Trial Outcomes & Findings for Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT (NCT NCT04504318)

NCT ID: NCT04504318

Last Updated: 2025-06-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 82 participants
• Primary outcome timeframe: 90-day events
• Results posted on: 2025-06-22

Participant Flow

82 participants signed informed consent; 76 were allocated to treatment.

Participant milestones

Measure	Apixaban Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.	Enoxaparin Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.
Overall Study STARTED	37	39
Overall Study COMPLETED	37	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Apixaban n=37 Participants Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.	Enoxaparin n=39 Participants Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=39 Participants	0 Participants n=76 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=37 Participants	33 Participants n=39 Participants	67 Participants n=76 Participants
Age, Categorical >=65 years	3 Participants n=37 Participants	6 Participants n=39 Participants	9 Participants n=76 Participants
Age, Continuous	53 years STANDARD_DEVIATION 10 • n=37 Participants	53 years STANDARD_DEVIATION 11 • n=39 Participants	53 years STANDARD_DEVIATION 0 • n=76 Participants
Sex: Female, Male Female	37 Participants n=37 Participants	39 Participants n=39 Participants	76 Participants n=76 Participants
Sex: Female, Male Male	0 Participants n=37 Participants	0 Participants n=39 Participants	0 Participants n=76 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	37 Participants n=37 Participants	39 Participants n=39 Participants	76 Participants n=76 Participants

PRIMARY outcome

Timeframe: 90-day events

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

Outcome measures

Measure	Apixaban n=37 Participants Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.	Enoxaparin n=39 Participants Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.
Apixaban vs. Enoxaparin - Number of Participants With Bleeding Events	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 90 days

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

Outcome measures

Measure	Apixaban n=37 Participants Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.	Enoxaparin n=39 Participants Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.
Apixaban vs. Enoxaparin - Number of Participants With Venous Thromboembolism (VTE) Events	6 Participants	5 Participants

Adverse Events

Apixaban

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Enoxaparin

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Apixaban n=37 participants at risk Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.	Enoxaparin n=39 participants at risk Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.
Surgical and medical procedures Bleeding Event	2.7% 1/37 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.	2.6% 1/39 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.

Other adverse events

Measure	Apixaban n=37 participants at risk Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.	Enoxaparin n=39 participants at risk Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.
Surgical and medical procedures Cellulitis at donor site (abdomen)	2.7% 1/37 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.	2.6% 1/39 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.
Surgical and medical procedures Wound dehsicence at breast	2.7% 1/37 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.	2.6% 1/39 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.
Surgical and medical procedures Breast Cellulitis	2.7% 1/37 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.	2.6% 1/39 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.
Surgical and medical procedures Mastectomy skin necrosis	2.7% 1/37 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.	2.6% 1/39 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.
Surgical and medical procedures Wound deshiscence at abdomen	2.7% 1/37 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.	0.00% 0/39 • Adverse event data was collected for 90 days from the surgery date.
Surgical and medical procedures Hematoma	2.7% 1/37 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.	2.6% 1/39 • Number of events 1 • Adverse event data was collected for 90 days from the surgery date.

Additional Information

Dr. Arash Momeni

Stanford University

Phone: 650-723-6189

Email: amomeni@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place