Table 2.
Clinical trial characteristics for patients with atrial fibrillation and moderate renal impairment.
| Trial | Dabigatran4,30 |
Apixaban5,31 |
Edoxaban2,9,32 |
Rivaroxaban3,29 |
|
|---|---|---|---|---|---|
| RE-LY | ARISTOTLE | ENGAGE AF | ROCKET AF | ||
| Trial Design | Open label, blind to dabigatran dose | Double blind | Double blind | Double blind | |
| Length of trial, years | 2.0 | 1.8 | 2.8 | 1.9 | |
| Renal dose considerations | None; patients randomized to dabigatran dose | 50% dose reduction (2.5 mg BID) if 2/3 criteria met: age ⩾
80 weight ⩽ 60 kg creatinine ⩾ 133 μmol/l (1.5 mg/dl) |
50% dose reduction (30 mg OD) if CrCl 30–49 ml/min | 25% dose reduction (15 mg OD) if CrCl 30–49 ml/min | |
| Number of patients in phase III clinical trial | 18,113 | 18,201 | 21,105 | 14,264 | |
| Number of patients with CrCl <50 ml/min | 3374 | 3017 | 2740 * | 2950 $ | |
| Riva $ ‡ | Warfarin $ ‡ | ||||
| Age, years | 75.2 | 77.6 | 79 * | 79 | 79 |
| CHADS2 score, mean | Not reported | 2.6 | 3.1 * | 3.7 | 3.7 |
| Heart failure, % | 32.6 | 32.7 | 55 * | 66.0 | 65.3 |
| Hypertension, % | 85.6 | 84.9 | 92 * | 91.7 | 92.1 |
| Diabetes, % | 29.1 | 21.1 | 28 * | 31.8 | 33.3 |
| Previous stroke or TIA, % | 20.1 | 25.1 | 30 * | 50.1 | 49.1 |
*
Baseline characteristics reported for patients with moderate renal impairment receiving high dose edoxaban (60 mg daily or dose reduced to 30 mg daily) or warfarin; $CrCl <30–49 ml/min; ‡Baseline characteristics reported for rivaroxaban 15 mg and warfarin arms individually. AF, atrial fibrillation; BID, twice daily; CHADS2, score for estimating risk of stroke; CrCl, creatinine clearance; OD, once daily; TIA, transischemic attack.