Evidence map›Paper›PMID 40546068›Full record

Trial reportCirculation2025

Abelacimab Versus Rivaroxaban in Patients With Atrial Fibrillation on Antiplatelet Therapy: A Prespecified Analysis of the AZALEA-TIMI 71 Trial.

Samer Al Said, Siddharth M Patel, Robert P Giugliano, David A Morrow, Erica L Goodrich, Sabina A Murphy, Bruce Hug, Sanobar Parkar, Shih-Ann Chen, Shaun G Goodman and 7 more

Registry-linked trialAbstract readRandomized Controlled TrialComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04755283 (A Multicenter, RandomiZed, Active-ControLled Study to Evaluate the Safety and Tolerability of Two Blinded Doses of Abelacimab), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04755283 phase2active not recruitingnot on this map

A Multicenter, RandomiZed, Active-ControLled Study to Evaluate the Safety and Tolerability of Two Blinded Doses of Abelacimab (MAA868) Compared With Open-Label Rivaroxaban in Patients With Atrial Fibrillation (AZALEA)

TypeinterventionalSponsorAnthos Therapeutics, Inc.Ran2021 to 2028Enrolled1,287ConditionsAtrial Fibrillation (AF), StrokeArmsAbelacimab, Rivaroxaban
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Review
  3. TheResearch and practice in thrombosis and haemostasis · 2026
    Article
  4. Review
  5. Cerebral venous thrombosis: Current management, recent advances and future directions.International journal of stroke : official journal of the International Stroke Society · 2025
    Review
  6. Review
  7. Review
  8. Abelacimab for Acute Pulmonary Embolism: Translating Dual FXI/XIa Inhibition from Mechanism to Clinical Prospects.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Samer Al Said *TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.A.S., S.M.P., R.P.G., D.A.M., E.L.G., S.A.M., M.S.S., C.T.R.).ORCID 0000-0002-3262-3785
Siddharth M Patel *TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.A.S., S.M.P., R.P.G., D.A.M., E.L.G., S.A.M., M.S.S., C.T.R.).ORCID 0000-0002-4637-4361
Robert P GiuglianoTIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.A.S., S.M.P., R.P.G., D.A.M., E.L.G., S.A.M., M.S.S., C.T.R.).ORCID 0000-0003-4110-7675
David A MorrowTIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.A.S., S.M.P., R.P.G., D.A.M., E.L.G., S.A.M., M.S.S., C.T.R.).ORCID 0000-0002-9589-5382
Erica L GoodrichTIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.A.S., S.M.P., R.P.G., D.A.M., E.L.G., S.A.M., M.S.S., C.T.R.).ORCID 0000-0002-8541-264X
Sabina A MurphyTIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.A.S., S.M.P., R.P.G., D.A.M., E.L.G., S.A.M., M.S.S., C.T.R.).ORCID 0000-0002-8231-3611
Bruce HugAnthos Therapeutics, Inc, Cambridge, MA (B.H., S.P., D.B.).
Sanobar ParkarAnthos Therapeutics, Inc, Cambridge, MA (B.H., S.P., D.B.).
Shih-Ann ChenHeart Rhythm Center, Taipei Veterans General Hospital, Taiwan (S.-A.C.).ORCID 0000-0001-9085-0823
Shaun G GoodmanDivision of Cardiology, Department of Medicine, St Michael's Hospital, Unity Health Toronto, University of Toronto, Canada (S.G.G.).ORCID 0000-0001-8068-2440
Boyoung JoungDivision of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (B.J.).ORCID 0000-0001-9036-7225
Robert G KissDepartment of Cardiology, Central Hospital of Northern Pest-Military Hospital, Heart and Vascular Center, Semmelweis University, Budapest, Hungary (R.G.K.).ORCID 0000-0003-0514-7530
Wojciech WojakowskiDivision of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland (W.W.).ORCID 0000-0002-3681-5207
Jeffrey I WeitzThrombosis and Atherosclerosis Research Institute, Hamilton Health Sciences, and McMaster University, Hamilton, Canada (J.I.W.).ORCID 0000-0002-1092-7550
Dan BloomfieldAnthos Therapeutics, Inc, Cambridge, MA (B.H., S.P., D.B.).
Marc S SabatineTIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.A.S., S.M.P., R.P.G., D.A.M., E.L.G., S.A.M., M.S.S., C.T.R.).ORCID 0000-0002-0691-3359
Christian T RuffTIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.A.S., S.M.P., R.P.G., D.A.M., E.L.G., S.A.M., M.S.S., C.T.R.).ORCID 0000-0002-4712-3206

Funding

CTSA K12 Program at Harvard Medical SchoolK12TR004381 · NCATS · HARVARD MEDICAL SCHOOL · PI Karen K Miller · 2023 to 2026
$6.5M
NCATS NIH HHS K12 TR004381
6 · The paper itself

Abstract

backgroundCombining antiplatelet therapy (APT) with conventional anticoagulants increases the risk of bleeding. In the AZALEA-TIMI 71 trial (Safety and Tolerability of Abelacimab [MAA868] vs Rivaroxaban in Patients With Atrial Fibrillation), the novel factor XI inhibitor abelacimab significantly reduced the risk of bleeding compared with rivaroxaban in patients with atrial fibrillation. Whether the safety of combination antithrombotic therapy differs in the context of factor XI inhibition has not been well characterized.

methodsThis prespecified analysis of AZALEA-TIMI 71, which randomized patients between March and December of 2021 to 1 of 2 subcutaneous monthly abelacimab doses (90 or 150 mg) or oral rivaroxaban (20 mg daily, dose reduced to 15 mg in patients with creatinine clearance ≤50 mL/min), stratified patients by planned use of concomitant APT. The primary composite end point of major or clinically relevant nonmajor bleeding and other safety and efficacy outcomes were examined by concomitant APT and randomized treatment.

resultsOf 1287 patients (44% female; median age 74 years [interquartile range, 69-78]), 318 (24.7%) were on APT at baseline with planned continuation (15.5% aspirin only, 7.5% P2Y

conclusionsInhibition of factor XI with abelacimab consistently reduced bleeding compared with rivaroxaban regardless of concomitant APT use, with greater absolute reductions in bleeding in those requiring concomitant APT. These data suggest that factor XI inhibition may be a safe anticoagulant option in patients with atrial fibrillation requiring concomitant APT. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04755283.

Indexed as

Antibodies, Monoclonal, HumanizedAtrial FibrillationFactor Xa InhibitorsPlatelet Aggregation InhibitorsRivaroxabanAgedAged, 80 and overDrug Therapy, CombinationFemaleHemorrhageHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedFactor Xa InhibitorsPlatelet Aggregation InhibitorsRivaroxabananticoagulantsatrial fibrillationblood coagulationFactor XIhemorrhageplatelet aggregation inhibitors

Identifiers

PMID40546068
PMCPMC12668221

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.