LB 02.1 - Extending Venous Thromboembolism Secondary Prevention with Apixaban in Cancer Patients. The EVE Trial.

Tuesday, June 27, 2023

10:45 – 11:00 ET

Room: 517

Session Available As: Live-Streamed and On-Demand

Presenting Author(s)

Robert D. McBane, II, MD

Physician
Mayo Clinic
Rochester, Minnesota, United States

Co-Author(s)

CL

Charles Loprinzi

Physician
Mayo Clinic
Rochester, Minnesota, United States
SD

Shaker Dakhil

Physician
Cancer Center of Kansas
Wichita, Kansas, United States
AO

Adedayo Onitilo

Physician
Marshfield Clinic
Marshfield, Wisconsin, United States
KG

Krishna Gundabolu

Physician
University of Nebraska Medical Center
Omaha, Nebraska, United States
MD

Monic Drescher

Physician
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
MM

Micah Mooberry

Physician
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
AN

Arun Nagarajan

Physician
Cleveland Clinic
Weston, Florida, United States
DG

David Garcia

Professor
Division of Hematology, Department of Medicine, University of Washington, Seattle, WA, USA
Seattle, Washington, United States
JL

Jane Liu

Physician
Illinois CancerCare
Peoria, Illinois, United States
Kristen Sanfillipo, MD, MPHS

Assistant Professor
Washington University St. Louis School of Medicine
Saint Louis, Missouri, United States
AT

Alfonso Tafur, MD, MS, MBA (he/him/his)

Attending Physician, Senior Author
Northshore University HealthSystem, Cardiovascular Institute
Evanston, Illinois, United States
SH

Stanislav Henkin

Physician
Dartmouth Hitchcock
Lebanon, New Hampshire, United States
CK

Charles Kuzma

Physician
First Health
Pinehurst, North Carolina, United States
JH

James Heun

Physician
SSM Health Dean Medical Group
Madison, Wisconsin, United States
JK

John Krauss

Phycisian
University of Michigan
Ann Arbor, Michigan, United States
TZ

Tyler Zemla

Biostatistician
Mayo Clinc
Rochester, Minnesota, United States
SM

Shaylene McCue

Biostatistician
Mayo Clinic
Rochester, Minnesota, United States
Damon E. Houghton, MD, MS

Vascular Medicine Specialist
Mayo Clinic
Rochester, Minnesota, United States
WW

Waldemar E. Wysokinski

Cardiologist & Vascular Medicine Specialist
Mayo Clinic
Rochester, Minnesota, United States

Background: The FDA label for apixaban for prevention of venous thromboembolism (VTE) recurrence includes a dose reduction to 2.5 mg twice daily after 6 months of anticoagulation therapy. Whether this dose reduction is advisable for cancer associated VTE is unknown.

Aims: We tested the hypothesis that apixaban 2.5 mg twice daily is associated with a lower combined rate of major bleed plus clinically relevant nonmajor bleeding (CRNMB) compared to apixaban 5 mg twice daily for the secondary prevention of VTE in patients with active cancer who have completed 6 to 12 months of anticoagulation.

Methods: This phase III, multicenter, randomized, double-blind, investigator-initiated, trial assessed combined rates of major bleeding plus CRNMB (primary outcome). Treatment duration was 12 months. Secondary outcomes were VTE recurrence or arterial thromboembolism.

Results: Of 370 patients recruited, the results from 360 were analyzed. The four most common tumor sites were gastrointestinal, lung, hematologic, and breast malignancies; 59.7% had metastasis. Major plus CRNMB occurred in 16 of 179 patients (8.9%) in the apixaban 2.5 mg group and in 22 of 179 patients (12.2%) in the 5 mg group (HR 0.72, 95% CI 0.38-1.37, p=0.31). Major bleeding occurred in 2.8% of the apixaban 2.5 mg group and 2.2% in the 5 mg group (HR 1.26, 95% CI 0.34-4.66, p=0.73). Recurrent VTE or arterial thrombosis occurred in 9 patients (5.0%) of each treatment group (HR 1.0 95% CI 0.40 – 2.53, p=0.81). All-cause mortality rates were similar between groups, 13.6% vs. 11.7% (HR 1.21, 95% CI 0.67 – 2.18; p=0. 53).

Conclusion(s): Apixaban 2.5 mg twice daily among cancer patients with VTE resulted in similar rates of bleeding compared to 5 mg without increasing thrombotic outcomes.