Evidence map›Paper›PMID 30371223›Full record

ArticleJournal of the American Heart Association2018

Selective Serotonin Reuptake Inhibitors and Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation: An Analysis From the ROCKET AF Trial.

Gene R Quinn, Anne S Hellkamp, Graeme J Hankey, Richard C Becker, Scott D Berkowitz, Günter Breithardt, Maurizio Fava, Keith A A Fox, Jonathan L Halperin, Kenneth W Mahaffey and 4 more

Open access · goldAbstract read
In one paragraph

Article in Journal of the American Heart Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 14% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
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  10. DOAC drug interactions management resource.Canadian pharmacists journal : CPJ = Revue des pharmaciens du Canada : RPC · 2022
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  16. Observational
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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

14 authors at 12 institutions in 4 countries.

Gene R Quinn1 Smith Center for Outcomes Research Division of Cardiology Beth Israel Deaconess Medical Center Boston MA.
Anne S Hellkamp4 Duke Clinical Research Institute Duke University School of Medicine Durham NC.
Graeme J Hankey5 Medical School The University of Western Australia Crawley Australia.
Richard C Becker6 University of Cincinnati College of Medicine Cincinnati OH.
Scott D Berkowitz7 Bayer U.S. LLC Parsippany NJ.
Günter Breithardt8 Department of Cardiovascular Medicine Hospital of the University of Münster Germany.
Maurizio Fava2 Harvard Medical School Boston MA.
Keith A A Fox11 University of Edinburgh and Royal Infirmary of Edinburgh United Kingdom.
Jonathan L Halperin12 Mount Sinai School of Medicine New York NY.
Kenneth W Mahaffey13 Department of Medicine Stanford University Stanford CA.
Christopher C Nessel14 Janssen Research & Development Raritan NJ.
Manesh R Patel4 Duke Clinical Research Institute Duke University School of Medicine Durham NC.
Jonathan P Piccini4 Duke Clinical Research Institute Duke University School of Medicine Durham NC.
Daniel E Singer2 Harvard Medical School Boston MA.
Clinical Research Institute · USMassachusetts General Hospital · USAlaska Heart and Vascular Institute · USBayer (United States) · USDuke University · USEdinburgh Royal Infirmary · GBIcahn School of Medicine at Mount Sinai · USJanssen (United States) · USStanford University · USUniversity Hospital Münster · DEUniversity of Cincinnati Medical Center · USUniversity of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background There is concern that selective serotonin reuptake inhibitors ( SSRI s) substantially increase bleeding risk in patients taking anticoagulants. Methods and Results We studied 737 patients taking SSRI s in the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Embolism and Stroke Trial in Atrial Fibrillation) trial of rivaroxaban compared with warfarin for the prevention of stroke/systemic embolism in patients with atrial fibrillation. These patients were propensity score matched 1:1 to 737 patients not taking SSRI s. The primary outcome measure was major and nonmajor clinically relevant bleeding events, the principal safety outcome in ROCKET AF . Over a mean 1.6 years of follow-up, the rate of major/ nonmajor clinically relevant bleeding was 18.57 events/100 patient-years for SSRI users versus 16.84 events/100 patient-years for matched comparators, adjusted hazard ratio ( aHR ) of 1.16 (95% confidence interval [CI], 0.95-1.43). The aHR s were similar in patients taking rivaroxaban ( aHR 1.11 [95% CI, 0.82-1.51]) and those taking warfarin ( aHR 1.21 [95% CI, 0.91-1.60]). For the rarer outcome of major bleeding, the aHR for SSRI users versus those not taking SSRI s was 1.13 (95% CI, 0.62-2.06) for rivaroxaban; for warfarin, the aHR was higher, at 1.58 (95% CI , 0.96-2.60) but not statistically significantly elevated. Conclusions We found no significant increase in bleeding risk when SSRI s were combined with anticoagulant therapy, although there was a suggestion of increased bleeding risk with SSRI s added to warfarin. While physicians should be vigilant regarding bleeding risk, our results provide reassurance that SSRI s can be safely added to anticoagulants in patients with atrial fibrillation . Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifier: NCT 00403767.

Indexed as

AgedAnticoagulantsAnxiety DisordersAtrial FibrillationDepressive DisorderEmbolismFemaleHemorrhageHumansMaleProportional Hazards ModelsRisk FactorsRivaroxabanSelective Serotonin Reuptake InhibitorsStrokeWarfarinAnticoagulantsRivaroxabanSelective Serotonin Reuptake InhibitorsWarfarinanticoagulationatrial fibrillationbleeding riskrivaroxabanselective serotonin reuptake inhibitors

Identifiers

PMID30371223
PMCPMC6201450
OpenAlexW2889915109

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.