Abstract
Objective
To compare the clinical efficacy and safety of apixaban with those of rivaroxaban
for the treatment of acute venous thromboembolism (VTE).
Patients and Methods
Consecutive patients enrolled in the Mayo Thrombophilia Clinic Registry (between March
1, 2013, and January 30, 2018) and treated with apixaban or rivaroxaban for acute
VTE were followed forward in time. The primary efficacy outcome was VTE recurrence.
The primary safety outcome was major bleeding; the second safety outcome was clinically
relevant nonmajor bleeding (CRNMB); and the third was a composite of major bleeding
or CRNMB.
Results
Within the group of 1696 patients with VTE enrolled, 600 (38%) were treated either
with apixaban (n=302, 50%) or rivaroxaban (n=298, 50%) within the first 14 days of
VTE diagnosis and who completed at least 3 months of therapy or had a study event.
Recurrent VTE was diagnosed in 7 patients (2.3%) treated with apixaban and in 6 (2%)
treated with rivaroxaban (adjusted hazard ratio [aHR], 1.4; 95% CI, 0.5-3.8). Major
bleeding occurred in 11 patients (3.6%) receiving apixaban and in 9 patients (3.0%)
receiving rivaroxaban (aHR, 1.2; 95% CI, 0.5-3.2). Clinically relevant nonmajor bleeding
was diagnosed in 7 patients (2.3%) receiving apixaban and in 20 (6.7%) receiving rivaroxaban
(aHR, 0.4; 95% CI, 0.2-0.9). The rates of composite major bleeding or CRNMB were similar
(aHR, 0.6; 95% CI, 0.3-1.2). Most study events occurred in patients with cancer.
Conclusion
In the setting of a standardized, guideline-directed, patient-oriented clinical practice,
the efficacy and safety of apixaban and rivaroxaban for the treatment of acute VTE
were comparable.
Abbreviations and Acronyms:
CRNMB (clinically relevant nonmajor bleeding), DOAC (direct oral anticoagulant), DVT (deep vein thrombosis), PE (pulmonary embolism), RCT (randomized clinical trial), VTE (venous thromboembolism)To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Mayo Clinic ProceedingsAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Oral apixaban for the treatment of acute venous thromboembolism.N Engl J Med. 2013; 369: 799-808
- Oral rivaroxaban for symptomatic venous thromboembolism.N Engl J Med. 2010; 363: 2499-2510
- Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.N Engl J Med. 2012; 366: 1287-1297
- Apixaban for extended treatment of venous thromboembolism.N Engl J Med. 2013; 368: 699-708
- Rivaroxaban or aspirin for extended treatment of venous thromboembolism.N Engl J Med. 2017; 376: 1211-1222
- Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies.Thromb J. 2013; 11: 21
- NOACs for treatment of venous thromboembolism in clinical practice.Thromb Haemost. 2017; 117: 1317-1325
- What have we learned from real-world NOAC studies in venous thromboembolism treatment?.Thromb Res. 2018; 163: 83-91
- Efficacy and safety of rivaroxaban in patients with venous thromboembolism and active malignancy: a single-center registry.Am J Med. 2016; 129: 615-619
- Rivaroxaban and apixaban for initial treatment of acute venous thromboembolism of atypical location.Mayo Clin Proc. 2018; 93: 40-47
- Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.Chest. 2012; 141 ([published correction appears in Chest. 2012;142(6):1698-1704]): e419S-e496S
- NCCN Clinical Practice Guidelines: Venous Thromboembolism Disease, Version 2.2014.NCCN, Fort Washington, PA2014: 24
- Antithrombotic therapy for VTE disease: CHEST Guideline and Expert Panel Report.Chest. 2016; 149 ([published correction appears in Chest. 2016]): 315-352
- Direct oral anticoagulants in patients with VTE and cancer: a systematic review and meta-analysis.Chest. 2015; 147: 475-483
- Edoxaban for the treatment of cancer-associated venous thromboembolism.N Engl J Med. 2018; 378: 615-624
- Simplification of the pulmonary embolism severity index for prognostication in patients with acute symptomatic pulmonary embolism.Arch Intern Med. 2010; 170: 1383-1389
- Reproducibility of clinical events adjudications in a trial of venous thromboembolism prevention.J Thromb Haemost. 2017; 15: 662-669
- Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients.J Thromb Haemost. 2005; 3: 692-694
- Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH.J Thromb Haemost. 2015; 13: 2119-2126
- Risk factors for incident venous thromboembolism in active cancer patients: a population based case-control study.Thromb Res. 2016; 139: 29-37
Article Info
Publication History
Published online: February 06, 2019
Footnotes
Grant Support: This work was partially supported by the discretionary fund from Gonda Vascular Center, Mayo Clinic Rochester, MN.
Potential Competing Interests: Dr McBane has received research grant from Bristol-Myers Squibb/Pfzier Alliance , United States of America. The other authors report no competing interests.
Identification
Copyright
© 2018 Mayo Foundation for Medical Education and Research
