Tools
Tools
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 via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Full text not available from this repository.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 via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs |
| Subjects: | QZ Pathology. Oncology WG Cardiovascular system. Cardiology |
| Divisions: | Planned IP Care > Oncology and Clinical Haematology |
| Related URLs: | |
| Depositing User: | Mrs Yolande Brookes |
| Date Deposited: | 31 Jan 2020 15:01 |
| Last Modified: | 31 Jan 2020 15:01 |
| URI: | http://www.repository.uhblibrary.co.uk/id/eprint/2819 |
Actions (login required)
 |
View Item |
