Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

Stanford University82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Venous Thromboembolism

Interventions

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.

Enoxaparin 40Mg/0.4mL Prefilled SyringeDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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 \<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 * Pregnant or Nursing

Outcomes

Primary Outcomes

Apixaban vs. Enoxaparin - Number of Participants With Bleeding Events

To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction

Time frame: 90-day events

Secondary Outcomes

Apixaban vs. Enoxaparin - Number of Participants With Venous Thromboembolism (VTE) Events

To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction

Time frame: 90 days