"Thromboprophylaxis with Rivaroxaban in High-Risk Ambulatory Patients with Cancer". The New England Journal of Medicine. ClinicalTrials.gov number, NCT02555878.
Links to original sources: Wiki Journal Post Full Journal Article
Does thromboprophylaxis with rivaroxaban in high-risk ambulatory patients with cancer reduce the incidence of venous thromboembolism or death due to venous thromboembolism?
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.
Although venous thromboembolism is a common complication in patients with cancer, routine thromboprophylaxis in the outpatient setting is not widely recommended. The CASSINI trial investigated the use of rivaroxaban for thromboprophylaxis in ambulatory patients with cancer who were at high risk for venous thromboembolism, as designated by a Khorana score of ≥2. While no significant difference was found over the full 180-day period, a significant benefit was observed during the period when patients were actively taking rivaroxaban.
Current guidelines do not routinely recommend thromboprophylaxis for ambulatory patients with cancer due to a lack of evidence and concerns about bleeding risks.
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.
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.
Patients receiving rivaroxaban (10 mg) or placebo daily for up to 180 days.
- 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.
Nearly 47% of patients discontinued the trial regimen prematurely, although discontinuation rates were similar across both groups.
Funded by Janssen and Bayer.
The full text of the CASSINI trial published in The New England Journal of Medicine, ClinicalTrials.gov number, NCT02555878.