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Treatment of cancer‐associated venous thromboembolism : 12‐month outcomes of the placebo versus rivaroxaban randomisation of the SELECT‐D Trial. (SELECT‐D: 12m)
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Marshall, Andrea, Levine, Mark, Hill, Catherine, Hale, Danielle, Thirlwall, Jenny, Wilkie, Veronica, French, Karen, Kakkar, Ajay K., Lokare, Anand, Maraveyas, Anthony, Chapman, Oliver, Arif, Azra, Petrou, Stavros, Maredza, Mandy, Hobbs, FD Richard, Dunn, Janet A. and Young, Annie M. (2020) Treatment of cancer‐associated venous thromboembolism : 12‐month outcomes of the placebo versus rivaroxaban randomisation of the SELECT‐D Trial. (SELECT‐D: 12m). Journal of Thrombosis and Haemostasis, 18 (4). pp. 905-915. doi:10.1111/jth.14752 ISSN 1538-7933.
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WRAP-treatment-cancer‐associated-venous-thromboembolism-Marshall-2020.pdf - Accepted Version - Requires a PDF viewer. Download (900Kb) | Preview |
Official URL: http://dx.doi.org/10.1111/jth.14752
Abstract
Background:
The SELECT‐D trial demonstrated reduction in recurrent venous thromboembolism (VTE) but increased bleeding with rivaroxaban compared to dalteparin for treatment of acute VTE in cancer patients, at 6 months. Uncertainty remains around optimal duration of anticoagulation.
Objectives:
To assess VTE recurrence and bleeding, with anticoagulation or not, beyond 6 months
Patients/Methods:
In SELECT‐D, after 6 months of trial treatment for VTE, patients with active cancer and residual deep vein thrombosis (RDVT) or index pulmonary embolism (PE) were eligible for randomisation to a further 6 months of rivaroxaban or placebo. Patients with no RDVT stopped anticoagulation. Primary outcome was VTE recurrence at 12 months. The second randomisation closed prematurely due to low recruitment when 92 of the planned 300 patients were recruited.
Results:
92 of 136 eligible patients were randomised to rivaroxaban or placebo. The cumulative VTE recurrence after 6 months from the second randomisation, was 14% with placebo and 4% with rivaroxaban (Hazard Ratio 0.32; 95% CI 0.06‐1.58). The major and clinically‐relevant non‐major bleeding rates were 0% and 0% with placebo; and 5% (95% CI 1‐18%) and 4% (95% CI 1‐17%) with rivaroxaban. In an exploratory analysis, 7 (15.2 %) of 46 placebo patients with RDVT or an index PE experienced recurrent VTE compared to none in the 35 patients in the RDVT‐negative cohort (P=0.03).
Conclusion:
The SELECT‐D trial was underpowered to detect a statistically significant reduction in recurrent VTE with extended anticoagulation. The absence of RDVT and/or index PE, defined a population at low risk of recurrence.
| Item Type: | Journal Article | |||||||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RC Internal medicine R Medicine > RE Ophthalmology R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Thrombosis, Thrombosis -- Cancer, Thrombosis -- Cancer -- Treatment, Thrombophlebitis, Thrombophlebitis -- Treatment, Placebos (Medicine), Anticoagulants (Medicine) | |||||||||
| Journal or Publication Title: | Journal of Thrombosis and Haemostasis | |||||||||
| Publisher: | Wiley-Blackwell Publishing Ltd. | |||||||||
| ISSN: | 1538-7933 | |||||||||
| Official Date: | April 2020 | |||||||||
| Dates: |
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| Volume: | 18 | |||||||||
| Number: | 4 | |||||||||
| Page Range: | pp. 905-915 | |||||||||
| DOI: | 10.1111/jth.14752 | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Reuse Statement (publisher, data, author rights): | This is the peer reviewed version of the following article: Marshall, A., Levine, M., Hill, C., Hale, D., Thirlwall, J., Wilkie, V., French, K., Kakkar, A., Lokare, A., Maraveyas, A., Chapman, O., Arif, A., Petrou, S., Maredza, M., Hobbs, F.R., Dunn, J.A. and Young, A.M. (2020), Treatment of Cancer‐Associated Venous Thromboembolism: 12‐month outcomes of the placebo versus rivaroxaban randomisation of the SELECT‐D Trial. (SELECT‐D: 12m). J Thromb Haemost. Accepted Author Manuscript. doi:10.1111/jth.14752, which has been published in final form at https://doi.org/10.1111/jth.14752. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. | |||||||||
| Access rights to Published version: | Restricted or Subscription Access | |||||||||
| Date of first compliant deposit: | 11 February 2020 | |||||||||
| Date of first compliant Open Access: | 29 January 2021 | |||||||||
| RIOXX Funder/Project Grant: |
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