Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

Study Overview
=================
Brief 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.

Official Title
-----------------
A Randomized Controlled Trial Comparing Apixaban Versus Enoxaparin Following Microsurgical Breast Reconstruction

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: Apixaban 2.5 MG Oral Tablet
* Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe


Participation Criteria
=================
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. 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 <30 mL/min; serum creatinine >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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apixaban<br>Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure. | Drug: Apixaban 2.5 MG Oral Tablet<br>* Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.<br>|
| Active Comparator: Enoxaparin<br>Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure. | Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe<br>* Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apixaban vs. Enoxaparin - Bleeding event | To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction | 90-day events | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apixaban vs. Enoxaparin - Venous Thromboembolism (VTE) event | To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction | 90-day events |