What is the clinical evidence from this study?

Study design: RCT. Population: Acute venous thromboembolism (n=2760). Intervention: Apixaban vs. Rivaroxaban (15 mg twice daily for 21 days followed by 20 mg daily). Primary outcome: Clinically relevant bleeding (composite of major bleeding or clinically relevant nonmajor bleeding) (RR 0.46, 95% CI 0.33-0.65, p=<0.001).

What question did this study set out to answer?

This research aims to compare the bleeding risk associated with apixaban and rivaroxaban in patients with acute venous thromboembolism.

April 15, 2026Open Access

Bleeding Risk with Apixaban vs. Rivaroxaban in Acute Venous Thromboembolism.

Q: What are the key findings of this study?

Apixaban significantly reduced the risk of clinically relevant bleeding compared to rivaroxaban in patients with acute venous thromboembolism (3.3% vs 7.1%; RR 0.46; 95% CI 0.33-0.65; P<0.001).

Q: What does this research mean for the field?

Apixaban significantly reduces the risk of clinically relevant bleeding compared to rivaroxaban in patients with acute venous thromboembolism. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

This research aims to compare the bleeding risk associated with apixaban and rivaroxaban in patients with acute venous thromboembolism.

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Key result

Apixaban cuts clinically relevant bleeding ~54% versus rivaroxaban in acute VTE.

RR 0.46
95% CI 0.33-0.65
P<0.001
n=2,760

Why the study?

Apixaban and rivaroxaban are the most frequently used oral anticoagulants for acute venous thromboembolism, but uncertainty remains about differences in their bleeding risk.

Does apixaban reduce clinically relevant bleeding compared to rivaroxaban in patients with acute venous thromboembolism?

Population

2760 patients with acute symptomatic pulmonary embolism or proximal deep-vein thrombosis

Comparison

Apixaban vs rivaroxaban

Design

International prospective randomized open-label blinded end-point trial

Follow-up

3 months

Authors

LCLana A Castellucci VCVivien ChenThe University of Sydney MKMichael J Kovacs

Discussion

Member takes

Implication

Favors apixaban over rivaroxaban in acute VTE; extends prior indirect evidence with dedicated head-to-head RCT.

Key Points

This research aims to compare the bleeding risk associated with apixaban and rivaroxaban in patients with acute venous thromboembolism.
International trial design
Randomized, open-label, blinded end-point assignment
1:1 ratio assignment of patients to treatment groups
Dosages: Apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily, Rivaroxaban 15 mg twice daily for 21 days followed by 20 mg daily
Measured primary outcome: clinically relevant bleeding over 3 months
Primary outcome event occurred in 3.3% of apixaban patients compared to 7.1% in rivaroxaban patients
Relative risk for bleeding with apixaban was 0.46 (95% CI: 0.33 to 0.65; P<0.001)
Death from any cause was 0.1% in apixaban group versus 0.3% in rivaroxaban
Serious adverse events unrelated to bleeding occurred similarly between groups (2.7% apixaban, 2.2% rivaroxaban)

Study Design

Type

RCT (n=2,760)

Blinding

Open-label, blinded end-point

Randomization

1:1

Multicenter

Yes

Structured PICO

Does apixaban reduce clinically relevant bleeding compared to rivaroxaban in patients with acute venous thromboembolism?

Population

2,760 patients with acute symptomatic pulmonary embolism or proximal deep-vein thrombosis in an international trial.

Intervention

Apixaban (10 mg twice daily for 7 days followed by 5 mg twice daily) for 3 months.

Comparator

Rivaroxaban (15 mg twice daily for 21 days followed by 20 mg daily) for 3 months.

Outcome

Clinically relevant bleeding, a composite of major bleeding or clinically relevant nonmajor bleeding, as defined according to the International Society on Thrombosis and Haemostasis, during the 3-month trial period.safety

Main Result

Effect estimate: RR 0.46 (95% CI 0.33-0.65)

Absolute Event Rate: 3.3% vs 7.1%

p-value: p=<0.001

In patients with acute venous thromboembolism, apixaban significantly reduced the risk of clinically relevant bleeding compared to rivaroxaban over a 3-month treatment period.

Cite This Study

Castellucci et al. (2026) conducted an RCT in Acute venous thromboembolism (n=2,760). Apixaban vs. Rivaroxaban (15 mg twice daily for 21 days followed by 20 mg daily) was evaluated on Clinically relevant bleeding (composite of major bleeding or clinically relevant nonmajor bleeding) (RR 0.46, 95% CI 0.33-0.65, p=<0.001). Apixaban significantly reduced the risk of clinically relevant bleeding compared to rivaroxaban in patients with acute venous thromboembolism (3.3% vs 7.1%; RR 0.46; 95% CI 0.33-0.65; P<0.001).

synapsesocial.com/papers/69df2c1de4eeef8a2a6b119a https://doi.org/10.48620/96858

Topics

PCSK9 inhibitors

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Bleeding Risk with Apixaban vs. Rivaroxaban in Acute Venous Thromboembolism.

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Bleeding Risk with Apixaban vs. Rivaroxaban in Acute Venous Thromboembolism.

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

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