Evidence map›Paper›PMID 38842448›Full record

Observational studyBlood advances2024

More early bleeds associated with high baseline direct oral anticoagulant levels in atrial fibrillation: the MAS study.

Gualtiero Palareti, Sophie Testa, Cristina Legnani, Claudia Dellanoce, Michela Cini, Oriana Paoletti, Antonio Ciampa, Emilia Antonucci, Daniela Poli, Rossella Morandini and 12 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Blood advances, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03803579 (Baseline DOAC Measurement in Non Valvular Atrial Fibrillation Patients and Incidence of Bleeding or Thromboembolic Complications During Follow-up), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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.

NCT03803579 completednot on this map

Baseline DOAC Measurement in Non Valvular Atrial Fibrillation Patients and Incidence of Bleeding or Thromboembolic Complications During Follow-up: a Prospective, Multicenter, Observational Study. The MAS (Measure And See) Study

TypeobservationalSponsorArianna Anticoagulazione FoundationRan2018 to 2023Enrolled2,000ConditionsAtrial Fibrillation, Anticoagulant-induced Bleeding
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Is Laboratory Monitoring Useful in DOAC Management?Mediterranean journal of hematology and infectious diseases · 2025
    Article
  10. Direct oral anticoagulants measurement: when is it necessary?Blood transfusion = Trasfusione del sangue · 2025
    Article
  11. Article
  12. The wonders of anticoagulation.Frontiers in cardiovascular medicine · 2024
    Article
  13. Oral Anticoagulants in Women: What's the Difference? A Narrative Review.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Gualtiero PalaretiFondazione Arianna Anticoagulazione, Bologna, Italy.ORCID 0000-0002-4327-9561
Sophie TestaCentro Emostasi e Trombosi, Laboratorio Analisi Chimico-Cliniche e Microbiologiche, ASST Cremona, Cremona, Italy.
Cristina LegnaniFondazione Arianna Anticoagulazione, Bologna, Italy.ORCID 0000-0003-1999-7800
Claudia DellanoceCentro Emostasi e Trombosi, Laboratorio Analisi Chimico-Cliniche e Microbiologiche, ASST Cremona, Cremona, Italy.ORCID 0009-0001-5704-953X
Michela CiniFondazione Arianna Anticoagulazione, Bologna, Italy.ORCID 0000-0001-9681-6159
Oriana PaolettiCentro Emostasi e Trombosi, Laboratorio Analisi Chimico-Cliniche e Microbiologiche, ASST Cremona, Cremona, Italy.ORCID 0000-0002-4927-0031
Antonio CiampaCentro Emostasi, UOC Laboratorio Analisi, Ospedale S.G. Moscati, Avellino, Italy.
Emilia AntonucciFondazione Arianna Anticoagulazione, Bologna, Italy.ORCID 0000-0001-9185-2046
Daniela PoliMalattie Aterotrombotiche, AOU Careggi, Florence, Italy.
Rossella MorandiniCentro Emostasi e Trombosi, Laboratorio Analisi Chimico-Cliniche e Microbiologiche, ASST Cremona, Cremona, Italy.ORCID 0009-0008-0025-1770
Maurizio TalaCentro Emostasi e Trombosi, Laboratorio Analisi Chimico-Cliniche e Microbiologiche, ASST Cremona, Cremona, Italy.ORCID 0009-0007-5842-9036
Paolo ChiarugiUO di Analisi Chimico Cliniche, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
Rita Carlotta SantoroCentro Emostasi e Trombosi, UO Emofilia e Patologie della Coagulazione, Dipartimento di Ematologia, Oncologia e Medicina Trasfusionale, Azienda Ospedaliera "Pugliese Ciaccio," Catanzaro, Italy.ORCID 0000-0002-5081-8201
Angela Maria IannoneUOSVD Sezione Trasfusionale, Ospedale Don Tonino Bello, Bari, Italy.
Erica De CandiaUOSD Malattie Emorragiche e Trombotiche, Dipartimento Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0003-0942-2819
Pasquale PignatelliUOC Medicina Interna e Prevenzione dell'Aterosclerosi, Dipartimento di Medicina Interna e Specialità Mediche, Azienda Ospedaliero-Universitaria Policlinico Umberto I, Rome, Italy.ORCID 0000-0002-2265-7455
Elena Maria FaioniServizio Immunologia e Medicina Trasfusionale, Ospedale San Paolo, ASST Santi Paolo e Carlo, Milan, Italy.ORCID 0000-0001-8731-6531
Antonio ChistoliniUO Medicina Traslazionale e di Precisione, Dipartimento Medicina Interna e Specialità Mediche, Azienda Ospedaliero-Universitaria Policlinico Umberto I, Rome, Italy.ORCID 0000-0002-2593-1376
Maria Del Pilar EstebanUO Laboratorio Analisi, Dipartimento dei Servizi Diagnostici, Ospedale Oglio Po, ASST Cremona, Cremona, Italy.
Marco MariettaStruttura Complessa di Ematologia, Policlinico di Modena, Azienda Ospedaliera Universitaria di Modena, Modena, Italy.
Armando TripodiCentro Emofila e Trombosi Angelo Bianchi Bonomi, presso la Fondazione IRCCS Ca' Granda Ospedale Maggiore, Milan, Italy.
Alberto TosettoUOC Ematologia, Centro Malattie Emorragiche e Trombotiche, AULSS 8 Berica Ospedale S. Bortolo, Vicenza, Italy.ORCID 0000-0002-0119-5204

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractTreatment with direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) is effective and safe. However, bleeding complications still occur. Whether DOAC level measurement may further improve treatment efficacy and safety is still an open issue. In the "Measure and See" study, venous blood was collected 15-30 days after DOAC initiation in patients with AF who were then followed up for 1 year to record the occurrence of major and clinically relevant nonmajor bleeding. DOAC plasma levels were measured in 1 laboratory, and results were kept blind to patients and treating doctors. Trough DOAC levels were assessed in 1657 patients (957 [57.7%] and 700 patients treated with standard and low-dose, respectively). Fifty bleeding events were recorded during 1606 years of follow-up (3.11% pt/yrs). Fifteen bleeding events (4.97% pt/yrs) occurred in patients with C-trough standardized values in the highest activity class (>0.50), whereas 35 events (2.69% pt/yrs) occurred in those with values in the 2 lower classes (≤0.50, P = .0401). Increasing DOAC levels and low-dose DOAC use were associated with increased bleeding risk in the first 3 months of treatment. Overall, 19% of patients receiving low doses had standardized values in the highest class. More bleeding occurred in patients on low (4.3% pt/yrs) vs standard (2.2% pt/yrs; P = .0160) dose DOAC. Early measurement of DOAC levels in patients with AF identified many individuals with high levels despite the low doses use and had more bleeding risk during the first 3 months of treatment. This trial was registered at www.ClinicalTrials.gov as #NCT03803579.

Indexed as

AnticoagulantsAtrial FibrillationHemorrhageAdministration, OralAgedAged, 80 and overFactor Xa InhibitorsFemaleHumansMaleMiddle AgedAnticoagulantsFactor Xa Inhibitors

Identifiers

PMID38842448
PMCPMC11421315

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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.