Evidence map›Paper›PMID 39438090›Full record

Observational studyBMJ open2024

Assessment of bleeding events in patients receiving DOACs with or without statins to treat venous thromboembolism: insights from the RIETE registry.

Rosaria Del Giorno, Lucia Mazzolai, Sanjiv Keller, Carmine Siniscalchi, Luciano Lopez-Jimenez, Aitor Ballaz, Ana Cristina Montenegro, Remedios Otero, Farid Rashidi, Manuel Monreal and 1 more

Abstract readObservational StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMJ open, 2024. 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
–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.

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.

  1. Article
  2. Article
  3. Article
  4. 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

11 authors.

Rosaria Del GiornoAngiology, CHUV, Lausanne, Switzerland rosaria.delgiorno@eoc.ch.ORCID 0000-0001-5206-8865
Lucia MazzolaiAngiologiy, CHUV, Lausanne, Switzerland.
Sanjiv KellerAngiologiy, CHUV, Lausanne, Switzerland.
Carmine SiniscalchiUniversità degli Studi di Parma, Parma, Italy.
Luciano Lopez-JimenezHospital Universitario Reina Sofía, Cordoba, Spain.
Aitor BallazHospital de Galdakao-Usansolo, Galdakao, Spain.
Ana Cristina MontenegroHospital Universitario de la Fundación Santa Fe de Bogotá, Bogota, Colombia.
Remedios OteroInstituto de Biomedicina de Sevilla, Sevilla, UK.
Farid RashidiDepartment Pulmonary and Critical Care, Imam Reza Hospital, Tabiz, Iran (the Islamic Republic of).
Manuel MonrealUniversidad Católica de Murcia, Murcia, Spain.
RIETE Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the impact of coadministering statins with direct oral anticoagulants (DOACs) on the risk of major bleeding events in patients with venous thromboembolism (VTE).

designObservational cohort analysis based on a multicentre international registry.

settingData were extracted from the Registro Informatizado de Enfermedad TromboEmbolica Registry, which involves 205 centres across 27 countries.

participantsA total of 73 659 patients diagnosed with VTE were classified based on their anticoagulant therapy (DOACs) versus low-molecular-weight heparin (LMWH) or vitamin K antagonists (VKAs) and concurrent use of statins.

methodsMultivariable Cox proportional hazards models adjusted for confounding variables to assess the risk of major bleeding events stratified by the type of anticoagulant use and statin use.

resultsFrom October 2013 to February 2023, 73 659 patients were recruited: 2573 were statin users on DOACs, 14 090 were statin users on LMWH or VKA therapy, 10 088 were non-statin users on DOACs and 46 908 were non-statin users on LMWH or VKA therapy. Statin users were 10 years older and more likely to have hypertension, diabetes, renal failure or prior artery disease. During anticoagulation (median, 187 days), 1917 patients (2.6%) suffered major bleeding. Rates of major bleeding per 100 patient-years were 2.33 (95% CI 1.72 to 3.09), 3.75 (95% CI 3.43 to 4.10), 1.39 (95% CI 1.13 to 1.69) and 3.10 (95% CI 2.93 to 3.27), respectively. On multivariable analysis, patients treated with DOACs had a significantly lower risk of major bleeding compared with those on LMWH or VKA therapy (adjusted HR 0.59; 95% CI 0.48 to 0.74). The adjusted HR in statin users versus non-users was 1.03 (95% CI 0.92 to 1.14), while in statin users on DOACs versus the rest of patients, it was 1.18 (95% CI 0.79 to 1.76).

conclusionsIn patients with VTE receiving statins, long-term anticoagulation with DOACs was associated with a reduced risk of major bleeding, regardless of the statin use. These findings support the safety profile of DOACs over VKAs or LMWH in the management of VTE in patients requiring statins.

Indexed as

AnticoagulantsHemorrhageHydroxymethylglutaryl-CoA Reductase InhibitorsRegistriesVenous ThromboembolismAdministration, OralAgedAged, 80 and overDrug Therapy, CombinationFemaleHeparin, Low-Molecular-WeightHumansMaleMiddle AgedProportional Hazards ModelsRisk FactorsAnticoagulantsHeparin, Low-Molecular-WeightHydroxymethylglutaryl-CoA Reductase InhibitorsVitamin KCLINICAL PHARMACOLOGYGENERAL MEDICINE (see Internal Medicine)INTERNAL MEDICINEVASCULAR MEDICINE

Identifiers

PMID39438090
PMCPMC11590820

What OpenQuestion holds

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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.