. 2021 Aug 27;111(1):1–13. doi: 10.1007/s00392-021-01930-y

Table 3.

Outcome of HF populations in Non-Vitamin K oral anticoagulant approval trials for stroke prevention in atrial fibrillation

	RE-LY [21] dabigatran	ROCKET-AF [22] rivaroxaban	ARISTOTLE [23] apixaban	ENGAGE-AF [24] edoxaban
Rate for stroke/systemic embolism in HF vs non-HF, HR (95% CI)	1.75 vs 1.35%/year 1.08 (0.89–1.31)	1.99 vs 2.32/100 p-y 0.94 (0.78–1.13)	HF-PEF: 1.52 vs 1.37/100 p-y 1.11 (0.87–1.42)	NYHA I-II:1.62 vs 1.66%/year 1.19 (0.99–1.42)*
LVSD: 1.39 vs 1.37/100 p-y 1.01 (0.77–1.33)	NYHA III-IV:2.00 vs 1.66%/year 1.45 (1.12–1.88)*
Rate for primary safety event in HF vs non-HF, HR (95% CI)	3.42 vs 3.19%/year 1.03 (0.90–1.17)	14.12 vs 15.73/100 p-y 1.00 (0.92–1.08)	HF-PEF: 2.55 vs 2.50/100 p-y 1.02 (0.84–1.24)	NYHA I-II:2.96 vs 3.31%/year 1.24 (1.07–1.43)*
LVSD: 3.09 vs 2.50/100 p-y 1.23 (1.01–1.50)	NYHA III-IV:2.83 vs 3.31%/year 1.31 (1.05–1.65)*
Rate for stroke/systemic embolism vs VKA in patients with reduced LV-EF, HR (95% CI)	110 mg: 1.89 vs 1.61%/year 1.18 (0.55–2.53)	1.34 vs 1.87/100 p-y 0.72 (0.46–1.12)	0.99 vs 1.80/100 p-y^# 0.55 (0.34–0.91)	1.55 vs 1.76%/year 0.89 (0.63–1.24)
150 mg: 1.23 vs 1.61%/year 0.76 (0.33–1.76)
Rate for primary safety vs VKA in patients with reduced LV-EF, HR (95% CI)	110 mg: 3.91 vs 3.62%/year 1.09 (0.65–1.83) 150 mg:	15.34 vs 14.10/100 p-y 1.15 (0.96–1.36)	2.77 vs 3.41/100 p-y^# 0.81 (0.58–1.14)	2.87 vs 3.21%/year 0.91 (0.69–1.20)
2.70 vs 3.62%/year 0.75 (0.43–1.32)

RE-LY [21]
dabigatran

ROCKET-AF [22]
rivaroxaban

ARISTOTLE [23]
apixaban

ENGAGE-AF [24]
edoxaban

Rate for stroke/systemic embolism in HF vs non-HF, HR (95% CI)

1.75 vs 1.35%/year

1.08 (0.89–1.31)

1.99 vs 2.32/100 p-y

0.94 (0.78–1.13)

HF-PEF: 1.52 vs 1.37/100 p-y 1.11 (0.87–1.42)

NYHA I-II:1.62 vs 1.66%/year

1.19 (0.99–1.42)*

LVSD: 1.39 vs 1.37/100 p-y

1.01 (0.77–1.33)

NYHA III-IV:2.00 vs 1.66%/year

1.45 (1.12–1.88)*

Rate for primary safety event in HF vs non-HF, HR (95% CI)

3.42 vs 3.19%/year

1.03 (0.90–1.17)

14.12 vs 15.73/100 p-y

1.00 (0.92–1.08)

HF-PEF: 2.55 vs 2.50/100 p-y

1.02 (0.84–1.24)

NYHA I-II:2.96 vs 3.31%/year

1.24 (1.07–1.43)*

LVSD: 3.09 vs 2.50/100 p-y

1.23 (1.01–1.50)

NYHA III-IV:2.83 vs 3.31%/year

1.31 (1.05–1.65)*

Rate for stroke/systemic embolism vs VKA in patients with reduced LV-EF, HR (95% CI)

110 mg:

1.89 vs 1.61%/year

1.18 (0.55–2.53)

1.34 vs 1.87/100 p-y

0.72 (0.46–1.12)

0.99 vs 1.80/100 p-y^#

0.55 (0.34–0.91)

1.55 vs 1.76%/year

0.89 (0.63–1.24)

150 mg:

1.23 vs 1.61%/year

0.76 (0.33–1.76)

Rate for primary safety vs VKA in patients with reduced LV-EF, HR (95% CI)

110 mg:

3.91 vs 3.62%/year

1.09 (0.65–1.83)

150 mg:

15.34 vs 14.10/100 p-y

1.15 (0.96–1.36)

2.77 vs 3.41/100 p-y^#

0.81 (0.58–1.14)

2.87 vs 3.21%/year

0.91 (0.69–1.20)

2.70 vs 3.62%/year

0.75 (0.43–1.32)

HF, heart failure; HR, hazard ratio (*HRs in ENGAGE-AF had been adjusted for unbalanced co-variates by the original investigators [31];^#event rates and HRs for LV-EF subpopulation in ARISTOTLE are shown as published by the original investigators [30]); LV-EF, left-ventricular ejection fraction; p-y, patient-years; VKA, Vitamin K antagonist