Atrial Fibrillation: A Review of Recent Studies with a Focus on Those from the Duke Clinical Research Institute

Table 3

Hazard ratios with 95% CI for subgroup analyses for novel agents versus warfarin.

	Stroke and systemic embolism	Major and clinically relevant nonmajor bleeding
Renal function	HR (95%CI)	HR (95%CI)
ARISTOTLE
GFR ≤50	0.79 (0.55–1.14)	0.50 (0.38–0.66)
GFR 50–80	0.74 (0.56–0.97)	0.77 (0.62–0.94)
GFR >80	0.88 (0.64–1.22)	0.80 (0.61–1.04)
RE-LY*
Dabigatran 150 mg BID
CrCl <50 ml/min	0.50 (0.25–0.80)	n/a
CrCl 50–79 ml/min	0.70 (0.48–0.90)	n/a
CrCl ≥80 ml/min	0.78 (0.40–1.25)	n/a
Dabigatran 110 mg BID
CrCl <50 ml/min	0.77 (0.50–1.20)	n/a
CrCl 50–79 ml/min	0.90 (0.75–1.26)	n/a
CrCl ≥80 ml/min	0.90 (0.60–1.55)	n/a
ROCKET-AF
CrCl 30–49 ml/min	0.84 (0.57–1.23)	0.98 (0.84–1.14)
CrCl >50 ml/min	0.78 (0.63–0.98)	1.04 (0.96–1.13)
Prior stroke/TIA
ARISTOTLE
Prior stroke/TIA	0.76 (0.56–1.03)	1.07 (0.09–2.04)
No prior stroke/TIA	0.22 (0.03–0.47)	0.93 (0.54–1.32)
RE-LY
Dabigatran 110 mg	RR 0.84 (0.58–1.2)	RR 0.66 (0.48–0.90)
Dabigatran 150 mg	RR 0.75 (0.52–1.08)	RR 1.01 (0.77–1.34)
ROCKET-AF
Prior stroke/TIA	0.94 (0.77–1.16)	0.96 (0.87–1.07)
No prior stroke/TIA	0.77 (0.58–1.01)	1.10 (0.99–1.21)
Prior warfarin use
ARISTOTLE
VKA-experienced	0.73 (0.57–0.95)	0.66 (0.55–0.80)
VKA-naïve	0.86 (0.67–1.11)	0.73 (0.59–0.91)
RE-LY		Major bleeding
Dabigatran 150 mg BID
VKA-experienced	RR 0.66 (0.48–0.89)	RR 0.40 (0.24–0.67)
VKA-naïve	RR 0.63 (0.46–0.87)	RR 0.46 (0.27–0.78)
Dabigatran 110 mg BID
VKA-experienced	RR 0.87 (0.66–1.15)	RR 0.32 (0.18–0.56)
VKA-naïve	RR 0.93 (0.70–1.24)	RR 0.27 (0.14–0.52)
ROCKET-AF
VKA-experienced	0.97 (0.78–1.19)	1.09 (0.99–1.19)
VKA-naïve	0.76 (0.59–0.98)	n/a
Elderly
ARISTOTLE		Major bleeding
Age ≥75 years	0.71 (0.53–0.95)	0.64 (0.52–0.79)
Age 65–<75	0.72 (0.54–0.96)	0.71 (0.56–0.89)
Age <65	1.16 (0.77–1.73)	0.78 (0.55–1.11)
RE-LY
Dabigatran 150 mg BID
Age ≥75 years	0.67 (0.49–0.90)	1.18 (0.98–1.42)
Age <75 years	0.63 (0.46–0.86)	0.70 (0.57–0.86)
Dabigatran 110 mg BID
Age ≥75 years	0.88 (0.66–1.17)	1.01 (0.83–1.23)
Age <75 years	0.93 (0.70–1.23)	0.62 (0.50–0.77)
ROCKET-AF		Major bleeding
Age ≥75 years	0.80 (0.63–1.02)	1.11 (0.92–1.34)
Age <75 years	0.95 (0.76–1.19)	0.96 (0.78–1.19)
Prior CAD
ARISTOTLE
Prior CAD	0.95 (0.71–1.27)	0.78 (0.62–0.99)
No prior CAD	0.70 (0.56–0.89)	0.64 (0.53–0.77)
RE-LY*		Major bleeding
Dabigatran 150 mg BID
Prior CAD/MI	0.75 (0.51–1.10)	0.95 (0.75–1.20)
No prior CAD/MI	0.57 (0.48–0.76)	0.90 (0.80–1.13)
Dabigatran 110 mg BID
Prior CAD/MI	0.78 (0.58–1.13)	0.88 (0.75–1.10)
No prior CAD/MI	0.90 (0.75–1.20)	0.76 (0.63–0.90)
ROCKET-AF
Prior MI	0.92 (0.63–1.34)	1.21 (1.02–1.43)
No prior MI	0.87 (0.73–1.04)	n/a

*HR were visually estimated from primary publication.