Table 3.
Data from prospective clinical trials assessing the efficacy and safety of direct oral anticoagulants in the prevention of thrombosis in cancer patients.
| Study | CASSINI | AVERT | ||
|---|---|---|---|---|
| Population | Adult patients starting chemotherapy assessed according to the Khorana scale ≥2 points | Adult patients starting chemotherapy assessed according to the Khorana scale ≥2 points | ||
| Period of observation (months) | 6 | 6 | ||
| Anticoagulant | rivaroxaban | placebo | apixaban | placebo |
| Group size | 420 | 421 | 291 | 283 |
| Mean age of patients (years) | 63 (23–87) | 62 (28–88) | 61.2 (SD = 12.4) | 61.7 (SD = 11.3) |
| Type of analysis | on-treatment analysis | intention-to-treat analysis | ||
| Occurrence of thrombosis (%) | 2.62 | 6.41 | 4.2 | 10.2 |
| HR 0.40, 95% CI 0.20–0.80 p = 0.007 |
HR 0.41, 95% CI 0.26–0.65 p < 0.001 |
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| Major bleeding (%) | 1.98 | 0.99 | 3.5 | 1.8 |
| HR 1.96, 95% CI 0.59–6.49 p = 0.265 |
HR 2.00, 95% CI 1.01–3.95 p = 0.046 |
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| CRNMB (%) | 2.72 | 1.98 | 7.3 | 5.5 |
| HR 1.34, 95% CI 0.54–3.32 p = 0.53 |
HR 1.28, 95% CI 0.89–1.84 p = NR |
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| Mortality (%) | 20.0 | 23.8 | 12.2 | 9.8 |
| HR 0.83, 95% CI 0.62–1.11 p = 0.213 |
HR 1.29, 95% CI 0.98–1.71 p = NR |
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CRNMB—clinically relevant non-major bleeding, NR—not reported.