Adjudicated efficacy and safety outcomes
| Outcome, n . | “As treated” analysis . | ITT analysis . | ||||||
|---|---|---|---|---|---|---|---|---|
| Rivaroxaban (n = 59) . | Warfarin (n = 61) . | HR (95% CI) . | P . | Rivaroxaban (n = 59) . | Warfarin (n = 61) . | HR (95% CI) . | P . | |
| Thromboembolic events, major bleeding, and vascular death | 11 (19) | 2 (3) | 6.7 (1.5-30.5) | .01 | 13 (22) | 2 (3) | 7.4 (1.7-32.9) | .008 |
| Arterial thrombosis | 7 (12) | 0 | — | — | 7 (12) | 0 | — | — |
| Ischemic stroke | 4 (7) | 0 | 4 (7) | 0 | ||||
| Myocardial infarction | 3 (5) | 0 | 3 (5) | 0 | ||||
| Venous thromboembolism | 0 | 0 | 1 (2) | 0 | ||||
| Major bleeding | 4 (7) | 2 (3) | 2.5 (0.5-13.6) | .3 | 4 (7) | 2 (3) | 2.3 (0.4-12.5) | .3 |
| Death | 0 | 0 | — | — | 1 (2) | 0 | — | — |
| Outcome, n . | “As treated” analysis . | ITT analysis . | ||||||
|---|---|---|---|---|---|---|---|---|
| Rivaroxaban (n = 59) . | Warfarin (n = 61) . | HR (95% CI) . | P . | Rivaroxaban (n = 59) . | Warfarin (n = 61) . | HR (95% CI) . | P . | |
| Thromboembolic events, major bleeding, and vascular death | 11 (19) | 2 (3) | 6.7 (1.5-30.5) | .01 | 13 (22) | 2 (3) | 7.4 (1.7-32.9) | .008 |
| Arterial thrombosis | 7 (12) | 0 | — | — | 7 (12) | 0 | — | — |
| Ischemic stroke | 4 (7) | 0 | 4 (7) | 0 | ||||
| Myocardial infarction | 3 (5) | 0 | 3 (5) | 0 | ||||
| Venous thromboembolism | 0 | 0 | 1 (2) | 0 | ||||
| Major bleeding | 4 (7) | 2 (3) | 2.5 (0.5-13.6) | .3 | 4 (7) | 2 (3) | 2.3 (0.4-12.5) | .3 |
| Death | 0 | 0 | — | — | 1 (2) | 0 | — | — |
Numbers in parentheses denote percentage with respect to total.
—, statistical analysis not applicable.