Table 1:
Study and Baseline Population Characteristics of Included Studies
| Study, Yeara | Intervention, Dosage (n) | Comparator, INR (n) | Follow-Up (years) | Patient Inclusion | Total no. of patients | Age (years)b | Male (%) | CHADS Score (mean) | Prior MI (%) |
|---|---|---|---|---|---|---|---|---|---|
| RE-LY, 200915 | Dabigatran, 110 mg bid (n = 6,015) Dabigatran, 150 mg bid (n = 6,076) |
Warfarin, INR 2–3 (n = 6,022) | 2 | 12/2005–3/2009 | 18,113 | 71.5 ± 8.5 | 63.5 | 2.1, 2.2 | 17 |
| ARISTOTLE, 201116 | Apixaban, 2.5 mg bid (n = 9,120) | Warfarin, INR 2–3 (n = 9,081) | 1.8 | 12/2006–4/2010 | 18,201 | 70 | 65 | 2.1 ± 1.1 | 14 |
| ROCKET AF, 201117 | Apixaban, 5 mg bid (n = 9,120) | Warfarin, INR 2–3 (n = 7,090) | 1.9 | 12/2006–5/2010 | 14,264 | (63–76) | 60 | 3.5 ± 1 | 17 |
| J ROCKET AF, 201218 | Rivaroxaban, 20 mg (n = 7,081) | Warfarin, INR 2–3 in patients < 70 years, INR 1.6–2.6 in patients ≥ 70 years (n = 640) | 6/2007–1/2010 | 1,278 | 73 | 80.6 | 3.25 | 8 | |
| ENGAGE AF, 201319 | Rivaroxaban, 15 mg (n = 640) | Warfarin, INR 2–3 (n = 7,036) | 2.8 | 8/2008–11/2010 | 21,105 | (65–78) | 62 | 2.8 ± 1 | – |
| PREVAIL, 201420 | Edoxaban, 30 mg (n = 7,034) | Warfarin, INR 2–3 (n = 138) | 2.1 | 8/2010–1/2013 | 407 | 71.1 | 70 | 2.6 ± 1 | – |
| PROTECT AF, 201421 | Edoxaban, 60 mg (n = 7,035) | Warfarin, INR 2–3 (n = 244) | 4 | 2/2005–3/2009 | 707 | 72 | 70 | 2.2 | – |
Abbreviations: INR, international normalized ratio; FU, follow-up; CHADS, Congestive heart failure, Hypertension, Age, Diabetes, Stroke; MI, myocardial Infarction
a
All studies were double-blinded randomized controlled trials except for PREVAIL and PROTECT AF, which were randomized but not double-blinded.
b
Age is expressed as mean ± standard deviation or mean (interquartile range).