Evidence map›Paper›PMID 38567789›Full record

Observational studyEuropean stroke journal2024

Efficacy and safety of oral factor Xa inhibitors versus vitamin-K antagonists in the early phase after acute ischemic stroke or TIA in the real-world setting: The PRODAST study.

Hans-Christoph Diener, Gerrit M Grosse, Anika Hüsing, Andreas Stang, Nils Kuklik, Marcus Brinkmann, Gabriele D Maurer, Hassan Soda, Carsten Pohlmann, Rüdiger Hilker-Roggendorf and 5 more

Open access · hybridAbstract readObservational StudyMulticenter StudyComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in European stroke journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 13% 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

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Efficacy of Factor Xa Inhibitors Versus Placebo in Thromboprophylaxis for Cancer-Associated Thromboembolism: A Systematic Review and Meta-analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  3. 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

15 authors at 10 institutions in 4 countries.

Hans-Christoph DienerInstitute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.ORCID 0000-0002-6556-8612
Gerrit M GrosseInstitute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.ORCID 0000-0002-5335-9880
Anika HüsingInstitute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.
Andreas StangInstitute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.
Nils KuklikInstitute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.
Marcus BrinkmannInstitute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.
Gabriele D MaurerDepartment of Neurology, University Hospital Frankfurt, Goethe University Frankfurt, Germany.
Hassan SodaKlinik für Akutneurologie mit Überregionaler Stroke Unit, Klinischer Neurophysiologie und Intensivmedizin, Rhön-Klinikum Campus Bad Neustadt, Bad Neustadt, Germany.
Carsten PohlmannDepartment of Neurology, Asklepios Klinik Barmbek, Hamburg, Germany.
Rüdiger Hilker-RoggendorfDepartment of Neurology, Klinikum Vest, Recklinghausen.
Nikola PopovicDepartment of Neurology, Evangelisches Krankenhaus Hattingen, Hattingen, Germany.
Peter KraftKlinikum Main-Spessart Lohr, Germany.
Bruno-Marcel MackertDepartment of Neurology, Vivantes Auguste-Viktoria Hospital, Berlin, Germany.
Christoph C EschenfelderHuman Pharma Germany, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.ORCID 0000-0003-2766-2488
Christian WeimarInstitute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany.
Zimmer Biomet (Netherlands) · NLAsklepios Klinik Barmbek · DEAuguste-Viktoria-Klinik · DEBoehringer Ingelheim (Germany) · DEBoston University · USEvangelisches Krankenhaus Düsseldorf · DEGoethe University Frankfurt · DEKlinikum Passau · DEKlinikum Vest · DERhön-Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFactor Xa (FXa) inhibitors are superior to vitamin K antagonists (VKAs) in terms of avoiding hemorrhagic complications. However, no robust data are available to date as to whether this also applies to the early phase after stroke. In this prospective registry study, we aimed to investigate whether anticoagulation with FXa inhibitors in the early phase after acute ischemic stroke or transient ischemic attack (TIA) is associated with a lower risk of major bleeding events compared with VKAs. MATERIALS AND

methodsThe Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA (PRODAST) study is a prospective, multicenter, observational, post-authorization safety study at 86 German stroke units between July 2015 and November 2020. Primary outcome was a major bleeding event during hospital stay. Secondary endpoints were recurrent strokes, recurrent ischemic strokes, TIA, systemic/pulmonary embolism, myocardial infarction, death and the composite endpoint of stroke, systemic embolism, life-threatening bleeding and death.

resultsIn total, 10,039 patients have been recruited. 5,874 patients were treated with FXa inhibitors and 1,050 patients received VKAs and were eligible for this analysis. Overall, event rates were low. We observed 49 major bleeding complications during 33,297 treatment days with FXa-inhibitors (rate of 14.7 cases per 10,000 treatment days) and 16 cases during 7,714 treatment days with VKAs (rate of 20.7 events per 10,000 treatment days), translating into an adjusted hazard ratio (aHR) of 0.70 (95% confidence interval (95% CI): 0.37-1.32) in favor of FXa inhibitors. Hazards for ischemic endpoints (63 vs 17 strokes, aHR: 0.96 (95% CI: 0.53-1.74), mortality (33 vs 6 deaths, aHR: 0.87 (95% CI: 0.33-2.34)) and the combined endpoint (154 vs 39 events, aHR: 0.99 (95% CI: 0.65-1.41) were not substantially different. DISCUSSION AND

conclusionThis large real-world study shows that FXa inhibitors appear to be similarly effective in terms of bleeding events and ischemic endpoints compared to VKAs in the early post-stroke phase of hospitalization. However, the results need to be interpreted with caution due to the low precision of the estimates.

Indexed as

Factor Xa InhibitorsHemorrhageIschemic Attack, TransientIschemic StrokeVitamin KAdministration, OralAgedAged, 80 and overAnticoagulantsDabigatranFemaleHumansMaleMiddle AgedProspective StudiesRegistriesAnticoagulantsDabigatranFactor Xa InhibitorsVitamin KAtrial fibrillationbleedingfactor-Xa-inhibitorsischemic strokerecurrent strokevitamin-K antagonists

Identifiers

PMID38567789
PMCPMC11418467
OpenAlexW4393872232

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.