Burden of venous thromboembolism in patients with pancreatic cancer

Table 3 Randomized trials assessing the efficacy and safety of direct oral anticoagulants in cancer patients with venous thromboembolism

	HOKUSAI-CANCER VTE[68] (n = 1050)		SELECT-D[69] (n = 406)		ADAM-VTE[70] (n = 300)		CARAVAGGIO[71] (n = 1155)
	Edoxaban	Dalteparin	Rivaroxaban	Dalteparin	Apixaban	Dalteparin	Apixaban	Dalteparin
Dose	LMWH × 5 d, then 60 mg OD	200 IU/kg × 1 mo, then 150 U/kg daily	15 mg BID × 3 wk, then 20 mg OD × 6mo	200 IU/kg × 1 mo, then 150 U/kg daily	10 mg BID × 7 d, then 5 mg BID × 6 mo	200 IU/kg × 1 mo, then 150 U/kg daily	10 mg BID × 7 d, then 5 mg BID × 6 mo	200 IU/kg × 1 mo, then 150 U/kg daily
Patients	Patients with active cancer and symptomatic or incidental popliteal, femoral or iliac or IVC DVT, symptomatic or incidental PE		Patients with active cancer and symptomatic DVT, symptomatic PE, or incidental PE		Active cancer patients with acute DVT (including upper extremity), PE, splanchnic or cerebral vein thrombosis		Patients with active or recent cancer and acute DVT or PE
PrimaryEndpoint	Composite of recurrent VTE/major bleeding at 12 mo		VTE recurrence over 6 mo		Primary safety: Major bleeding at 6mo; secondary efficacy: VTE at 6 mo		Efficacy: Recurrent VTE at 6 mo; Safety: Major bleeding at 6 mo
Follow-up	12 mo		6 mo		6 mo		6 mo
Recurrent VTE (%)	41/525 (7.9)	59/525 (11.3)	8/203 (4)	18/203 (11)	1/145 (0.7)	9/142 (6.3)	32/576 (5.6)	46/579 (7.9)
HR (95%CI) for recurrent VTE	0.71 (0.48-1.06), P = 0.006		0.43 (0.19-0.99)		0.099 (0.013-0.780), P = 0.03		0.63 (0.37-1.07, P < 0.001)
Major bleeding (%)	36/525 (6.9)	21/525 (4.0)	11/203 (4)	6/203 (6)	0/145 (0)	2/142 (1.4)	22/576 (3.8)	23/579 (4)
HR (CI) for major bleeding	1.77 (1.03-3.04)		1.83 (0.68-4.96)		Not estimable		0.82 (0.40-1.69, P = 0.6)
CRNMB (%)	76/525 (14.6)	58/525 (11.1)	25/203 (12.3)	7/203 (3.4)	9/145 (6.2)	7/142 (4.9)	52/576 (9)	35/579 (6.0)
HR (95%CI) for CRNMB	1.38 (0.98-1.94)		3.76 (1.63-8.69)		0.931 (0.43-2.02), P = 0.88		1.42 (0.88-2.30)

DVT: Deep vein thrombosis; PE: Pulmonary embolism; VTE: Venous thromboembolism; CI: Confidence interval; CRNMB: Clinically relevant non-major bleeding; HR: Hazard ratio; LMWH: Low-molecular-weight heparin.