Bleeding Risk With Apixaban Versus Rivaroxaban in Acute Pulmonary Embolism

Background: Direct oral anticoagulants (DOACs) are recommended for most eligible patients with acute venous thromboembolism, but comparative bleeding data for apixaban versus rivaroxaban in South Asian populations remain limited. This study will address this knowledge gap by providing direct randomized evidence from a Pakistani cohort.

Study Design: Single-center, prospective, open-label, randomized controlled trial with 1:1 allocation.

Interventions:

Apixaban Group: 10 mg twice daily for 7 days, followed by 5 mg twice daily for the remainder of 3 months

Rivaroxaban Group: 15 mg twice daily for 21 days, followed by 20 mg once daily for the remainder of 3 months

Follow-up Duration: 3 months with monthly assessments

Primary Endpoint: Composite of major bleeding or clinically relevant non-major (CRNM) bleeding within 3 months

Secondary Endpoints: (To be confirmed against protocol)

Major bleeding alone

CRNM bleeding alone

Recurrent venous thromboembolism

All-cause mortality

Inclusion criteria

• CT pulmonary angiography-confirmed acute PE
• Intraluminal pulmonary arterial filling defect

Exclusion criteria

• Hemophilia or other bleeding disorder
• Known platelet disorder
• Previous major bleeding
• Active bleeding
• Pregnancy or lactation
• Creatinine clearance < 30 mL/min
• Indication for therapeutic anticoagulation other than VTE