Primary Thromboprophylaxis in Patients with Malignancy and Central Venous Catheters: TRIM-Line Randomized Controlled Trial—Design and Rationale
Tzu-Fei Wang, Rick Ikesaka, Isabelle Mahé, Danny Hill, Catherine Sperlich, Vicky Tagalakis, Sudeep Shivakumar, Blair Leonard, Andrea Cervi, Philip G. Kuruvilla, Fréderic Larose, Davide Matino, Steffan Frosi Stella, Chantal Séguin, Abdulrahman Al Raizah, Grégoire Le Gal, Deborah M. Siegal, Aurélien Delluc, Ranjeeta Mallick, Alejandro Lazo-Langner, Cynthia Wu, Dennis Christopher, Marcello Di Nisio, Walter Ageno, Bashour Yazji, Marc CarrierPatients with cancer have an increased risk of venous thromboembolism (VTE). This risk is further elevated in those with a central venous catheter (CVC). Previous studies have shown that prophylactic doses of direct oral anticoagulants (DOACs) reduce the risk of VTE in ambulatory cancer patients starting chemotherapy, which has led to recommendations from international clinical guidelines to use DOACs as primary thromboprophylaxis in this population. Primary thromboprophylaxis after CVC insertion is not recommended due to a lack of definitive evidence. As such, the TRIM-Line trial randomized 1,828 patients with active cancer and a newly inserted CVC to rivaroxaban 10 mg daily versus placebo. The primary efficacy outcome was the first objectively confirmed symptomatic or incidental major VTE (proximal upper or lower extremity deep vein thrombosis and/or pulmonary embolism) within 90 days of randomization. The primary safety outcome was major bleeding, as defined by the International Society on Thrombosis and Haemostasis criteria, within 90 days. The key secondary outcomes included clinically relevant non-major bleeding, arterial thrombosis, and overall mortality. The study provides high-quality evidence to address a key knowledge gap regarding the benefits and risks of thromboprophylaxis in patients with active cancer and an indwelling CVC (NCT05029063).