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

Autor:	McBane RD 2nd; Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota, USA. Electronic address: mcbane.robert@mayo.edu., Loprinzi CL; Department of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA., Zemla T; Clinical Trials and Biostatistics, Mayo Clinic, Rochester, Minnesota, USA., Tafur A; Cardiovascular Division, North Shore University Health System, Evanston, Illinois, USA., Sanfilippo K; Hematology and Medical Oncology, Siteman Cancer Center, Washington University, St. Louis, Missouri, USA., Liu JJ; Hematology and Medical Oncology, Illinois Cancer Care, Peoria, Illinois, USA., Garcia DA; Hematology Division, University of Washington, Seattle, Washington, USA., Heun J; Dean Hematology and Medical Oncology Group, Madison, Wisconsin, USA., Gundabolu K; Hematology and Medical Oncology, University of Nebraska Medical Center, Omaha, Nebraska, USA., Onitilo AA; Hematology and Medical Oncology, Cancer Care & Research Center, Marshfield Clinic, Marshfield, Wisconsin, USA., Perepu U; Hematology and Medical Oncology, University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, USA., Drescher MR; Cardiovascular Medicine, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USA., Henkin S; Cardiovascular Medicine, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USA., Houghton D; Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota, USA., Ashrani A; Hematology Division, Mayo Clinic, Rochester, Minnesota, USA., Billett H; Montefiore Medical Center, Bronx, New York, USA., McCue SA; Clinical Trials and Biostatistics, Mayo Clinic, Rochester, Minnesota, USA., Lee MK; Clinical Trials and Biostatistics, Mayo Clinic, Rochester, Minnesota, USA., Le-Rademacher JG; Clinical Trials and Biostatistics, Mayo Clinic, Rochester, Minnesota, USA., Wysokinski WE; Vascular Medicine Division, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota, USA.
Jazyk:	angličtina
Zdroj:	Journal of thrombosis and haemostasis : JTH [J Thromb Haemost] 2024 Jun; Vol. 22 (6), pp. 1704-1714. Date of Electronic Publication: 2024 Mar 25.
DOI:	10.1016/j.jtha.2024.03.011
Abstrakt:	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). Competing Interests: Declaration of competing interests The authors declare no competing financial interests. (Copyright © 2024 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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