Evidence map›Paper›PMID 34382385›Full record

Trial reportHaematologica2022

Renal function and clinical outcome of patients with cancer-associated venous thromboembolism randomized to receive apixaban or dalteparin. Results from the Caravaggio trial

Cecilia Becattini, Rupert Bauersachs, Giorgio Maraziti, Laurent Bertoletti, Alexander Cohen, Jean M Connors, Dario Manfellotto, Antonio Sanchez, Benjamin Brenner, Giancarlo Agnelli

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03045406 (Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
4.1field-weighted citation impact, top 5% 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.

NCT03045406 phase3completednot on this map

Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study

TypeinterventionalSponsorFadoi Foundation, ItalyRan2017 to 2019Enrolled1,170ConditionsVenous ThromboembolismArmsApixaban, Dalteparin
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. SEOM clinical guidelines on venous thromboembolism (VTE) and cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Apixaban Use in Patients with Kidney Impairment: A Review of Pharmacokinetic, Interventional, and Observational Study Data.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024
    Review
  11. Review
  12. Review
  13. Review
  14. 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 7 institutions in 6 countries.

Cecilia BecattiniInternal, Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia. cecilia.becattini@unipg.it
Rupert BauersachsKlinikum Darmstadt GmbH, Darmstadt
Giorgio MarazitiInternal, Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia
Laurent BertolettiService de Medecine Vasculaire et Therapeutique, CHU de St-Etienne, Saint-Etienne
Alexander CohenDepartment of Haematology, St. Thomas' Hospital, King's College London
Jean M ConnorsBrigham and Women's Hospital/Hematology Division, Harvard Medical School, Boston.
Dario ManfellottoClinical Research Department, FADOI Foundation, Milan, Italy 6 Internal Medicine Department, Fatebenefratelli Foundation, San Giovanni Calibita Fatebenefratelli Hospital, Rome.
Antonio SanchezHospital Puerta de Hierro, Madrid
Benjamin BrennerInstitute of Hematology and BMT Rambam Health Care Campus Technion, Israel Institute of Technology Haifa
Giancarlo AgnelliInternal, Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia
University of Perugia · ITBrigham and Women's Hospital · USFatebenefratelli Hospital · ITHospital Universitario Puerta de Hierro Majadahonda · ESKing's College London · GBKlinikum Darmstadt · DETechnion – Israel Institute of Technology · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The effect of renal impairment (RI) on risk of bleeding and recurrent thrombosis in cancer patients treated with direct oral anticoagulants for venous thromboembolism (VTE) is undefined. We ran a prespecified analysis of the randomized Caravaggio study to evaluate the role of RI as a risk factor for bleeding or recurrence in patients treated with dalteparin or apixaban for cancerassociated VTE. RI was graded as moderate (creatinine clearance between 30-59 mL/minute; 275 patients) and mild (between 60- 89 mL/minute; 444 patients). In the 1142 patients included in this analysis, the incidence of major bleeding was similar in patients with moderate vs. no or mild RI (HR 1.06-95% CI: 0.53-2.11), with no difference in the relative safety of apixaban and dalteparin. Recurrent VTE was not different in moderate vs. no or mild RI (HR=0.67, 95% CI: 0.38-1.20); in moderate RI, apixaban reduced recurrent VTE compared to dalteparin (HR=0.27, 95% CI: 0.08-0.96; P for interaction 0.1085). At multivariate analysis, no association was found between variation of renal function over time and major bleeding or recurrent VTE. Advanced or metastatic cancer was the only independent predictor of major bleeding (HR=2.84, 95% CI: 1.20-6.71), with no effect of treatment with apixaban or dalteparin. In our study, in cancer patients treated with apixaban or dalteparin, moderate RI was not associated with major bleeding or recurrent VTE. In patients with moderate renal failure, the safety profile of apixaban was confirmed with the potential for improved efficacy in comparison to dalteparin. ClinicalTrials.gov identifier: NCT03045406.

Indexed as

NeoplasmsVenous ThromboembolismAnticoagulantsDalteparinHemorrhageHumansKidneyPyrazolesPyridonesAnticoagulantsapixabanDalteparinPyrazolesPyridonesCancer-associated venous thromboembolismCaravaggio trial

Identifiers

PMID34382385
PMCPMC9244816
OpenAlexW3188969827

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.