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Ney Carter Borges: A Safety Advantage of Apixaban over Rivaroxaban Without Clear Superiority
Ney Carter Borges/LinkedIn
Mar 11, 2026, 23:05

Ney Carter Borges: A Safety Advantage of Apixaban over Rivaroxaban Without Clear Superiority

Ney Carter Borges, Member Cardiologist of Global Physician Association at Cleveland Clinic Florida, shared a post on LinkedIn about a recent article by Lana Castellucci et al, published in NEJM:

”COBRRA Trial – Apixaban vs Rivaroxaban in Acute Venous Thromboembolism

Main Clinical Findings

  • Primary outcome (clinically relevant bleeding, 3 months)
  • Apixaban: 3.3%
  • Rivaroxaban: 7.1%
  • Relative Risk: 0.46
  • 95% CI: 0.33–0.65
  • P < 0.001
  • Major bleeding
  • Apixaban: 0.4%
  • Rivaroxaban: 2.4%
  • RR: 0.16
  • Recurrent VTE
  • Apixaban: 1.1%
  • Rivaroxaban: 1.0%
  • RR: 1.08 (no meaningful difference)

Critical Appraisal

Strengths (Positive Aspects)

1. Direct head-to-head randomized comparison
Until this trial, most comparisons between DOACs came from indirect network meta-analyses or observational cohorts.

2. Clinically meaningful endpoint
The primary endpoint included major bleeding and clinically relevant non-major bleeding, which reflects real-world complications affecting treatment continuation.

3. Robust reduction in bleeding risk
The absolute risk reduction of 3.8% yields an NNT ≈ 26 to prevent one bleeding event within 3 months.

4. Large pragmatic multicenter design

  • 2760 patients
  • 32 centers
  • Real-world acute VTE population.

5. Blinded adjudication of outcomes
Even though the trial was open-label, events were adjudicated blindly, reducing measurement bias.

6. Clinically actionable findings
Results provide clear guidance for first-line DOAC selection in acute VTE.

Limitations (Negative Aspects)

1. Open-label design
Treatment allocation was not blinded, which may introduce behavioral or reporting bias.

2. Study not powered for efficacy equivalence
The trial was designed primarily for bleeding safety, not to prove non-inferiority for recurrent VTE.

3. Limited generalizability

Underrepresented populations:

  • severe obesity (>120 kg)
  • active cancer-associated thrombosis
  • advanced renal disease

4. Geographic concentration
Most participants were recruited in Canada, limiting external validity across broader populations.

5. Dosing strategy difference

The higher bleeding with rivaroxaban may partly reflect:

  • Initial intensified dosing phase (15 mg BID), rather than intrinsic drug toxicity.

6. Short follow-up
Primary analysis focused on 3 months, which corresponds to the acute treatment phase but not long-term anticoagulation.

Clinical Interpretation

This trial suggests that apixaban may offer a superior safety profile compared with rivaroxaban during the initial treatment phase of VTE, without compromising thromboembolic protection.

However, the results do not definitively establish superiority in overall efficacy, nor do they fully apply to populations such as cancer-associated thrombosis or extreme obesity.”

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

Authors: Lana A. Castellucci, Vivien M. Chen, Michael J. Kovacs, Alejandro Lazo-Langner, Peter Greenstreet, Susan Kahn, Benoit Côté, Sam Schulman, Kerstin de Wit, James Douketis, Deepa Suryanarayan, Tony Wan, Erik Yeo, Genevieve Le Templier, Huyen A. Tran, Abbey Willcox, Helen J. Crowther, Ritam Prasad, Sudeep Shivakumar, Etimbuk Umana, Fionnuala Ni Ainle, Tobias Tritschler, Stefano Barco, Jean-Philippe Galanaud, Marc Blondon, Lisa Baumann Kreuziger, Susan Solymoss, Clive Kearon, Erin Thomas, Tim Ramsay, Gregoire Le Gal, Marc Rodger, for the COBRRA Trial Investigators

Read the Full Article on NEJM

Ney Carter Borges: A Safety Advantage of Apixaban over Rivaroxaban Without Clear Superiority

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Abbey Willcox Alejandro Lazo-Langner Apixaban Benoit Côté Clive Kearon COBRRA Deepa Suryanarayan DOACs DVT Erik Yeo Erin Thomas Etimbuk Umana Fionnuala Ní Áinle Genevieve Le Templier Gregoire Le Gal Health Helen J. Crowther Hematology Hemostasis Hemostasis News Hemostasis Today Huyen A. Tran James Douketis Jean-Philippe Galanaud Kerstin de Wit Lana A. Castellucci Lisa Baumann Kreuziger Marc Blondon Marc Rodger Medicine Michael J. Kovacs NEJM Ney Carter Borges Peter Greenstreet Ritam Prasad Rivaroxaban Sam Schulman Stefano Barco Sudeep Shivakumar Susan Kahn Susan Solymoss thrombosis Tim Ramsay Tobias Tritschler Tony Wan Vivien M. Chen VTE
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