Table 1.
Study | Age (years) mean ± SD |
Male sex n (%) |
DOACs drug | Comparator | Follow-up (months) |
Cancer patients (%) | Main efficacy outcome | Main safety outcome | Phase | Study design | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Type | Name | Year | ||||||||||
Thromboprophylaxis | MAGELLAN [24] | 2013 | NR | NR | Rivaroxaban | Enoxaparin | 3 months | 7.3% | Composite of asymptomatic proximal DVT, symptomatic proximal or distal DVT, symptomatic nonfatal PE, and death from VTE | Clinically relevant bleeding | Phase 3 | Subgroup analysis |
APEX [14] | 2016 | 76.8 ± 9.3 | 240 (48.1) | Betrixaban | Enoxaparin | 1 month | 12.8% | Composite of asymptomatic proximal DVT, symptomatic proximal or distal DVT, symptomatic nonfatal PE, or fatal PE | Major bleeding | Phase 3 | Subgroup analysis | |
CASSINI [12] | 2019 | 63a | 222 (52.9) | Rivaroxaban | Placebo | 6 months | 100% | Composite of symptomatic or asymptomatic proximal DVT in a lower limb, symptomatic DVT in an upper limb or distal DVT in a lower limb, symptomatic or incidental PE, and death from VTE | Major bleeding | Phase 3 | RCT | |
AVERT [13] | 2019 | 61.2 ± 12.4 | 121 (41.6) | Apixaban | Placebo | 6 months | 100% | VTE | Major bleeding | Phase 3 | RCT | |
Treatment | SELECT-D [16] | 2018 | 67a | 116 (57) | Rivaroxaban | Dalteparin | 24 months | 100% | Recurrent VTE | Major bleeding | Pilot | RCT |
Hokusai VTE Cancer [17] | 2018 | 64.3 ± 11 | 277 (53.1) | Edoxaban | Dalteparin | 12 months | 100% | Recurrent VTE | Major bleeding | Phase 3 | RCT | |
ADAM VTE [7] | 2019 | 64.4 ± 11.3 | 72 (48) | Apixaban | Dalteparin | 6 months | 100% | Recurrent VTE | Major bleeding | Phase 3 | RCT | |
Caravaggio [15] | 2020 | 67.2 ± 11.3 | 292 (50.7) | Apixaban | Dalteparin | 7 months | 100% | Recurrent VTE | Major bleeding | Phase 3 | RCT |
Abbreviations: DOAC direct oral anticoagulant, DVT deep vein thrombosis. PE pulmonary embolism, VTE venous thromboembolism, RCT randomized clinical trial
a Median age