Results of a recent pilot study indicated potential feasibility for a large randomized controlled trial to evaluate thrombotic complications in patients with cancer who have a newly inserted central venous catheter. Additionally, such complications appeared common in the evaluated patient population. The study results were published in the journal Research and Practice in Thrombosis and Haemostasis.
The pilot study was the phase 3 prospective, open-label Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Lines trial (TRIM-Line; ClinicalTrials.gov Identifier: NCT03506815), which was conducted at 2 centers in Canada. In this study, patients were randomly assigned 1:1 to either receive rivaroxaban treatment (10 mg/day) or observation for 90 days. Eligible patients had active cancer and a newly inserted central venous catheter.
The study had a primary feasibility outcome of number of participants recruited per month. Thrombotic complications, major venous thromboembolism (VTE), and major bleeding episodes were secondary outcomes.
Over a period of 11 months, the study enrolled 105 patients. This translated into average enrollment rates of 7.5 patients per month at 1 participating center and 2.0 patients per month at the other center. The rivaroxaban treatment group included 52 patients, and the observation group consisted of 53 patients. The median study follow-up was 90 days across each group. No patients were reported lost to follow-up.
Of cancer types, breast and colorectal cancers were most common among evaluated patients. Most patients (78.1%) had a peripherally inserted central catheter (PICC line), while 22% had an infusion port. In the rivaroxaban group, rivaroxaban was given for a median duration of 88 days, and the rate of compliance in this group was 96.7%.
There were thrombotic complications in 3 patients (5.8%) in the rivaroxaban group and in 5 patients (9.4%) in the observation group, for a hazard ratio (HR) of 0.58 (95% CI, 0.14-2.5). The rivaroxaban group had 2 patients (3.9%) with major VTE events reported, compared with 3 patients (5.7%) in the observation group (HR, 0.66; 95% CI, 0.11-3.9). A major bleeding event was reported in a single patient (1.9%) in the rivaroxaban group.
The study investigators determined that thrombotic complications seemed common in this patient population with newly inserted central venous catheters. They also determined that the pilot study confirmed an RCT would be feasible for addressing this topic.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Ikesaka R, Siegal D, Mallick R, et al. Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM-Line): a two-center open-label pilot randomized controlled trial. Res Pract Thromb Haemost. 2021;5(4):e12517. doi:10.1002/rth2.12517