Table 4.
Study Characteristics and Results for the CASSINI and AVERT Trials for VTE Prophylaxis
| Study | CASSINI | AVERT |
|---|---|---|
| Patients | 841 patients with cancer and a KS of ≥2 Patients with primary or metastatic brain cancer and those at risk for bleeding were excluded |
574 patients with cancer and a KS of ≥2 Nonmelanoma skin cancers, acute leukemia, myeloproliferative neoplasms, and those at high risk for bleeding were excluded |
| Type of cancers | Solid tumors and lymphomas | Solid and primary brain tumors, lymphomas, and myeloma |
| Baseline screening | Yes | No |
| Duration, days | 180 | 180 |
| Treatment Arms | Rivaroxaban 10 mg Daily |
Placebo | Apixaban 2.5 mg Twice Daily |
Placebo |
|---|---|---|---|---|
| VTE, % | 6.0 | 8.8 | 4.2 | 10.2 |
| HR (95% CI); p value | 0.66 (0.40–1.09); p = 0.10 | 0.41 (0.26–0.65); p < 0.001 | ||
| Major bleeding, % | 2.0 | 1.0 | 3.5 | 1.8 |
| HR (95% CI); p value | 1.96 (0.59–6.49); p = 0.26 | 2.00 (1.01–3.95); p = 0.046 | ||
| CRNMB, % | 2.7 | 2.0 | 7.3 | 5.5 |
| HR (95% CI); p value | 1.34 (0.54–3.32); p = 0.53 | 1.28 (0.89–1.84); p = NR | ||
| Mortality, % | 20.0 | 23.3 | 12.2 | 9.8 |
| HR (95% CI); p value | 0.83 (0.62–1.11); p = 0.21 | 1.29 (0.98–1.71); p = NR | ||
| Mortality benefit | Potential | No | ||
AVERT = Apixaban to Prevent Venous Thromboembolism in Patients with Cancer; CI = confidence interval; CRNMB = clinically relevant nonmajor bleeding; HR = hazard ratio; KS = Khorana score; NR = not reported; VTE = venous thromboembolism.