Evidence map›Paper›PMID 27344439›Full record

Trial reportJournal of thrombosis and thrombolysis2016

A post hoc analysis of dalteparin versus oral anticoagulant (VKA) therapy for the prevention of recurrent venous thromboembolism (rVTE) in patients with cancer and renal impairment.

Seth Woodruff, Guillaume Feugère, Paula Abreu, Joseph Heissler, Marcia T Ruiz, Frank Jen

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of thrombosis and thrombolysis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
3.8field-weighted citation impact, top 6% 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

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Low-molecular-weight heparins for the prevention of recurrent venous thromboembolism in patients with cancer: A systematic literature review of efficacy and cost-effectiveness.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2019
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Incidence, risk factors, and management of bleeding in patients receiving anticoagulants for the treatment of cancer-associated thrombosis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Review
  10. Review
  11. Review
  12. Review
  13. Tinzaparin Sodium Pharmacokinetics in Patients with Chronic Kidney Disease: Practical Implications.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2020
    Review
  14. Review
  15. Review
  16. Dalteparin or vitamin K antagonists to prevent recurrent venous thromboembolism in cancer patients: a patient-level economic analysis for France and Austria.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017
    Article
  17. Article
  18. Article
  19. Venous Thromboembolism In Cancer Patients: "From Evidence to Care".Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    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

6 authors at 2 institutions in 2 countries.

Seth WoodruffPfizer Inc, New York, NY, USA. Seth.Woodruff@Pfizer.com.
Guillaume FeugèrePfizer Inc, Kirkland, QC, Canada.
Paula AbreuPfizer Inc, New York, NY, USA.
Joseph HeisslerPfizer Inc, New York, NY, USA.
Marcia T RuizPfizer Inc, Kirkland, QC, Canada.
Frank JenPfizer Inc, New York, NY, USA.
Pfizer (United States) · USPfizer (Canada) · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Venous thromboembolism (VTE) is a common and serious complication in patients with cancer; treatment guidelines recommend extended therapy of ≥6 months with low-molecular-weight heparin (LMWH) for treatment and prevention of recurrent VTE (rVTE) in this population. This post hoc analysis used data from the CLOT study-a phase III, randomized, open-label, controlled study (N = 676)-to compare the efficacy and safety of dalteparin, a LMWH, versus vitamin K antagonist (VKA) for prevention of rVTE in patients with cancer and renal impairment (creatinine clearance <60 ml/min). Overall, 162/676 (24 %) patients had renal impairment at baseline. Patients received subcutaneous dalteparin 200 IU/kg once daily during month 1, followed by 150 IU/kg once daily for months 2-6; or VKA once daily for 6 months, with initial overlapping subcutaneous dalteparin 200 IU/kg once daily for ≥5 days until international normalized ratio was 2.0-3.0 for 2 consecutive days. Endpoints included the rates of rVTE (primary) and bleeding events. Overall, fewer dalteparin-treated patients (2/74 [2.7 %]) experienced ≥1 adjudicated symptomatic rVTE compared with VKA-treated patients (15/88 [17.0 %]; hazard ratio = 0.15 [95 % confidence interval 0.03-0.65]; p = 0.01). Bleeding event rates for both treatments were similar (p = 0.47). In summary, compared with VKA, dalteparin significantly reduced risk of rVTE in patients with cancer and renal impairment (p = 0.01) while exhibiting a comparable safety profile. This analysis supports dosing patients with renal impairment in accordance with patients with normal renal function; however, anti-Xa monitoring could be considered to further support safety in selected patients, particularly those with very severe renal impairment.

Indexed as

AcenocoumarolAnticoagulantsDalteparinWarfarinAdministration, OralAdultAgedAged, 80 and overFemaleHumansKidney DiseasesMaleMiddle AgedNeoplasmsVenous ThromboembolismVitamin KAcenocoumarolAnticoagulantsDalteparinVitamin KWarfarinDalteparinLow-molecular-weight heparinRenal impairmentThromboembolismVitamin K antagonist

Identifiers

PMID27344439
PMCPMC5040733
OpenAlexW2460097838

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.