Real-world data emulating randomized controlled trials of non-vitamin K antagonist oral anticoagulants in patients with venous thromboembolism

Table 1 Baseline characteristics of RCTs and the corresponding emulation of RWE studies

Variables	AMPLIFY		RE-COVER II		Hokusai-VTE		EINSTEIN-DVT		EINSTEIN-PE
Variables	Apixaban	Warfarin	Dabigatran	Warfarin	Edoxaban	Warfarin	Rivaroxaban	Warfarin	Rivaroxaban	Warfarin
Age, mean ± SD, years
RCT	57.2 ± 16.0	56.7 ± 16.0	54.7 ± 16.2	55.1 ± 16.3	55.7 ± 16.3	55.9 ± 16.2	55.8 ± 16.4	56.4 ± 16.3	57.9 ± 7.3	57.5 ± 7.2
RWE	68.9 ± 17.0	68.9 ± 16.4	68.0 ± 16.3	68.0 ± 16.3	68.8 ± 16.1	68.8 ± 16.1	63.3 ± 16.7	62.9 ± 17.1	69.0 ± 15.5	69.0 ± 15.2
Male, %
RCT	58.3	59.1	61.0	60.2	57.3	57.2	57.4	56.3	54.1	51.7
RWE	42.4	40.8	41.0	40.9	39.9	39.5	44.1	45.0	40.5	41.7
DVT only, %
RCT	65.0	65.9	68.5	67.8	59.9	59.5	98.7	98.8	0	0
RWE	33.9	34.0	29.5	30.6	34.3	34.4	100	100	0	0
PE with or without DVT, %
RCT	34.6	33.5	31.4	32.2	40.1	40.5	0.69	0.64	100	100
RWE	66.1	66.0	70.5	69.4	65.7	65.6	0	0	100	100
Previous VTE, %
RCT	17.2	15.1	19.3	15.8	19.0	17.9	19.4	19.2	18.8	20.3
RWE	18.0	17.9	18.8	18.2	19.6	18.3	24.7	24.2	14.8	15.4
Active cancer, %
RCT	2.5	2.8	3.9	3.9	9.2	9.5	6.8	5.2	4.7	4.5
RWE	12.2	11.0	4.2	4.4	10.6	10.4	11.6	11.0	15.0	15.4
Asian fraction, %^a
RCT	8.4	8.4	20.9^a	20.9^a	21.0	20.9	12.2	12.3	6.0	5.9

Abbreviations: RCT randomized controlled trial, RWE real-world evidence, SD standard deviation, DVT deep vein thrombosis, PE pulmonary embolism, VTE venous thromboembolism
^aAlthough information on race/ethnicity is unavailable in the HIRA database, the Asian fraction would be estimated to be approximately 99.9% (only 60,000–70,000 patients are non-Asian among the whole population in the Korean national health insurance system), the values of RE-COVER II were not reported separately in each intervention group

ISSN: 1741-7015