Evidence map›Paper›PMID 29188425›Full record

Trial reportJournal of thrombosis and thrombolysis2018

Increased benefit of betrixaban among patients with a history of venous thromboembolism: a post-hoc analysis of the APEX trial.

Megan K Yee, Tarek Nafee, Yazan Daaboul, Serge Korjian, Fahad AlKhalfan, Mathieu Kerneis, Cara Wiest, Samuel Z Goldhaber, Adrian F Hernandez, Russell D Hull and 3 more

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of thrombosis and thrombolysis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01583218 (), 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
2.4field-weighted citation impact, top 11% 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.

NCT01583218 phase3completednot on this map

(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

TypeinterventionalSponsorPortola PharmaceuticalsRan2012 to 2016Enrolled7,513ConditionsVenous Thromboembolism (VTE)ArmsBetrixaban, Enoxaparin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Review
  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

13 authors at 6 institutions in 3 countries.

Megan K YeePERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 20 Overland Street, Boston, MA, 02215, USA.
Tarek NafeePERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 20 Overland Street, Boston, MA, 02215, USA.
Yazan DaaboulPERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 20 Overland Street, Boston, MA, 02215, USA.
Serge KorjianPERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 20 Overland Street, Boston, MA, 02215, USA.
Fahad AlKhalfanPERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 20 Overland Street, Boston, MA, 02215, USA.
Mathieu KerneisPERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 20 Overland Street, Boston, MA, 02215, USA.
Cara WiestPERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 20 Overland Street, Boston, MA, 02215, USA.
Samuel Z GoldhaberCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Adrian F HernandezDuke University and Duke Clinical Research Institute, Durham, NC, USA.
Russell D HullDivision of Cardiology, R.A.H Faculty of Medicine, University of Calgary, Alberta, Canada.
Alexander T CohenGuy's and St Thomas' Hospitals, London, UK.
Robert A HarringtonDepartment of Medicine, Stanford University, Stanford, CA, USA.
C Michael GibsonPERFUSE Study Group, Cardiovascular Division, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 20 Overland Street, Boston, MA, 02215, USA. mgibson@bidmc.harvard.edu.
Beth Israel Deaconess Medical Center · USBrigham and Women's Hospital · USClinical Research Institute · USStanford University · USSt Thomas' Hospital · GBUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hospitalized acute medically ill patients with a history of venous thromboembolism (VTE) are at increased risk for recurrent VTE. We characterized the efficacy and safety of betrixaban for prevention of recurrent VTE in these high risk patients. The APEX trial randomized 7513 acutely ill hospitalized medical patients at risk for developing VTE to receive either betrixaban for 35-42 days or enoxaparin for 10 ± 4 days to prevent VTE. This exploratory post-hoc analysis assessed the efficacy and safety of betrixaban versus enoxaparin among subjects with and without prior VTE. Time-to-multiple symptomatic VTE events was also calculated. Approximately 8% of subjects in both arms had prior VTE, which was associated with a fourfold increase in adjusted risk of VTE [MV OR 4.03, 95% CI 3.06-5.30, p < 0.001]. Betrixaban reduced VTE compared with enoxaparin among subjects with prior VTE [32 (10.4%) vs. 55 (18.9%), RR 0.57, 95% CI 0.38-0.86, p = 0.006, ARR 8.5%, NNT 12] and without prior VTE [133 (3.9%) vs. 168 (4.9%), RR 0.79, 95% CI 0.64-0.99, p = 0.042, ARR 1.0%, NNT 100] (interaction p > 0.05). Additionally, four subjects in the enoxaparin arm and one subject in the betrixaban arm experienced a recurrent VTE. Compared with enoxaparin, betrixaban use was associated with reduction of recurrent VTE events through the active treatment period [36 vs. 57, HR 0.63, 95% CI 0.41-0.97, p = 0.045] and through the end of study [38 vs. 71, HR 0.54, 95% CI 0.36-0.81, p = 0.004]. Prior VTE is associated with a fourfold increase in the risk of VTE among hospitalized medically ill patients. Only 12 such patients would need to be treated with betrixaban versus enoxaparin to prevent an additional VTE endpoint. Betrixaban reduced not only the first but also all recurrent VTE events in a time-to-any-event analysis.

trial registrationhttp://www.clinicaltrials.gov , Unique identifier: NCT01583218.

Indexed as

AdultAgedBenzamidesEnoxaparinFemaleHumansMaleMiddle AgedPyridinesRecurrenceSecondary PreventionTreatment OutcomeVenous ThromboembolismBenzamidesbetrixabanEnoxaparinPyridinesBetrixabanDeep vein thrombosisPulmonary embolismRecurrent venous thromboembolism

Identifiers

PMID29188425
OpenAlexW2770158757

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.