Study characteristics of major pivotal trials comparing DOAC with LMWH.
Hokusai VTE Cancer | SELECT-D | ADAM VTE | CARAVAGGIO | |
---|---|---|---|---|
Trial design | Non-inferiority phase 3 | Pilot | Superiority phase 3 | Non-inferiority phase 3 |
Sample size | 1,046 | 406 | 287 | 1,155 |
DOAC arm | LMWH for 5 days then edoxaban 60 mg/day PO | Rivaroxaban 15 mg PO twice a day for 21 days, then 20 mg PO once a day | Apixaban 10 mg PO twice a day for 7 days, then 5 mg PO twice a day | Apixaban 10 mg PO twice a day for 7 days, then 5 mg PO twice a day |
LMWH arm | Dalteparin 200 U/kg daily for 1 month followed by 150 U/kg daily | |||
Dose reduction of DOAC | Edoxaban 30 mg/day PO in patients with <60 kg of body weight; creatinine clearance 30–50 mL/min; drug-to-drug interactions | N/A | N/A | N/A |
Treatment duration | 12 months | 6 months | 6 months | 6 months |
Type of qualifying VTE | Acute symptomatic or incidentally detected lower extremity proximal DVT or PE of segmental or more proximal pulmonary artery | Acute symptomatic lower extremity proximal DVT, symptomatic PE, or incidental PE | Acute lower extremity or upper extremity DVT, PE, splanchnic vein, or cerebral vein thrombosis | Acute symptomatic or incidentally detected lower extremity proximal DVT or PE of segmental or more proximal pulmonary artery |
Cancer excluded | Basal cell/squamous cell cancer of the skin | Basal cell/squamous cell cancer of the skin | Basal cell/squamous cell cancer of the skin | Basal cell/squamous cell cancer of the skin |
Esophageal or gastroesophageal cancer | Primary brain tumor | |||
Intracerebral metastasis | ||||
Acute leukemia | ||||
Primary outcome | Composite of recurrent VTE or major bleeding | Recurrent VTE | Major bleeding | Recurrent VTE |
Major bleeding |