"Thromboprophylaxis with Rivaroxaban in High-Risk Ambulatory Patients with Cancer". The New England Journal of Medicine. ClinicalTrials.gov number, NCT02555878.

Clinical Question

Does thromboprophylaxis with rivaroxaban in high-risk ambulatory patients with cancer reduce the incidence of venous thromboembolism or death due to venous thromboembolism?

Bottom Line

Thromboprophylaxis with rivaroxaban did not result in a significantly lower incidence of venous thromboembolism or death due to venous thromboembolism over a 180-day trial period when compared to placebo in high-risk ambulatory patients with cancer. However, during the intervention period, rivaroxaban led to a substantially lower incidence of such events, with a low incidence of major bleeding.

Major Points

Guidelines

Current guidelines do not routinely recommend thromboprophylaxis for ambulatory patients with cancer due to a lack of evidence and concerns about bleeding risks.

Design

Multicenter, double-blind, placebo-controlled, randomized trial with 841 patients randomized; 420 received rivaroxaban (10 mg/day) and 421 received placebo for up to 180 days.

Population

Included ambulatory patients with a solid tumor or lymphoma, Khorana score of ≥2, expected survival of more than 6 months, and starting a new systemic cancer therapy. Excluded those with primary brain tumors or known brain metastases, poor performance status, active bleeding, high bleeding risk.

Interventions

Patients receiving rivaroxaban (10 mg) or placebo daily for up to 180 days.

Outcomes

- Primary efficacy end point: Composite of objectively confirmed proximal deep-vein thrombosis, pulmonary embolism, symptomatic deep-vein thrombosis, and death from venous thromboembolism up to day 180.
- Primary safety end point: Major bleeding as defined by ISTH criteria.

Criticisms

Nearly 47% of patients discontinued the trial regimen prematurely, although discontinuation rates were similar across both groups.

Funding

Funded by Janssen and Bayer.

Further Reading