Extending venous thromboembolism secondary prevention with apixaban in cancer patients. The EVE trial

EVE trial investigators, Robert D. McBane, Charles L. Loprinzi, Tyler Zemla, Alfonso Tafur, Kristen Sanfilippo, Jane Jijun Liu, David A. Garcia, James Heun, Krishna Gundabolu, Adedayo A. Onitilo, Usha Perepu, Monic R. Drescher, Stanislav Henkin, Damon Houghton, Aneel Ashrani, Henny Billett, Shaylene A. McCue, Minji K. Lee, Jennifer G. Le-RademacherWaldemar E. Wysokinski

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

Background: Cancer-associated venous thromboembolism (VTE) management guideline recommendations include continued therapeutic anticoagulation while active cancer persists. The Federal Drug Administration label for apixaban for secondary VTE prevention includes a dose reduction to 2.5 mg twice daily after 6 months of treatment. Objectives: The study's purpose was to determine whether this dose reduction is advisable for cancer-associated VTE. Methods: A randomized, double-blind trial compared apixaban 2.5 mg with 5 mg twice daily for 12 months among cancer patients with VTE who had completed 6 to 12 months of anticoagulation therapy. The primary outcome was combined major bleeding plus clinically relevant nonmajor bleeding. Results: Of 370 patients recruited, 360 were included in the intention-to-treat analyses. Major plus clinically relevant nonmajor bleeding occurred in 16 of 179 patients (8.9%) in the apixaban 2.5 mg group compared with 22 of 181 patients (12.2%) in the 5 mg group (hazard ratio [HR], 0.72; 95% CI, 0.38-1.37; P = .39). Major bleeding occurred in 2.8% of the apixaban 2.5 mg group and in 2.2% of the 5 mg group (HR, 1.26; 95% CI, 0.34-4.66; P = .73). Recurrent VTE or arterial thrombosis occurred in 9 of 179 patients (5.0%) in the apixaban 2.5 mg group and 9 of 181 patients (5.0%) in the 5 mg group (HR, 1.0; 95% CI, 0.40-2.53; P = 1.00). All-cause mortality rates were similar between groups, 13% vs 12% (HR, 1.14; 95% CI, 0.63-2.04; P = .67). Conclusion: For secondary prevention of cancer-associated VTE, apixaban 2.5 mg compared with 5 mg twice daily did not lower combined bleeding events (EVE trial NCT03080883).

Original languageEnglish
Pages (from-to)1704-1714
Number of pages11
JournalJournal of Thrombosis and Haemostasis
Volume22
Issue number6
DOIs
StatePublished - Jun 2024

Keywords

  • apixaban
  • cancer
  • secondary prevention
  • venous thromboembolism

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