Bleeding outcomes in the gastrointestinal cancer subgroup in randomized controlled trials comparing DOACs with dalteparin for acute cancer-associated VTE
| Trials . | Hokusai-VTE Cancer34 . | Select-D35 . | ADAM-VTE32 . | Caravaggio31 . | CASTA-DIVA33 . |
|---|---|---|---|---|---|
| Total N | 1046 | 406 | 300 | 1155 | 158 |
| DOACs | Edoxaban | Rivaroxaban | Apixaban | Apixaban | Rivaroxaban |
| GI cancer | 305 (29.2) | 177 (43.6) | 105 (35) | 375 (32.5) | 46 (29.1) |
| Upper GI cancer | 54 (5.2) | 41 (10.1) | 11 (3.7) | 54 (4.7) | 3 (1.9) |
| Major bleeding (DOAC vs dalteparin) | 21/165 (12.7) vs 5/140 (3.6) HR 4.0 (95% CI, 1.5-10.6) | 8/91 (8.8) vs 5/86 (5.8) | 0/48 (0) vs 0/57 (0) | 9/188 (4.8) vs 9/187 (4.8) | NR |
| CRNMB (DOAC vs dalteparin) | NR | 7/91 (7.7) vs 1/86 (1.2) | NR | 19/188 (10.1) vs 7/187 (3.7) | NR |
| Trials . | Hokusai-VTE Cancer34 . | Select-D35 . | ADAM-VTE32 . | Caravaggio31 . | CASTA-DIVA33 . |
|---|---|---|---|---|---|
| Total N | 1046 | 406 | 300 | 1155 | 158 |
| DOACs | Edoxaban | Rivaroxaban | Apixaban | Apixaban | Rivaroxaban |
| GI cancer | 305 (29.2) | 177 (43.6) | 105 (35) | 375 (32.5) | 46 (29.1) |
| Upper GI cancer | 54 (5.2) | 41 (10.1) | 11 (3.7) | 54 (4.7) | 3 (1.9) |
| Major bleeding (DOAC vs dalteparin) | 21/165 (12.7) vs 5/140 (3.6) HR 4.0 (95% CI, 1.5-10.6) | 8/91 (8.8) vs 5/86 (5.8) | 0/48 (0) vs 0/57 (0) | 9/188 (4.8) vs 9/187 (4.8) | NR |
| CRNMB (DOAC vs dalteparin) | NR | 7/91 (7.7) vs 1/86 (1.2) | NR | 19/188 (10.1) vs 7/187 (3.7) | NR |
Values are presented as number (%) unless otherwise indicated.
CRNMB, clinically relevant nonmajor bleeding; NR, not reported.