Treatment of Cancer-Associated Venous Thromboembolism: 12-month outcomes of the placebo versus rivaroxaban randomisation of the SELECT-D Trial. (SELECT-D: 12m).

Marshall, Andrea, Levine, Mark, Hill, Catherine, Hale, Danielle, Thirlwall, Jenny, Wilkie, Veronica, French, Karen, Kakkar, Ajay, 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 : JTH. ISSN 1538-7836. This article is available to all UHB staff and students login using a UHB Athens Account. Register for Athens here - https://openathens.nice.org.uk/

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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:	Article
Additional Information:	This article is available to all UHB staff and students login using a UHB Athens Account. Register for Athens here - https://openathens.nice.org.uk/
Subjects:	QZ Pathology. Oncology WG Cardiovascular system. Cardiology
Divisions:	Planned IP Care > Oncology and Clinical Haematology
Related URLs:	https://www.ncbi.nlm.nih.gov/pubmed/3199...
Depositing User:	Mrs Yolande Brookes
Date Deposited:	31 Jan 2020 15:01
Last Modified:	05 May 2022 07:25
URI:	http://www.repository.uhblibrary.co.uk/id/eprint/2819

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