Table 2.
Efficacy and safety outcomes, according to treatment group
| Event | Dabigatran (no. of patients) | Warfarin (no. of patients) | Relative risk (95 % confidence interval) | P value |
|---|---|---|---|---|
| Intracardiac thrombus | 0 | 1 (8.3) | 1.1 (0.9–1.3) | 0.42 |
| Stroke or systemic embolism | 0 | 1 (8.3) | 1.1 (0.9–1.3) | 0.44 |
| Reversible ischemic neurological deficit | 1 (6.7) | 0 | 0.9 (0.8–1.0) | 0.55 |
| Bleedinga | 1 (6.7) | 2 (16.7) | 2.8 (0.2–35) | 0.41 |
| Hospitalization | 1 (6.7) | 1 (8.3) | 1.3 (0.7–22) | 0.70 |
| Death | 0 | 1 (8.3) | 1.1 (0.9–1.3) | 0.44 |
Values are number (%) unless indicated otherwise
HAS-BLED hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol, NA not applicable
aAccording criteria of Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis and HAS-BLED score