Evidence map›Paper›PMID 33805899›Full record

ArticlePharmaceuticals (Basel, Switzerland)2021

Comparison of Direct Oral Anticoagulant Use for the Treatment of Non-Valvular Atrial Fibrillation in Pivotal Clinical Trials vs. the Real-World Setting: A Population-Based Study from Southern Italy.

Ylenia Ingrasciotta, Andrea Fontana, Anna Mancuso, Valentina Ientile, Janet Sultana, Ilaria Uomo, Maurizio Pastorello, Paolo Calabrò, Giuseppe Andò, Gianluca Trifirò

Open access · goldAbstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 52% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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 5 institutions in 1 country.

Ylenia IngrasciottaDepartment of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 98158 Messina, Italy.ORCID 0000-0002-9549-6111
Andrea FontanaUnit of Biostatistics, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, 71013 Foggia, Italy.
Anna MancusoDepartment of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 98158 Messina, Italy.
Valentina IentileDepartment of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 98158 Messina, Italy.
Janet SultanaDepartment of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 98158 Messina, Italy.
Ilaria UomoDepartment of Pharmacy, Palermo Local Health Unit, 90100 Palermo, Italy.
Maurizio PastorelloDepartment of Pharmacy, Palermo Local Health Unit, 90100 Palermo, Italy.
Paolo CalabròDivision of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", 81100 Caserta, Italy.ORCID 0000-0002-5018-830X
Giuseppe AndòDepartment of Clinical and Experimental Medicine, Section of Cardiology, University of Messina, 98158 Messina, Italy.ORCID 0000-0001-5552-6382
Gianluca TrifiròDepartment of Diagnostic Public Health, University of Verona, 37129 Verona, Italy.ORCID 0000-0003-1147-7296
University of Messina · ITUniversity of Palermo · ITCasa Sollievo della Sofferenza · ITUniversity of Campania "Luigi Vanvitelli" · ITUniversity of Verona · IT

Funding

Sanitanova- Headquarters Milano
6 · The paper itself

Abstract

Patients enrolled into pivotal randomized controlled trials (RCTs) may differ substantially from those treated in a real-world (RW) setting, which may result in a different benefit-risk profile. The aim of the study was to assess the external validity of pivotal RCT findings concerning direct oral anticoagulants (DOACs) for the treatment of nonvalvular atrial fibrillation (NVAF) by comparing patients recruited in RCTs to those treated with DOACs registered in a southern Italian local health unit (LHU) in the years 2013-2017. The Palermo LHU claims database was used to describe the baseline characteristics of incident DOAC users (washout > 1 year) with NVAF compared with those of enrolled patients in DOAC pivotal RCTs. In the RW, DOAC treatment discontinuation was calculated during the follow-up and compared with DOAC treatment discontinuation of enrolled patients in DOAC pivotal RCTs. Rates of effectiveness and safety outcomes during the follow-up were calculated in an unmatched and in a simulated RCT population, by matching individual incidental RW and RCT DOAC users (excluding edoxaban users) on age, sex, and CHADS

Indexed as

direct oral anticoagulantsexternal validitynonvalvular atrial fibrillationreal world

Identifiers

PMID33805899
PMCPMC8064382
OpenAlexW3137998893

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.