2 (0.5%) | 0.32 |
| Major bleeding (BARC 2–5) | 42 (6.6%) | 19 (9.1%) | 23 (5.4%) | 0.09 |
| BARC 2: bleeding requiring medical attention | 21 (3.3%) | 12 (5.7%) | 9 (2.1%) | 0.03 |
| BARC 3a: haemoglobin drop of 30 to <50 g/L or requiring transfusion | 9 (1.4%) | 3 (1.4%) | 6 (1.4%) | 0.98 |
| BARC 3b: haemoglobin drop >50 g/L, or requiring surgery or iv vasoactive agents, or cardiac tamponade | 11 (1.7%) | 3 (1.4%) | 8 (1.9%) | 0.68 |
| BARC 3c: intracranial haemorrhage | 1 (0.2%) | 1 (0.5%) | 0 | 0.15 |
| TIMI major bleeding (intracranial bleed or bleeding resulting in haemoglobin drop of ≥50 g/L, or bleeding resulting in death within 7 days) | 4 (0.6%) | 2 (1.0%) | 2 (0.5%) | 0.47 |
| ISTH major bleeding | 24 (3.8%) | 11 (5.3%) | 13 (3.1%) | 0.19 |
| Cardiac tamponade | 7 (1.1%) | 2 (1.0%) | 5 (1.2%) | 0.80 |
| Secondary outcomes | ||||
| Cardiovascular hospitalization, n (%) | 136 (21.5%) | 53 (25.4%) | 83 (19.6%) | 0.10 |
| Nights spent in hospital during follow-up, median (q1–q3) | 3 (2–6) n = 105 | 3 (2–7) n = 39 | 3 (1–5) n = 66 | 0.16 |
| Recurrent AF | 185/619 (29.9) | 71/207 (34.3) | 114/412 (27.7) | 0.09 |
| One time | 69 (11.1) | 27 (13.0) | 42 (10.2) | |
| Several times | 87 (14.1) | 35 (16.9) | 52 (12.6) | |
| Still in AF | 29 (4.7) | 9 (4.4) | 20 (4.9) |
| . | All patients (N = 633) . | Women (N = 209) . | Men (N = 424) . | P-value . |
|---|---|---|---|---|
| Primary outcomea | ||||
| Primary endpoint: composite all-cause death, stroke, or major bleeding | 45 (7.1%) | 19 (9.1%) | 26 (6.1%) | 0.19 |
| Death | 2 (0.3%) | 1 (0.5%) | 1 (0.2%) | 0.61 |
| Stroke or TIA | 2 (0.3%) | 0 | 2 (0.5%) | 0.32 |
| Major bleeding (BARC 2–5) | 42 (6.6%) | 19 (9.1%) | 23 (5.4%) | 0.09 |
| BARC 2: bleeding requiring medical attention | 21 (3.3%) | 12 (5.7%) | 9 (2.1%) | 0.03 |
| BARC 3a: haemoglobin drop of 30 to <50 g/L or requiring transfusion | 9 (1.4%) | 3 (1.4%) | 6 (1.4%) | 0.98 |
| BARC 3b: haemoglobin drop >50 g/L, or requiring surgery or iv vasoactive agents, or cardiac tamponade | 11 (1.7%) | 3 (1.4%) | 8 (1.9%) | 0.68 |
| BARC 3c: intracranial haemorrhage | 1 (0.2%) | 1 (0.5%) | 0 | 0.15 |
| TIMI major bleeding (intracranial bleed or bleeding resulting in haemoglobin drop of ≥50 g/L, or bleeding resulting in death within 7 days) | 4 (0.6%) | 2 (1.0%) | 2 (0.5%) | 0.47 |
| ISTH major bleeding | 24 (3.8%) | 11 (5.3%) | 13 (3.1%) | 0.19 |
| Cardiac tamponade | 7 (1.1%) | 2 (1.0%) | 5 (1.2%) | 0.80 |
| Secondary outcomes | ||||
| Cardiovascular hospitalization, n (%) | 136 (21.5%) | 53 (25.4%) | 83 (19.6%) | 0.10 |
| Nights spent in hospital during follow-up, median (q1–q3) | 3 (2–6) n = 105 | 3 (2–7) n = 39 | 3 (1–5) n = 66 | 0.16 |
| Recurrent AF | 185/619 (29.9) | 71/207 (34.3) | 114/412 (27.7) | 0.09 |
| One time | 69 (11.1) | 27 (13.0) | 42 (10.2) | |
| Several times | 87 (14.1) | 35 (16.9) | 52 (12.6) | |
| Still in AF | 29 (4.7) | 9 (4.4) | 20 (4.9) |
Number of patients with available information is given when patients had missing values.
AF, atrial fibrillation; BARC, Bleeding Academic Research Consortium; ISTH, International Society on Thrombosis and Haemostasis; TIA, transient ischaemic attack; TIMI, thrombolysis in myocardial infarction bleeding classification.
Number of patients per group are shown. Some patients had more than one event.
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
