Key result
Extended-phase rivaroxaban yields comparable recurrent VTE rates in patients with and without cancer.
Why the study?
Extended-phase anticoagulation with direct oral factor Xa inhibitors is suggested in patients with cancer-associated venous thromboembolism, but real-world evaluation of rivaroxaban is needed.
Does rivaroxaban as extended-phase anticoagulation safely prevent recurrent VTE in patients with cancer-associated venous thromboembolism compared to those without?
Cohort (n=604)
Does rivaroxaban as extended-phase anticoagulation safely prevent recurrent VTE in patients with cancer-associated venous thromboembolism compared to those without?
Odds Ratio: 1.2 (95% CI 0.5–2.9)
Absolute Event Rate: 9.3% vs 8.1%
p-value: p=0.6
Rivaroxaban appears effective and safe for extended-phase anticoagulation in patients with cancer-associated VTE, showing similar rates of recurrence and bleeding compared to non-cancer patients.
Supports extended rivaroxaban consideration in cancer VTE; observational data leaves open need for randomized confirmation.
Extended-phase anticoagulation with direct oral Xa inhibitors (OAXI) is suggested in patients with cancer-associated venous thromboembolism (CAT). We report on patients enrolled in the MAC (Monitoring AntiCoagulants) Project, given rivaroxaban as extended-phase anticoagulation after CAT. The primary efficacy outcome was the incidence of symptomatic recurrent VTE; the primary safety outcomes were incidence of major and non-major clinically relevant bleeding, adverse events, and all-cause mortality. The mean patients’ follow-up was 19 months (SD 16); 64/604 (11%) had CAT. Recurrent VTE occurred in 9.3% and in 8.1% of patients with and without CAT (OR 1.2, 95% CI 0.5 to 2.9; p = 0.6). Major bleeding occurred in 4.7% and in 2.6%, respectively (OR = 1.8, 95% CI 0.5 to 6.6, p = 0.4), and non-major clinically-relevant bleeding in 4.7% and in 4.1% (OR = 1.2, 95% CI 0.3 to 3.9, p = 0.7). The relative figures for fatal haemorrhage and all-cause death were 1.6% versus 0%, and 1.6% versus 0.4%. Rivaroxaban appears to be effective and safe as extended-phase anticoagulation in patients with CAT. The mean treatment period was 3-times the standard 6-month course.
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Bernardi et al. (2022) conducted a cohort in Cancer-associated venous thromboembolism (CAT) (n=604). Rivaroxaban vs. Patients without cancer-associated VTE was evaluated on incidence of symptomatic recurrent VTE (OR 1.2, 95% CI 0.5 to 2.9, p=0.6). Extended-phase rivaroxaban in patients with cancer-associated VTE resulted in a 9.3% rate of recurrent VTE, comparable to 8.1% in patients without cancer (OR 1.2; 95% CI 0.5-2.9; p=0.6).
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