Evidence map›Paper›PMID 26612979›Full record

ArticleThrombosis journal2015

Safety and efficacy of switching from low molecular weight heparin to dabigatran in patients undergoing elective total hip or knee replacement surgery.

Christian Wurnig, Andreas Clemens, Helmuth Rauscher, Eva Kleine, Martin Feuring, Reinhard Windhager, Josef Grohs

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Thrombosis journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01153698 (Observational Cohort Study to Evaluate the Safety and Efficacy of Switching From Lovenox), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 29% 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.

NCT01153698 terminatednot on this map

Observational Cohort Study to Evaluate the Safety and Efficacy of Switching From Lovenox (Enoxaparin) 40mg to Pradaxa (Dabigatran Etexilate) 220mg in Patients Undergoing Elective Total Hip or Knee Replacement Surgery

TypeobservationalSponsorBoehringer IngelheimRan2010 to 2011Enrolled167ConditionsVenous Thromboembolism, Arthroplasty, ReplacementArmsdabigatran
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Observational
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

7 authors at 4 institutions in 2 countries.

Christian WurnigOrthopaedisches Spital, Speisinger Strasse 109, 1130 Vienna, Austria.
Andreas ClemensCenter for Thrombosis and Hemostasis, University Medical Center Mainz, Mainz, Germany ; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Helmuth RauscherBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Eva KleineBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Martin FeuringBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Reinhard WindhagerDepartment of Orthopaedics, Medical University Vienna, Vienna, Austria.
Josef GrohsDepartment of Orthopaedics, Medical University Vienna, Vienna, Austria.
Boehringer Ingelheim (Germany) · DEMedical University of Vienna · ATOrthopaedic Hospital Speising · ATUniversity Medical Center of the Johannes Gutenberg University Mainz · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this study was to assess the safety and efficacy of switching therapy from low molecular weight heparin (LMWH; enoxaparin) to dabigatran for prevention of venous thromboembolic events (VTE) in patients undergoing elective total hip or knee replacement surgery (THR/TKR).

methodsThis was a prospective, multicenter, open-label, single-arm, observational, study in patients undergoing THR or TKR who were to receive enoxaparin 40 mg for thromboprophylaxis. Enoxaparin was initiated before or after surgery according to local practice, and was switched to dabigatran 220 mg once daily at a time point chosen by the investigator. The coprimary endpoints were major bleeding events, and the composite of symptomatic VTE and all-cause mortality, from last use of enoxaparin to 24 h after last intake of dabigatran.

resultsAltogether, 168 (81 THR, 87 TKR) patients were enrolled, of whom 161 received both enoxaparin and dabigatran, 2 received dabigatran only and 5 received enoxaparin only. The median time of the first dabigatran tablet was 24.0 h after the last LMWH dosage and the median number of days on dabigatran treatment was 36 days. No symptomatic VTE or death occurred during the study. One major bleeding event was seen at the surgical site and required treatment cessation. Three minor bleeding events were observed.

conclusionsIn the normal clinical setting, switching from LMWH to dabigatran in patients who had undergone THR and TKR was safe and effective in preventing VTE. The reported adverse events and serious adverse events were consistent with the known safety profile for dabigatran. Switching from a subcutaneous to an oral anticoagulant may offer greater convenience in the outpatient setting after discharge.

trial registrationClinicalTrials.gov identifier NCT01153698.

Indexed as

DabigatranHip replacement surgeryKnee replacement surgeryLow molecular weight heparinSwitchingThromboprophylaxis

Identifiers

PMID26612979
PMCPMC4660827
OpenAlexW2175578232

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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.