Table 3.
Patient populations in completed trials of novel oral anticoagulants versus warfarin
|
RE-LY [41] |
ROCKET-AF [52] |
ARISTOTLE [49] |
|||||
|---|---|---|---|---|---|---|---|
|
(n = 18,113) |
(n = 14,264) |
(n = 18,201) |
|||||
| DABI 110 | DABI 150 | WARF | RIVA | WARF | APIX | WARF | |
| Patients enrolled, n |
6015 |
6076 |
6022 |
7131 |
7133 |
9120 |
9081 |
| Age, y (SD) or (range) |
71.4 (8.6) |
71.5 (8.8) |
71.6 (8.6) |
73 (65–78) |
73 (65–78) |
70 (63–76) |
70 (63–76) |
| Male patients, % |
64.3 |
63.2 |
63.3 |
60.3 |
60.3 |
64.5 |
65.0 |
| CHADS2 scorea, mean (SD) |
2.1 (1.1) |
2.2 (1.2) |
2.1 (1.1) |
3.5 (0.9) |
3.5 (1.0) |
2.1 (1.1) |
2.1 (1.1) |
| CHADS2 scorea ≥3, % |
32.7 |
32.6 |
32.1 |
87.0 |
86.9 |
30.2 |
30.2 |
| Prior stroke or TIA, % |
19.9 |
20.3 |
19.8 |
54.9 |
54.6 |
19.2 |
19.7 |
| Hypertension, % |
78.8 |
78.9 |
78.9 |
90.3 |
90.8 |
87.3 |
87.6 |
| Diabetes, % |
23.4 |
23.1 |
23.4 |
40.4 |
39.5 |
25.0 |
24.9 |
| Prior heart failure, % |
32.2 |
31.8 |
31.9 |
62.6 |
62.3 |
35.5 |
35.4 |
| Paroxysmal AF, % |
32.1 |
32.6 |
33.8 |
17.5 |
17.8 |
15.1 |
15.5 |
| Prior VKA use, % |
50.1 |
50.2 |
48.6 |
62.3 |
62.5 |
57.1 |
57.2 |
| Median duration of follow-up, y | 2.0b | 1.9b | 1.8b | ||||
aCHADS2 score is calculated by assigning 1 point each for a history of congestive heart failure, hypertension, age ≥75 years, or diabetes, and by assigning 2 points for a history of stroke or TIA [9].
bMedian duration of follow-up for entire study population.
Abbreviations: AF, Atrial fibrillation; APIX, Apixaban; ARISTOTLE, Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; DABI, Dabigatran; RE-LY, Randomized Evaluation of Long-Term Anticoagulation Therapy; RIVA, Rivaroxaban; ROCKET-AF, Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; SD, Standard deviation; TIA, Transient ischemic attack; VKA, Vitamin K antagonist; WARF, Warfarin.