Table 4. Results of phase 3 trials of... | American Society of Hematology

Table 4.

Results of phase 3 trials of DOACs vs conventional therapy in the subgroup of patients with acute pulmonary embolism

Trial	Reference	Design	DOAC regimen	Comparator	Duration, mo	PE patients	Efficacy outcome	Safety outcome
RE-COVER I plus II 2014	43	DB	Enoxa followed by dabigatran 150 mg twice daily	Enoxaparin/ warfarin	6	1602	Recurrent VTE or fatal PE	Major/clinically relevant nonmajor bleeding*
							2.3% enoxa/dabigatran,	5.3% dabigatran,
							2.6% enoxa/warfarin	8.5% warfarin
Einstein-PE 2012	41	Open	Rivaroxaban 15 mg twice daily for 3 wk, then 20 mg once daily	Enoxaparin/ VKA	3, 6, or 12	4832	Recurrent VTE	Major/clinically relevant nonmajor bleeding
							2.1% rivaroxaban,	10.3% rivaroxaban,
							1.8% enoxa/VKA	11.4% enoxa/VKA
AMPLIFY 2013	44	DB	Apixaban 10 mg twice daily for 7 d, then 5 mg twice daily	Enoxaparin/ warfarin	6	1836	Recurrent VTE	Major bleeding
							2.3% apixaban,	0.4% apixaban,
							2.6% enoxa/VKA	2.8% enoxa/warfarin
Hokusai-VTE Investigators 2013	45	DB	LMWH followed by edoxaban 60 mg once daily or 30 mg once daily	UFH or LMWH/ warfarin	≤12	3319	Recurrent VTE	Major/clinically relevant nonmajor bleeding
							3.2% enoxa/edoxaban,	8.5% enoxa/edoxaban,
							3.5% enoxa/warfarin	10.3% enoxa/warfarin

Trial	Reference	Design	DOAC regimen	Comparator	Duration, mo	PE patients	Efficacy outcome	Safety outcome
RE-COVER I plus II 2014	43	DB	Enoxa followed by dabigatran 150 mg twice daily	Enoxaparin/ warfarin	6	1602	Recurrent VTE or fatal PE	Major/clinically relevant nonmajor bleeding*
							2.3% enoxa/dabigatran,	5.3% dabigatran,
							2.6% enoxa/warfarin	8.5% warfarin
Einstein-PE 2012	41	Open	Rivaroxaban 15 mg twice daily for 3 wk, then 20 mg once daily	Enoxaparin/ VKA	3, 6, or 12	4832	Recurrent VTE	Major/clinically relevant nonmajor bleeding
							2.1% rivaroxaban,	10.3% rivaroxaban,
							1.8% enoxa/VKA	11.4% enoxa/VKA
AMPLIFY 2013	44	DB	Apixaban 10 mg twice daily for 7 d, then 5 mg twice daily	Enoxaparin/ warfarin	6	1836	Recurrent VTE	Major bleeding
							2.3% apixaban,	0.4% apixaban,
							2.6% enoxa/VKA	2.8% enoxa/warfarin
Hokusai-VTE Investigators 2013	45	DB	LMWH followed by edoxaban 60 mg once daily or 30 mg once daily	UFH or LMWH/ warfarin	≤12	3319	Recurrent VTE	Major/clinically relevant nonmajor bleeding
							3.2% enoxa/edoxaban,	8.5% enoxa/edoxaban,
							3.5% enoxa/warfarin	10.3% enoxa/warfarin

DB, double-blind; DVT, deep vein thrombosis; LMWH, low-molecular-weight heparin; UFH, unfractionated heparin; VKA, vitamin K antagonist; VTE, venous thromboembolism.

Data from the overall RECOVER studies’ populations (pulmonary embolism or deep vein thrombosis) as separate data are not available.

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