Evidence map›Paper›PMID 31013383›Full record

Observational studyJournal of thrombosis and haemostasis : JTH2019

Drug levels and bleeding complications in atrial fibrillation patients treated with direct oral anticoagulants.

Sophie Testa, Cristina Legnani, Emilia Antonucci, Oriana Paoletti, Claudia Dellanoce, Benilde Cosmi, Vittorio Pengo, Daniela Poli, Rossella Morandini, Roberto Testa and 3 more

Open access · bronzeAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of thrombosis and haemostasis : JTH, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 1 pooled it
10.3field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 1 synthesis or guideline pooled it, 129 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Direct Oral Anticoagulant Transition Strategies Using Anti-Xa Concentrations Upon Intensive Care Unit Admission.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2026
    Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Observational
  13. Article
  14. The wonders of anticoagulation.Frontiers in cardiovascular medicine · 2024
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. TAVR: nemesis of NOACs?Journal of thrombosis and thrombolysis · 2023
    Article
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

13 authors at 6 institutions in 1 country.

Sophie TestaHaemostasis and Thrombosis Center, Ospedale di Cremona, Cremona, Italy.
Cristina LegnaniArianna Anticoagulazione Foundation, Bologna, Italy.
Emilia AntonucciArianna Anticoagulazione Foundation, Bologna, Italy.
Oriana PaolettiHaemostasis and Thrombosis Center, Ospedale di Cremona, Cremona, Italy.
Claudia DellanoceHaemostasis and Thrombosis Center, Ospedale di Cremona, Cremona, Italy.
Benilde CosmiAngiology and Blood Coagulation, University Hospital of Bologna, Bologna, Italy.
Vittorio PengoDepartment of Cardiac, Thoracic and Vascular Sciences, Cardiology Clinic, Thrombosis Centre, University of Padua, Padova, Italy.
Daniela PoliThrombosis Centre, AOU Careggi, Firenze, Italy.
Rossella MorandiniHaemostasis and Thrombosis Center, Ospedale di Cremona, Cremona, Italy.
Roberto TestaClinical Laboratory and Molecular Diagnosis, INRCA-IRCCS National Institute, Ancona, Italy.
Armando TripodiAngelo Bianchi Bonomi Hemophilia and Thrombosis Center, IRCCS CàGranda Maggiore Hospital Foundation, Milano, Italy.
Gualtiero PalaretiArianna Anticoagulazione Foundation, Bologna, Italy.
Coordinator of START2-Register
Istituti Ospitalieri di Cremona · ITAzienda Ospedaliero-Universitaria Careggi · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITOspedale Maggiore · ITUniversity of Bologna · ITUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Essentials Currently, DOACs are given at fixed doses and do not require laboratory monitoring. Direct oral anticoagulant-specific measurements were performed at trough and peak. Patients who developed bleeding events showed higher DOAC plasma levels at peak. This study suggests the need of a more accurate DOAC dose assessment.

backgroundDirect oral anticoagulants (DOACs) are administered at fixed dose. The aim of the study was to evaluate the relationship between DOAC C-trough or C-peak plasma levels and bleeding complications in patients with non-valvular atrial fibrillation (NVAF).

methodsFive hundred sixty five consecutive naive NVAF patients were enrolled. The DOAC measurements at C-trough and at C-peak (available in 411 patients) were performed at steady state, within the first month of treatment. Major bleeding (MB), clinically relevant non-major bleeding (CRNMB), and minor bleeding (MinB), occurring during 1 year of follow-up after blood sampling, were recorded. For each DOAC, interval of C-trough and C-peak levels was subdivided into four equal classes and results were attributed to these classes; the median values of results were also calculated.

resultsTwo hundred eight patients were on apixaban, 185 on dabigatran, and 172 on rivaroxaban. For 1-[qqqdeletezzz] year follow up for all patients, we observed: 19 MB (3.36%), 6 CRNMB (1.06%), and 47 MinB (8.31%). The prevalence of bleeding patients with anticoagulant levels in the upper classes of C-peak activity (II + III + IV) was higher than that in the lowest class. Normalized results of C-peak levels were higher in patients with bleeding than in those without bleeding.

conclusionsBleeding complications during DOAC treatment were more frequent among atrial fibrillation (AF) patients with higher C-peak anticoagulant levels. In addition to a previous study that showed an increased risk of thrombotic complications in the patients with low C-trough levels, this study seems to indicate that patients with NVAF on DOACs would need a more accurate definition of their optimal therapeutic window.

Indexed as

Administration, OralAdultAgedAged, 80 and overAntithrombinsAtrial FibrillationBlood CoagulationDabigatranDose-Response Relationship, DrugDrug MonitoringFemaleHemorrhageHumansItalyMaleMiddle AgedAntithrombinsapixabanDabigatranPyrazolesPyridonesRivaroxabanatrial fibrillationbleedsdirect oral anticoagulantlevelpeak

Identifiers

PMID31013383
PMCPMC6852698
OpenAlexW2942148541

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.