Table 3.
Randomized Controlled Trials Evaluating the Use of the Direct Oral Anticoagulants for the Prevention of Cancer-Associated Thrombosis in Ambulatory Patients
| Study (Year) | Inclusion Criteria | Patients, N | Anticoagulant Treatment | Treatment Duration | Outcomes | |||
|---|---|---|---|---|---|---|---|---|
| VTE, N (%), HR* (95%CI) | MB, N (%), HR* (95%CI) | CRNMB, N (%), HR* (95%CI) | Mortality, N (%), HR* (95%CI) | |||||
| AVERT 2019,77 | Ambulatory cancer patients at intermediate-to-high risk for VTE (Khorana score, ≥2), and initiating chemotherapy | 275 | Placebo | 5.1 months (median) | 28 (10.2%) | 5 (1.8%) | 15 (5.5%) | 27 (9.8%) |
| 288 | Apixaban 2.5 mg BID | 5.1 months (median) | 12 (4.2%), 0.41 (0.26–0.65) | 10 (3.5%), 2.00 (1.01–3.95) | 21 (7.3%), 1.28 (0.89–1.84) | 35 (12.2%), 1.29 (0.98–1.71) | ||
| CASSINI 2019,81 | High-risk ambulatory cancer patients (Khorana score ≥2), starting a new systemic cancer therapy | 421 | Placebo | 4.3 months (mean) | 37 (8.8%) | 4 (1.0%) | 8 (2.0%) | NR |
| 420 | Rivaroxaban 10 mg OD | 4.3 months (mean) | 25 (6.0%), 0.66 (0.40–1.09) | 8 (2.0%), 1.96 (0.59–6.49) | 11 (2.7%), 1.34 (0.54–3.32) | NR | ||
Note: * HR are for DOAC vs placebo.
Abbreviations: BID, twice daily; CI, confidence interval; CRNMB, clinically relevant non major bleeding; HR, hazard ratio; MB, major bleeding; NR, not reported; OD, once daily; VTE, venous thromboembolism.