Table 2.
Bleeding and clinical events of atrial fibrillation patients receiving rivaroxaban with and without anti-arrhythmic drugs in the propensity score-matched analysis.
| Rivaroxaban alone (n = 738) |
Concomitant-AAD (n = 739) |
P | |||
|---|---|---|---|---|---|
| Follow-up time (months), mean (SD) | 31.4 | (10.8) | 31.9 | (10.7) | 0.413 |
| Safety endpoint, no. (%) | 86 | (11.6) | 100 | (13.5) | 0.308 |
| Bleeding needs transfusion ≥ 2U or Hb drop ≥ 2 g/dL, no. (%) | 21 | (2.8) | 23 | (3.1) | 0.879 |
| GI bleeding, no. (%) | 31 | (4.2) | 31 | (4.2) | 1.000 |
| Effectiveness endpoint, no. (%) | 29 | (3.9) | 25 | (3.4) | 0.583 |
| New ischemic stroke, no. (%) | 9 | (1.2) | 13 | (1.8) | 0.520 |
| New hemorrhagic stroke, no. (%) | 2 | (0.3) | 6 | (0.8) | 0.288 |
| New stroke (new ischemic stroke and hemorrhagic stroke), no. (%) | 10 | (1.4) | 18 | (2.4) | 0.181 |
| Systemic thromboembolism, no. (%) | 20 | (2.7) | 6 | (0.8) | 0.005 |
| MACE, no. (%) | 50 | (6.8) | 47 | (6.4) | 0.754 |
| Non-fatal MI, no. (%) | 7 | (0.9) | 12 | (1.6) | 0.356 |
| HF readmission, no. (%) | 62 | (8.4) | 98 | (13.3) | 0.003 |
| With AF relapse, no. (%) | 15 | (2.0) | 31 | (4.1) | 0.024 |
| Without AF relapse, no. (%) | 47 | (6.4) | 67 | (9.2) | 0.064 |
| ARF, no. (%) | 7 | (0.9) | 5 | (0.7) | 0.579 |
| CV death, no. (%) | 19 | (2.6) | 12 | (1.6) | 0.210 |
| All cause death, no. (%) | 74 | (10.0) | 51 | (6.9) | 0.032 |
Effectiveness endpoint: new ischemic stroke, ICH, or embolism. Safety endpoint (by ISTH definition): Hb fall ≥ 2 g/dL or transfusion ≥ 2 U PRBC, critical site bleeding, or fatal bleeding.
AF, Atrial fibrillation; MACE, CV death; MI, new ischemic stroke, embolism, or ICH.