Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM‐Line): A two‐center open‐label pilot randomized controlled trial

Abstract

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Venous thromboembolism associated with central venous catheters in patients with cancer: From pathophysiology to thromboprophylaxis, areas for future studies

“…54 Recently, an open blinded end trial compared standard care and a primary prophylaxis with rivaroxaban 10 mg daily for 3 months. 55 Thrombotic events occurred in three patients in the rivaroxaban group (5.8% n = 52) compared with five patients in the control group (9.4% n = 53) without an excess of bleeding. 56 In a curative setting, anticoagulant treatment of pediatric central venous catheter-related venous thromboembolism has been specifically evaluated in the EINSTEIN-Jr study.…”

“…57 Children with catheter-related thrombosis were administered rivaroxaban (n = 96) or standard anticoagulants (n = 30). 55 Complete or partial vein recanalization occurred in 57 (55%) and 38 (37%) of 103 evaluable children, three children experienced clinically relevant nonmajor bleeding (2.4%; 95% CI, 0.7%-6.5%), all in the rivaroxaban arm. There were no major bleeds in this study, but DOAC hemorrhagic complications are an issue of concern in cancer patients.…”

“…In a curative setting, anticoagulant treatment of pediatric central venous catheter–related venous thromboembolism has been specifically evaluated in the EINSTEIN‐Jr study 57 . Children with catheter‐related thrombosis were administered rivaroxaban ( n = 96) or standard anticoagulants ( n = 30) 55 . Complete or partial vein recanalization occurred in 57 (55%) and 38 (37%) of 103 evaluable children, three children experienced clinically relevant nonmajor bleeding (2.4%; 95% CI, 0.7%–6.5%), all in the rivaroxaban arm.…”

“…However, this trial had an important limitation which is the lack of randomization because treatment was decided by the physicians 54 . Recently, an open blinded end trial compared standard care and a primary prophylaxis with rivaroxaban 10 mg daily for 3 months 55 . Thrombotic events occurred in three patients in the rivaroxaban group (5.8% n = 52) compared with five patients in the control group (9.4% n = 53) without an excess of bleeding 56 .…”

2022 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer, including patients with COVID-19

“…The 2022 ITAC guidelines against routine primary prophylaxis of central venous catheter-related VTE have remained unchanged from the 2016 publication. 4 In a pilot randomised controlled trial 71 of 105 patients with cancer and with new central venous catheters receiving rivaroxaban 10 mg daily, or no intervention, VTE occurred in 5·8% of patients in the rivaroxaban group and 9·4% patients in the control group (HR 0·58; 95% CI 0·14–2·5). One patient (1·9%) on rivaroxaban had major bleeding.…”