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. 2019 Mar;8(3):1044-1053.
doi: 10.1002/cam4.1997. Epub 2019 Feb 14.

Risk of recurrence and bleeding in patients with cancer-associated venous thromboembolism treated with rivaroxaban: A nationwide cohort study

Mette Søgaard  1   2 , Peter Brønnum Nielsen  1   2 , Flemming Skjøth  2   3 , Jette Nordstrøm Kjaeldgaard  1   2 , Torben Bjerregaard Larsen  1   2
Affiliations

Risk of recurrence and bleeding in patients with cancer-associated venous thromboembolism treated with rivaroxaban: A nationwide cohort study

Mette Søgaard et al. Cancer Med. 2019 Mar.

Abstract

Background: Rivaroxaban could be an attractive alternative to low molecular weight heparin for the treatment of cancer-associated venous thromboembolism (VTE) but the safety and effectiveness remain unclear. We examined risk of recurrent VTE and major bleeding associated with rivaroxaban treatment of cancer-associated VTE.

Methods: Through linkage of nationwide Danish registries, we identified all adults with cancer-associated VTE initiating treatment with rivaroxaban, 2012-2017. We estimated rates and absolute risk of the primary outcome of recurrent VTE and major bleeding; all-cause mortality was studied as a secondary outcome.

Results: We identified 8901 patients with cancer-associated VTE of whom 476 (5.3%) redeemed a prescription for rivaroxaban within 30 days of VTE diagnosis (mean age 71.5 years, 41% females, 57% with pulmonary embolism). Median time from cancer diagnosis to rivaroxaban prescription was 31 days (interquartile range 12-73 days). Most frequent cancers were gastrointestinal (26.1%), genitourinary (23.3%), and hematological cancer (12.6%). Few had distant metastases (7.1%). At 6 months, recurrent VTE occurred in 6.1% (15.1 events per 100 person-years) with the highest absolute risks for genitourinary cancer (8.1%), gastrointestinal cancer (7.3%), and breast cancer (6.5%). Major bleeding occurred in 1.9% (5.3 events per 100 person-years), in particular, in genitourinary cancer (4.5%) and lung cancer (4.2%). Eighty deaths (17.8%) occurred during follow up.

Conclusion: In this clinical practice setting, rivaroxaban was rarely used for cancer-associated VTE. However, among those who received rivaroxaban, the treatment appeared safe and effective with rates comparable to previous studies of selected populations.

Keywords: anticoagulants; bleeding; cancer; rivaroxaban; venous thromboembolism.

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Conflict of interest statement

Associate Professor Larsen has served as an investigator for Janssen Scientific Affairs, LLC and Boehringer Ingelheim, and has been on the speaker bureaus for Bayer, BMS/Pfizer, Roche Diagnostics, Boehringer Ingelheim and Takeda Pharma. Flemming Skjøth has been consultant for Bayer. Peter Brønnum Nielsen has received speaking fees from Boehringer Ingelheim, consulting fees from Bayer; and grant support from BMS/Pfizer. Other authors – none declared.

Figures

Figure 1
Figure 1
Flow chart of the study population
Figure 2
Figure 2
Cumulative risk of recurrent venous thromboembolism (VTE) and major bleeding for 6 months of follow‐up
Figure 3
Figure 3
Flow diagram depicting the study selection process
See this image and copyright information in PMC

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