Evidence map›Paper›PMID 30186045›Full record

ArticleThrombosis journal2018

COSIMO - patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study.

Alexander T Cohen, Anthony Maraveyas, Jan Beyer-Westendorf, Agnes Y Y Lee, Lorenzo G Mantovani, Miriam Bach, COSIMO Investigators

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Thrombosis journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02742623 (COSIMO Cancer Associated Thrombosis - Patient Reported Outcomes With Rivaroxaban. A Non-interventional Study on Patients Changing to Xarelto® for Treatment of Venous Thromboembolism), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT02742623 completednot on this map

COSIMO Cancer Associated Thrombosis - Patient Reported Outcomes With Rivaroxaban. A Non-interventional Study on Patients Changing to Xarelto® for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer.

TypeobservationalSponsorBayerRan2016 to 2019Enrolled528ConditionsVenous Thrombosis and Pulmonary EmbolismArmsRivaroxaban (Xarelto, BAY 59-7939)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Cancer-associated venous thromboembolism: Treatment and prevention with rivaroxaban.Research and practice in thrombosis and haemostasis · 2020
    Review
  8. Review
  9. Review
  10. Rivaroxaban and the EINSTEIN clinical trial programme.Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis · 2019
    Review
  11. Drug-Drug Interactions of 257 Antineoplastic and Supportive Care Agents With 7 Anticoagulants: A Comprehensive Review of Interactions and Mechanisms.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    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

7 authors.

Alexander T Cohen1Department of Haematological Medicine, Guys and St Thomas' NHS Foundation Trust, King's College London, Westminster Bridge Road, London, UK.
Anthony Maraveyas2Joint Centre for Cancer Studies, Hull York Medical School, QCOH, Castle Hill Hospital, Hull, UK.
Jan Beyer-Westendorf3Thrombosis Research Unit, Department of Medicine I, Division Hematology, University Hospital "Carl Gustav Carus" Dresden, Dresden, Germany.
Agnes Y Y Lee5Division of Hematology, University of British Columbia, British Columbia Cancer Agency, Vancouver, BC Canada.
Lorenzo G Mantovani6CESP-Center for Public Health Research, University of Milan Bicocca, Monza, Italy.
Miriam Bach7Bayer AG, Berlin, Germany.
COSIMO Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAround 20% of venous thromboembolism (VTE) cases occur in patients with cancer. Current guidelines recommend low molecular weight heparin (LMWH) as the preferred anticoagulant for VTE treatment. However, some guidelines state that vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) are acceptable alternatives for long-term therapy in some patients if LMWHs are not available. LMWHs and VKAs have a number of drawbacks that can increase the burden on patients. DOACs, such as rivaroxaban, can ameliorate some burdens and may offer an opportunity to increase patient satisfaction and health-related quality of life (HRQoL). The

methodsCOSIMO is a prospective, non-interventional, single-arm cohort study that aims to recruit 500 patients in Europe, Canada and Australia. Adults with active cancer who are switching to rivaroxaban having received LMWH/VKA for the treatment and secondary prevention of recurrent VTE for at least the previous 4 weeks are eligible. Patients will be followed for 6 months. The primary outcome is treatment satisfaction assessed as change in the Anti-Clot Treatment Scale (ACTS) Burdens score at week 4 after enrolment compared with baseline. Secondary outcomes include treatment preferences, measured using a discrete choice experiment, change in ACTS Burdens score at months 3 and 6, and change in HRQoL (assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire). COSIMO will collect data on patients' medical history, patterns of anticoagulant use and incidence of bleeding and thromboembolic events. Study recruitment started in autumn 2016.

conclusionsCOSIMO will provide information on outcomes associated with switching from LMWH or VKA therapy to rivaroxaban for the treatment or secondary prevention of cancer-associated thrombosis in a real-life setting. The key goal is to assess whether there is a change in patient-reported treatment satisfaction. In addition, COSIMO will facilitate the evaluation of the safety and effectiveness of rivaroxaban in preventing recurrent VTE in this patient population.

trial registrationNCT02742623. Registered 19 April 2016.

Indexed as

Active cancerHealth-related quality of lifeLow molecular weight heparinPatient preferenceRecurrent venous thromboembolismRivaroxabanVitamin K antagonist

Identifiers

PMID30186045
PMCPMC6122180

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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.