Evidence map›Paper›PMID 31375070›Full record

ArticleBMC cardiovascular disorders2019

Long-term effectiveness and safety of self-management of oral anticoagulants in real-world settings.

Bárbara Menéndez-Jándula, José Antonio García-Erce, Clara Zazo, Luis Larrad-Mur

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in BMC cardiovascular disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06423521 (Value Analysis in Patients Undergoing Anticoagulant Therapy), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT06423521 nacompletednot on this mapstarted 2021, after this paper: background citation

Value Analysis in Patients Undergoing Anticoagulant Therapy: Impact of Self-management Training Using a Coagulometer

TypeinterventionalSponsorAna Rita Londral, PhDRan2021 to 2024Enrolled28ConditionsPost-Cardiac Surgery PatientsArmsStandard of Care (SOC), Remote Patient Monitoring (RPM)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Article
  3. ChatGPT and Gemini in warfarin counseling.Croatian medical journal · 2026
    Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Bárbara Menéndez-JándulaHospital San Jorge, Av. Martínez de Velasco 36, 22004, Huesca, Spain. bmenendez@aragon.es.
José Antonio García-ErceBanco de Sangre y Tejidos de Navarra, Pamplona, Spain.
Clara ZazoHospital San Jorge, Av. Martínez de Velasco 36, 22004, Huesca, Spain.
Luis Larrad-MurDepartment of Medicine, University of Zaragoza, Zaragoza, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe patient self-management (PSM) is an effective approach for controlling the international normalized ratio, INR, within the therapeutic range. Nevertheless, most of the literature derives from randomized clinical trials, and no from routine clinical practice. The main objective of the present study was to evaluate long-term effectiveness and safety of PSM of oral anticoagulants (OACs) in real-world settings.

methodsThis prospective cohort study involved 808 patients who were trained for PSM between July 2009 and March 2012, and followed-up for a maximum observational period of 5 years. The follow-up consisted of a visit to the physician every 6 months. All patients used the same type of portable coagulometer, able to store digitally up to 100 INR measurements. Effectiveness outcomes included the percentage of patients within the therapeutic range, the time within therapeutic range (TTR), and the evolution of the TTR over 365 days of follow-up. Long-term safety profile of PSM included the incidence of all-cause deaths and complications (thromboembolic or hemorrhagic) reported between July 2009 and June 2014, and the time to event.

resultsThe median follow-up was 3.3 years. The percentage of patients within therapeutic INR target range was 67.5%. The median TTR was 71.5%. The TTR increased over the follow-up period, either overall and regarding target INR. All-cause mortality was 2.4 per 100 patient-years (59 cases). The thromboembolic event rate was 0.9 per 100 patient-years (24 cases). The rate of major hemorrhages was 0.45 per 100 patient-years. Patients who drop out the PSM to perform the conventional management had greater rates of complications: 2.4, 1.8, and 3.4 per 100 patient-years for thromboembolic complications, major hemorrhagic events, and mortality, respectively.

conclusionsThe PSM of OACs is effective for maintaining patients within the INR therapeutic range for a long period of time in routine clinical practice. Results of the present study suggest that its effectiveness is at least comparable to the conventional management. Moreover, it seems safe in real-world settings, by preventing all-cause mortality, and thromboembolic and major hemorrhagic complications.

trial registrationThis study was not a trial, thus registration was not required.

Indexed as

Self-ManagementAdministration, OralAgedAnticoagulantsBlood CoagulationDrug Administration ScheduleDrug MonitoringFemaleHemorrhageHumansInternational Normalized RatioMaleMiddle AgedPredictive Value of TestsProspective StudiesRisk FactorsAnticoagulantsAnticoagulantsCoagulometerEffectivenessOralSafetySelf-management

Identifiers

PMID31375070
PMCPMC6679483

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.