Clinical events occurring in the investigated patients
| Events . | Patients treated with 2.5 mg BID apixaban (positive D-dimer), n = 446, FU 533 y . | Patients who stopped treatment (negative D-dimer), n = 286, FU 336 y . | P value . |
|---|---|---|---|
| Primary outcomes, n % (95% CI) (Including VTE recurrences and MB; no death could be attributed to VTE) | 5 (4 males) | 21 (14 males) | — |
| Incidence per 100 person-years (95% CI) | |||
| Primary outcomes | 0.9 (0.3-2.2) | 6.2 (3.9-9.5) | <.0001 |
| MB | 0.3 (0-1.3) | 0.6 (0-2.1) | — |
| CRNMB | 1.1 (0.4-2.4) | 0 | — |
| Primary outcomes and arterial events | 1.7 (0.8-3.2) | 6.5 (4.1-9.9) | .0002 |
| Recurrent VTE, n | |||
| DVT | 2 | 10 | — |
| Isolated PE | 1 | 9 | — |
| DVT + PE | 0 | 0 | — |
| Deaths for VTE∗ | 0 | 0 | — |
| MB, n† | 2 | 2 | — |
| Other outcomes, n | |||
| Arterial vascular event, n‡ | 4 (1 death) | 1 | — |
| Isolated distal DVT, n | 2 | 5 | — |
| SVT, n | 1 | 13 | — |
| CRNMB, n | 6 | 0 | — |
| Minor bleeds, n | 21§ | 0 | — |
| Retinal vein occlusion | 1 | 0 | — |
| Patients with duration of follow-up <18 moǁ | 184 | 127 | — |
| Events . | Patients treated with 2.5 mg BID apixaban (positive D-dimer), n = 446, FU 533 y . | Patients who stopped treatment (negative D-dimer), n = 286, FU 336 y . | P value . |
|---|---|---|---|
| Primary outcomes, n % (95% CI) (Including VTE recurrences and MB; no death could be attributed to VTE) | 5 (4 males) | 21 (14 males) | — |
| Incidence per 100 person-years (95% CI) | |||
| Primary outcomes | 0.9 (0.3-2.2) | 6.2 (3.9-9.5) | <.0001 |
| MB | 0.3 (0-1.3) | 0.6 (0-2.1) | — |
| CRNMB | 1.1 (0.4-2.4) | 0 | — |
| Primary outcomes and arterial events | 1.7 (0.8-3.2) | 6.5 (4.1-9.9) | .0002 |
| Recurrent VTE, n | |||
| DVT | 2 | 10 | — |
| Isolated PE | 1 | 9 | — |
| DVT + PE | 0 | 0 | — |
| Deaths for VTE∗ | 0 | 0 | — |
| MB, n† | 2 | 2 | — |
| Other outcomes, n | |||
| Arterial vascular event, n‡ | 4 (1 death) | 1 | — |
| Isolated distal DVT, n | 2 | 5 | — |
| SVT, n | 1 | 13 | — |
| CRNMB, n | 6 | 0 | — |
| Minor bleeds, n | 21§ | 0 | — |
| Retinal vein occlusion | 1 | 0 | — |
| Patients with duration of follow-up <18 moǁ | 184 | 127 | — |
BID, bis intraday; CRNMB, clinically relevant nonmajor bleeding; FU, follow-up; MB, major bleeding; SVT, superficial vein thrombosis.
No death could be attributed to VTE.
Two MB events in the patients receiving apixaban and 1 in patients off anticoagulant treatment were posttraumatic.
The 4 arterial events occurring in patients receiving apixaban were 2 acute myocardial infarctions, 1 stroke, and 1 sudden death attributed to a cardiovascular cause; the arterial event occurring in patients with negative D-dimer was a peripheral arterial thrombosis.
The minor bleeds occurred in 14 patients.
Patients with lower than established follow-up because of the premature interruption of the study.