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.