Phase 2
Completed N=76
Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
Source: ClinicalTrials.gov NCT04504318 ↗Enrolled (actual)
76
Serious AEs
2.6%
Results posted
Jun 2025
Primary outcomePrimary: Apixaban vs. Enoxaparin - Number of Participants With Bleeding Events — 1; 1 Participants
Summary
Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level factors, thus, resulting in VTE events despite guideline-compliant prophylaxis. A population at particular risk is the growing number of patients who undergo autologous breast reconstruction. Direct oral anticoagulants (DOAC) might be a less invasive, yet, more efficacious mode of chemoprophylaxis in this patient population. Hence, the proposed work has the potential to cause a paradigm shift in chemoprophylaxis guidelines in a large population of patients undergoing plastic surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apixaban vs. Enoxaparin - Number of Participants With Bleeding Events |
1; 1 | — |
| SECONDARY Apixaban vs. Enoxaparin - Number of Participants With Venous Thromboembolism (VTE) Events |
6; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult (>18 years) women
- Scheduled to undergo unilateral or bilateral microsurgical breast reconstruction with free abdominal flaps (i.e. muscle-sparing transverse rectus abdominis musculocutaneous [TRAM] and/or deep inferior epigastric artery perforator [DIEP]) flap)
- Caprini score of 6 or greater.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Contraindication to the use of apixaban or enoxaparin
- Active bleeding
- History of bleeding disorder
- History of coagulopathy
- History of heparin-induced thrombocytopenia
- History of liver disease
- History of renal disease (creatinine clearance 1.6 mg/dL)
- Major neurosurgical intervention (brain/spine) within the past 90 days
- Ophthalmologic procedure within the past 90 days
- Uncontrolled hypertension
- History of alcohol and/or substance abuse
- Need for therapeutic anticoagulation
- Pregnant or Nursing
Data sourced from ClinicalTrials.gov (NCT04504318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.