AVERROES: Apixaban yields significant reductions in stroke, no increased bleeding
Patients with atrial fibrillation unable to take warfarin who are treated with apixaban (Pfizer/Bristol-Myers Squibb), an investigational oral factor Xa inhibitor, had a significantly lower risk of stroke and systemic embolic events compared with patients treated with aspirin.
Importantly, the benefits of apixaban did not come at a cost of increased bleeding, with no observed increases in the risk of major bleeding, minor bleeding, or intracranial hemorrhage, among other end points, in those treated with apixaban.
| Outcomes | Apixaban (n=2809) | Aspirin (n=2791) | Relative risk (95%CI) |
| Stroke or systemic embolic event | 1.6 | 3.6 | 0.46 (0.33-0.64) |
| Stroke, embolic event, MI, or vascular death | 4.1 | 6.2 | 0.66 (0.53-0.83) |
| MI | 0.7 | 0.8 | 0.85 (0.48-1.50) |
| Vascular death | 2.5 | 2.9 | 0.86 (0.64-1.16) |
| Cardiovascular hospitalizations | 11.8 | 14.9 | 0.79 (0.68-0.91) |
| Total death | 3.4 | 4.4 | 0.79 (0.62-1.02) |
AVERROES: Bleeding events
| Outcomes | Apixaban (n=2809) | Aspirin (n=2791) | Relative risk (95% CI) |
| Major bleeding | 1.4 | 1.2 | 1.14 (0.74-1.75) |
| Clinical relevant nonmajor bleeding | 3.0 | 2.6 | 1.18 (0.88-1.58) |
| Minor bleeding | 5.2 | 4.1 | 1.27 (1.01-1.61) |
| Fatal bleeding | 0.1 | 0.1 | 0.84 (0.26-2.75) |
| Intracranial | 0.4 | 0.3 | 1.09 (0.50-2.39) |
Comments