Review Article
Management of Venous Thromboembolism in Patients with Advanced Gastrointestinal Cancers: What Is the Role of Novel Oral Anticoagulants?
Table 4
Summary of completed phase III trials of novel oral anticoagulants.
| Study | Agent investigated | Control | Setting | Treatment duration | N/N with cancer-related VTE | Primary outcome | HR (95% CI) | value | VTE recurrence | Clinically relevant bleeding |
| RE-COVER | Dabigatran etexilate* | Warfarin* | Acute symptomatic VTE | 6 months | 2539/121 | Non-inferiority | 1.1 (0.65, 1.84) | <0.001 | E: 2.4% C: 2.1% | E: 5.6% C: 8.8% | RE-SONATEa | Dabigatran etexilate | Placebo | Treated VTE | 6 months | 1343/NA** | Superiority | 0.08 (0.02, 0.25) | <0.0001 | E: 0.4% C: 5.6% | E: 5.3% C: 1.8% | RE-MEDYa | Dabigatran etexilate | Warfarin | Treated VTE | 6–36 months | 2856/NA | Non-inferiority | 1.44 (0.78, 2.64) | 0.03 | E: 1.8% C: 1.3% | NA** NA** | EINSTEIN-DVT | Rivaroxaban | LMWH/VKA | Acute DVT | 3, 6 or 12 months | 3449/207 | Non-inferiority | 0.68 (0.44, 1.04) | <0.001 | E: 2.1% C: 3% | E: 8.1% C: 8.1% | EINSTEIN-Extension | Rivaroxaban | Placebo | Treated VTE | 6 or 12 months | 1196/54 | Superiority | 0.18 (0.09, 0.39) | <0.001 | E: 1.3% C: 7.1% | E: 6% C: 1.2% |
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*Following initial treatment with intravenous anticoagulation.
**Not available.
*Abstract only.
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