Evidence map›Paper›PMID 34987749›Full record

ArticleTherapeutic advances in drug safety2021

Do women with venous thromboembolism bleed more than men during anticoagulation? Data from the real-life, prospective START-Register.

Gualtiero Palareti, Cristina Legnani, Emilia Antonucci, Benilde Cosmi, Anna Falanga, Daniela Poli, Daniela Mastroiacovo, Vittorio Pengo, Walter Ageno, Sophie Testa

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.5field-weighted citation impact, top 16% 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

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Anticoagulant therapy for women: implications for menstruation, pregnancy, and lactation.Hematology. American Society of Hematology. Education Program · 2022
    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

10 authors at 7 institutions in 1 country.

Gualtiero Palareti'Arianna Anticoagulazione' Foundation, Via Paolo Fabbri, 1/3, 40138 Bologna, Italy.ORCID https://orcid.org/0000-0002-4327-9561
Cristina Legnani'Arianna Anticoagulazione' Foundation, Bologna, Italy.
Emilia Antonucci'Arianna Anticoagulazione' Foundation, Bologna, Italy.
Benilde CosmiUnit of Angiology & Blood Coagulation, Department of Specialty, Diagnostics & Experimental Medicine, University Hospital, IRCCS, Bologna, Italy.
Anna FalangaDipartimento di Medicina e Chirurgia, Università Milano Bicocca, Milan, Italy; UOC Immunoematologia e Medicina Trasfusionale ASST, Bergamo, Italy.
Daniela PoliSOD Malattie Aterotrombotiche, Azienda Ospedaliero Universitaria-Careggi, Firenze, Italy.
Daniela MastroiacovoDipartimento di Angiologia, Ospedale SS. Filippo e Nicola, Avezzano, Italy.
Vittorio PengoThrombosis Research Laboratory, University of Padua, Padua, Italy.
Walter AgenoDipartimento di Emergenza e Accettazione, Centro Trombosi ed Emostasi, Ospedale di Circolo, Università dell'Insubria, Varese, Italy.
Sophie TestaCentro Emostasi e Trombosi A O Istituti Ospitalieri di Cremona, Cremona, Italy.
Azienda Ospedaliero-Universitaria Careggi · ITIstituti Ospitalieri di Cremona · ITOspedale San Filippo Neri · ITUniversity of Bologna · ITUniversity of Insubria · ITUniversity of Milano-Bicocca · ITUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVenous thromboembolism (VTE) is a frequent and serious disease that requires immediate and long-term anticoagulant treatment, which is inevitably associated with a risk of bleeding complications. Some studies, though not all, reported a higher risk of bleeding in female patients treated with either old anticoagulants [vitamin k antagonists (VKAs)] or recent anticoagulants [direct oral anticoagulants (DOACs)]. Furthermore, analyses of clinical trials reported an abnormal vaginal bleeding in women of reproductive age treated with DOACs. This study aimed at comparing the risk of bleeding in an inception cohort of VTE women and men included in a prospective observational registry.

methodsBaseline characteristics and bleeding events occurring during anticoagulation in patients of both sexes, included in the START-Register after a first VTE, were analyzed.

resultsIn all, 1298 women were compared with 1290 men. Women were older and more often had renal diseases; their index events were often provoked (often by hormonal contraception and pregnancy), and more frequently presented as isolated pulmonary embolism (PE). The rate of bleeding was similar in women (2.9% patient-years) and men (2.1% patient-years), though it was higher when uterine bleeds were included (3.5% patient-years,

conclusionThe occurrence of bleeding was not different between women and men during anticoagulation after VTE. Only after inclusion of vaginal/uterine bleeds, the rate of bleeding was higher in women. The incidence of bleeding was higher in women treated with VKAs. PLAIN LANGUAGE SUMMARY:

Indexed as

anticoagulationbleedingvenous thromboembolismwomen

Identifiers

PMID34987749
PMCPMC8689616
OpenAlexW4205788956

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.